1.1 steril Ürünler 1.1 sterile products 1.1.1 aseptik ... · hemodiyaliz çözeltisi 11404000...

1.1 Steril Ürünler 1.1 Sterile Products

1.1.1 Aseptik Hazırlanan Ürünler 1.1.1 Aseptically prepared 1.1.1.1 Büyük Hacimli Sıvılar EDQM KODU1.1.1.1 Large volume liquids Definition (EDQM' de yer alan tanım)Çözeltiler Solutions

Göziçi yıkama çözeltisi 50073500 Solution for intraocular irrigation

Liquid sterile preparation consisting of a solution intended for irrigation of one or more internal structures of the

eye, for example during surgical procedures.

Hemodiyaliz / hemofiltrasyon çözeltisi 50057000 Solution for haemodialysis/haemofiltration

Liquid sterile preparation consisting of a solution intended for use as a solution for haemodialysis or a solution

for haemofiltration.

Hemodiyaliz çözeltisi 11404000 Solution for haemodialysis

Liquid preparation consisting of an aqueous solution containing electrolytes with a concentration close to the

electrolytic composition of plasma, intended for use in haemodialysis. Glucose may be included.

Hemodiyafiltrasyon çözeltisi 11403000 Solution for haemodiafiltration

Liquid sterile preparation consisting of an aqueous solution containing electrolytes with a concentration close to

the electrolytic composition of plasma, intended for parenteral use in haemodiafiltration. Glucose may be

included.

Hemofiltrasyon çözeltisi 11402000 Solution for haemofiltration


the electrolytic composition of plasma, intended for parenteral use in haemofiltration. Glucose may be included.

İnfüzyonluk çözelti için çözelti 13061000 Solution for solution for infusion Liquid sterile preparation consisting of a solution intended for use in the preparation of a solution for infusion.

Kan fraksiyonu modifikasyonu çözeltisi 12103000 Solution for blood fraction modification

Liquid sterile preparation consisting of a solution intended for use in extracorporeal modification of a blood

fraction that is returned to the patient following modification.

Kanın pıhtılaşmasını önleyen ve koruyan çözelti 12102000 Anticoagulant and preservative solution for blood Liquid sterile preparation consisting of an aqueous solution to be mixed with extracorporeal blood.

Kardiyopleji çözeltisi 11209500 Solution for cardioplegia

Liquid sterile preparation consisting of an aqueous solution intended for use in inducing cardiac arrest during

heart surgery. Some preparations may require mixing with other preparations prior to administration, for

example to adjust the pH.

Kardiyopleji/Organ Saklama çözeltisi 13107000 Solution for cardioplegia/organ preservation

Liquid sterile preparation consisting of an aqueous solution of electrolytes typically at a concentration close to

the intracellular electrolyte composition, intended for inducing cardiac arrest during heart surgery, and for

storage, protection and/or perfusion of mammalian body organs that are in particular destined for

transplantation.

Karın zarı içi çözeltisi 12111500 Intraperitoneal solution

Liquid sterile preparation consisting of a solution intended for intraperitoneal use. 'Solution for peritoneal

dialysis' is excluded.

Mesane içi çözelti11502500

Intravesical solution

Liquid preparation consisting of an aqueous solution intended for intravesical use by means of a suitable

applicator. 'Bladder irrigation' is excluded.

Mesane yıkama çözeltisi 11502000 Bladder irrigation

Sterile liquid preparation consisting of sterilised water or an aqueous solution intended for irrigation of the

urinary bladder.

Mide yıkama çözeltisi 12114000 Stomach irrigation Liquid sterile preparation consisting of an aqueous solution intended for irrigation of the stomach.

Organ saklama çözeltisi 12112000 Solution for organ preservation


the intracellular electrolyte composition, intended for storage, protection and/or perfusion of mammalian body

organs that are in particular destined for transplantation.

İnfüzyonluk çözelti 11210000 Solution for infusion

Liquid sterile preparation consisting of an aqueous solution intended to be introduced, usually in large volumes,

usually into the circulating blood stream.

Peritonal diyaliz çözeltisi 11401000 Solution for peritoneal dialysis


the electrolytic composition of plasma and glucose in varying concentrations or other suitable osmotic agents,

intended for intraperitoneal use as a dialysis solution.

Yıkama çözeltisi 12113000 Irrigation solution

Liquid sterile preparation consisting of a large-volume aqueous solution intended for irrigation of body cavities,

wounds and surfaces, for example during surgical procedures. Irrigation solutions are either solutions of active

substance(s), electrolytes or osmotically active substances in water for injections, or they consist of water for

injections as such.

Çözücüler Solvents

Göz içi yıkama çözeltisi çözücüsü 50074000 Solvent for solution for intraocular irrigation

Liquid sterile preparation consisting of a solvent containing no active substances, intended for use in the

preparation of a solution for intraocular irrigation.

İnfüzyonluk çözelti çözücüsü 50076000 Solvent for solution for infusion


preparation of a solution for infusion.

Parenteral kullanım için çözücü 11216000 Solvent for parenteral use


preparation of a product for parenteral use.

Konsantreler Concentrates

Konsantre infüzyonluk çözelti için konsantre 13001000

Concentrate for concentrate for solution for infusionLiquid sterile preparation intended to be diluted in the specified liquid to obtain a concentrate for solution for

infusion, which in turn is intended to be diluted in the specified liquid to obtain a solution for infusion.

Göziçi yıkama çözeltisi için konsantre 10600500Concentrate for solution for intraocular irrigation Liquid sterile preparation intended to be diluted in the specified liquid to obtain a solution for intraocular

irrigation.

Hemodiyaliz çözeltisi için konsantre 11405000Concentrate for solution for haemodialysis Liquid preparation consisting of an aqueous solution of electrolytes intended to be diluted with water of a

suitable quality to obtain a solution for haemodialysis. Glucose may be included.

İnfüzyonluk çözelti için konsantre 11213000

Concentrate for solution for infusionLiquid sterile preparation consisting of an aqueous solution intended to be diluted in the specified aqueous liquid

to obtain a solution for infusion. It may be added to a solution for infusion during the administration.

İnfüzyonluk dispersiyon için konsantre 50009300Concentrate for dispersion for infusion

Liquid sterile preparation intended to be diluted in the specified liquid to obtain a dispersion for infusion.

İnfüzyonluk emülsiyon için konsantre 50009500Concentrate for emulsion for infusion

Liquid sterile preparation intended to be diluted in the specified liquid to obtain an emulsion for infusion.

Karın zarı diyalizi çözeltisi için konsantre50013250

Concentrate for solution for peritoneal dialysisLiquid sterile preparation intended to be diluted in the specified liquid to obtain a solution for peritoneal dialysis.

Mesaneiçi çözeltisi için konsantre 50009750 Concentrate for intravesical solution Liquid preparation intended to be diluted in the specified liquid to obtain an intravesical solution.

Dispersiyonlar DispersionDispersiyon için infüzyonluk konsantre dispersiyon

13005000

Dispersion for concentrate for dispersion for infusion Liquid sterile preparation consisting of a dispersion intended for use in the preparation of a concentrate for

dispersion for infusion, which in turn is intended to be diluted in the specified liquid to obtain a dispersion for

infusion.

İnfüzyonluk dispersiyon 50017500

Dispersion for infusionLiquid sterile preparation consisting of two or more phases of which at least one is dispersed in the liquid phase,

intended to be introduced, usually in large volumes, usually into the circulating blood stream. To be used only

when emulsion for infusion is not appropriate. Solid suspension preparations are excluded.

Emülsiyonlar Emulsions

İnfüzyonluk emülsiyon 11211000Emulsion for infusion Liquid sterile preparation consisting of an oil-in-water emulsion intended to be introduced, usually in large

volumes, usually into the circulating blood stream.

Süspansiyonlar Suspensions

İmplantasyon süspansiyonu 11303500Implantation suspension Liquid sterile preparation consisting of a suspension intended for implantation in the body; the active

substance(s) are released over an extended period of time to obtain a local or systemic effect.

1.1.1.2 Liyofilize Ürünler 1.1.1.2 Lyophilisates

1.1.1.3 Yarı Katılar 1.1.1.3 Semi-solids

Jel Gel

Enjeksiyonluk jel 11204000Gel for injection Sterile single-dose preparation consisting of a hydrophilic gel intended for injection into a specific tissue or

organ.

Göz jeli 10602000

Eye gelSemi-solid sterile single-dose or multidose preparation consisting of a gel intended for ocular use. Eye gels may

be presented in collapsible tubes fitted with a cannula and having a content of not more than 5 g of the

preparation. Eye gels may also be presented in suitably designed single-dose containers. The containers or

nozzles of tubes are of a shape that facilitates administration without contamination.

Üretra jeli 11504000Urethral gel

Semi-solid preparation consisting of a gel intended for urethral use by means of a suitable applicator.

Krem Cream

Göz kremi 10601000

Eye creamSemi-solid sterile single-dose or multidose preparation consisting of a cream intended for ocular use. Eye creams

may be presented in collapsible tubes fitted with a cannula and having a content of not more than 5 g of the

preparation. Eye creams may also be presented in suitably designed single-dose containers. The containers or


Köpük Foam

Merhem Ointment

Göz merhemi 10603000

Eye ointmentSemi-solid sterile single-dose or multidose preparation consisting of an ointment intended for ocular use. Eye

ointments may be presented in collapsible tubes fitted with a cannula and having a content of not more than 5 g

of the preparation. Eye ointments may also be presented in suitably designed single-dose containers. The

containers or nozzles of tubes are of a shape that facilitates administration without contamination.

Kulak / göz merhemi 50019000 Ear/eye ointment Semi-solid preparation consisting of an ointment intended for auricular or ocular use.

Patlar Paste

İmplantasyon patı 13043000 Implantation paste

Semi-solid sterile preparation containing large proportions of solids finely dispersed in the basis, intended to be

implanted in the body for release of the active substance(s) over an extended period of time, usually to obtain a

systemic effect.

1.1.1.4 Küçük Hacimli Sıvılar 1.1.1.4 Small volume liquids

Çözeltiler SolutionsDeri çizik testi çözeltisi

10549000 Solution for skin-scratch test

Liquid sterile preparation consisting of a solution containing an allergen product intended for diagnostic use in a

skin-scratch test.

Deri prik testi çözeltisi10548000 Solution for skin-prick test


skin-prick test.

Doku yapıştırıcısı 12115000 Sealant Liquid, more or less viscous, sterile preparation intended for use as tissue glue.

Enjeksiyonluk / infüzyonluk çözelti50060000 Solution for injection/infusion

Liquid sterile single-dose or multidose preparation consisting of a solution intended for administration by

injection or infusion.

Enjeksiyonluk çözelti11201000 Solution for injection


injection.

Enjeksiyonluk çözelti için çözelti13033000 Solution for solution for injection Liquid sterile preparation consisting of a solution intended for use in the preparation of a solution for injection.

Enjeksiyonluk süspansiyon için çözelti13047000 Solution for suspension for injection

Liquid sterile preparation consisting of a solution intended for use in the preparation of a suspension for

injection.

Enjeksiyonluk uzatılmış salımlı çözelti13076000 Prolonged-release solution for injection

Liquid sterile preparation consisting of a solution intended for administration by injection; the active

substance(s) are released over an extended period of time.

Enjeksiyonluk/deri çizme testi için çözelti

13051000 Solution for injection/skin-prick test


skin-prick test or as an injection (usually intraepidermal); it may also be licensed for immunotherapy treatment

by injection (usually subcutaneous).

Göz damlası, çözelti 10604000 Eye drops, solution

Liquid sterile single-dose or multidose preparation consisting of an aqueous or oily solution intended for ocular

use. Multidose preparations are presented in containers that allow successive drops to be administered. The

containers contain usually at most 10 mL of the preparation.

Göz içi damlatma çözeltisi13044000 Intraocular instillation solution

Liquid sterile preparation consisting of a solution intended to be instilled as drops into an internal part of the

eye.

Göz losyonu 10610000 Eye lotion

Liquid sterile single-dose or multidose preparation consisting of an aqueous solution intended for washing or

bathing the eye.

Göziçi yıkama çözeltisi50073500 Solution for intraocular irrigation



İnfüzyonluk çözelti için çözelti13061000 Solution for solution for infusion Liquid sterile preparation consisting of a solution intended for use in the preparation of a solution for infusion.

Kan fraksiyonu modifikasyonu çözeltisi12103000 Solution for blood fraction modification




Kardiyopleji çözeltisi

11209500 Solution for cardioplegia




Kulak / göz damlası, çözelti 50018000 Ear/eye drops, solution Liquid sterile preparation consisting of a solution intended for use as ear drops or eye drops.

Kulak/göz/burun damlası, çözelti50019500 Ear/eye/nasal drops, solution Liquid sterile preparation consisting of a solution intended for use as ear drops, eye drops or nasal drops.

Mesane içi çözelti11502500 Intravesical solution



Mesane içi çözeltisi/enjeksiyonluk çözelti50033400 Intravesical solution/solution for injection Liquid sterile preparation consisting of a solution intended for intravesical use or for administration by injection.

İnfüzyonluk çözelti11210000 Solution for infusion



Doku yapıştırıcı çözelti 50061500 Solution for sealant Liquid sterile preparation consisting of a solution intended for the preparation of a sealant.

Yara çözeltisi 13042000 Epilesional solution Liquid sterile preparation consisting of a solution intended to be administered onto a lesion.


Göz damlası hazırlama çözücüsü 10608000 Eye drops, solvent for reconstitution

Liquid preparation consisting of a sterile solvent containing no active substances, intended for reconstitution of

a usually freeze-dried powder for eye drops.




Göz losyonu hazırlama çözücüsü 10611000 Eye lotion, solvent for reconstitution


a usually freeze-dried powder for eye lotion.







Damlalar Drops

Uzatılmış salımlı göz damlası 10609000 Eye drops, prolonged-release

Liquid sterile single-dose or multidose preparation intended for ocular use. The active substance is released over

an extended period of time.

Konsantreler ConcentratesKonsantre infüzyonluk çözelti için konsantre

13001000 Concentrate for concentrate for solution for infusion

Liquid sterile preparation intended to be diluted in the specified liquid to obtain a concentrate for solution for


Enjeksiyonluk çözelti için konsantre11209000 Concentrate for solution for injection Liquid sterile preparation intended to be diluted in the specified liquid to obtain a solution for injection.

Enjeksiyonluk süspansiyon için konsantre13004000 Concentrate for suspension for injection Liquid sterile preparation intended to be diluted in the specified liquid to obtain a suspension for injection.

Göziçi yıkama çözeltisi için konsantre10600500 Concentrate for solution for intraocular irrigation

Liquid sterile preparation intended to be diluted in the specified liquid to obtain a solution for intraocular

irrigation.

Hemodiyaliz çözeltisi için konsantre11405000 Concentrate for solution for haemodialysis

Liquid preparation consisting of an aqueous solution of electrolytes intended to be diluted with water of a


İnfüzyonluk çözelti için konsantre

11213000 Concentrate for solution for infusion

Liquid sterile preparation consisting of an aqueous solution intended to be diluted in the specified aqueous liquid


İnfüzyonluk dispersiyon için konsantre50009300 Concentrate for dispersion for infusion Liquid sterile preparation intended to be diluted in the specified liquid to obtain a dispersion for infusion.

İnfüzyonluk emülsiyon için konsantre50009500 Concentrate for emulsion for infusion Liquid sterile preparation intended to be diluted in the specified liquid to obtain an emulsion for infusion.

İnfüzyonluk/enjeksiyonluk çözelti için konsantre50079000 Concentrate for solution for injection/infusion Liquid sterile preparation intended to be diluted in the specified liquid to obtain a solution for injection/infusion.

Karın zarı diyalizi çözeltisi için konsantre50013250 Concentrate for solution for peritoneal dialysis Liquid sterile preparation intended to be diluted in the specified liquid to obtain a solution for peritoneal dialysis.


Dispersiyonlar DispersionsDispersiyon için infüzyonluk konsantre dispersiyon

13005000 Dispersion for concentrate for dispersion for infusion

Liquid sterile preparation consisting of a dispersion intended for use in the preparation of a concentrate for


infusion.

Enjeksiyonluk dispersiyon 50077000 Dispersion for injection

Liquid sterile preparation consisting of two or more phases of which at least one is dispersed in the liquid phase,

intended for administration by injection. To be used only when emulsion for injection is not appropriate. Solid

suspension preparations are excluded.

İnfüzyonluk dispersiyon

50017500 Dispersion for infusion

Liquid sterile preparation consisting of two or more phases of which at least one is dispersed in the liquid phase,



İnfüzyonluk/enjeksiyonluk dispersiyon

13049000 Dispersion for injection/infusion

Sterile liquid preparation consisting of two or more phases of which at least one is dispersed in the liquid phase,

intended for administration by injection or infusion. To be used only when emulsion for injection/infusion is not

appropriate. Solid suspension preparations are excluded.


Enjeksiyonluk / infüzyonluk emülsiyon 50021000Emulsion for injection/infusion Liquid sterile single-dose or multidose preparation consisting of an emulsion intended for administration by


Enjeksiyonluk emülsiyon 11203000Emulsion for injection Liquid sterile single-dose or multidose preparation consisting of an emulsion intended for administration by

injection.

Enjeksiyonluk emülsiyon için emülsiyon 13008000Emulsion for emulsion for injection Liquid sterile preparation consisting of an emulsion intended for use in the preparation of an emulsion for

injection.

Enjeksiyonluk süspansiyon için emülsiyon 13091000Emulsion for suspension for injection Liquid sterile preparation consisting of an emulsion intended for use in the preparation of a suspension for

injection.

Göz damlası, emülsiyon 10604500

Eye drops, emulsion Liquid sterile single-dose or multidose preparation consisting of an emulsion intended for ocular use. Multidose

preparations are presented in containers that allow successive drops to be administered. The containers contain

usually at most 10 mL of the preparation.



Üretral emülsiyon 13077000Urethral emulsion

Liquid preparation consisting of an emulsion intended for urethral use by means of a suitable applicator.


Enjeksiyonluk emülsiyon için süspansiyon 13036000Suspension for emulsion for injection Liquid sterile preparation consisting of a suspension intended for use in the preparation of an emulsion for

injection.

Enjeksiyonluk süspansiyon 11202000Suspension for injection Liquid sterile single-dose or multidose preparation consisting of a suspension intended for administration by

injection.

Enjeksiyonluk süspansiyon için süspansiyon 13039000Suspension for suspension for injection Liquid sterile preparation consisting of a suspension intended for use in the preparation of a suspension for

injection.

Enjeksiyonluk uzatılmış salımlı süspansiyon 11208500Prolonged-release suspension for injection Liquid sterile preparation consisting of a suspension intended for administration by injection; the active


Göz damlası, süspansiyon 10605000

Eye drops, suspension Liquid sterile single-dose or multidose preparation consisting of an aqueous or oily suspension intended for

ocular use. Multidose preparations are presented in containers that allow successive drops to be administered.

The containers contain usually at most 10 mL of the preparation.



Kulak/göz damlası, süspansiyon 50018500 Ear/eye drops, suspension Liquid sterile preparation consisting of a suspension intended for use as ear drops or eye drops.

Mesane içi süspansiyon 13045000Intravesical suspension Liquid preparation consisting of a small-volume suspension intended for intravesical use by means of a suitable

applicator.

1.1.1.5 Katılar ve İmplantlar 1.1.1.5 Solids and implants

Çubuklar Sticks

Üretra çubuğu 11505000

Urethral stickSolid sterile single-dose preparation, usually rod-shaped and of a size adapted to the dimensions of the urethra,

intended for insertion into the urethra. They may be prepared by compression or moulding.

Yara çubuğu 12104000

Wound stick Solid sterile single-dose preparation, usually rod-shaped or conical, consisting of active substance(s) dissolved or

dispersed in a suitable basis that may dissolve or melt at body temperature, intended to be inserted into

wounds.

Doyurulmuş Matrisler Impregnated Materials

Göz şeridi 10613000Ophthalmic strip Solid sterile single-dose preparation consisting of a strip made of a suitable material usually impregnated with

active substance(s) intended for use on the eyeball.

İmplantasyon matrisi için matris 13018000Matrix for implantation matrix Solid sterile preparation consisting of a usually pliable, absorbent piece of material (e.g. collagen) intended to be

used in the preparation of an implantation matrix.

Yapıştırıcı matris 12115100

Sealant matrix Solid sterile preparation consisting of a pliable piece of material impregnated or coated with a sealant or with a

powder that forms a sealant after contact with an appropriate fluid (e.g. blood). It may act as a haemostatic

agent and/or tissue glue. The matrix may itself form part of the seal, and is usually absorbed by the body over

time.

Granüller Granules

Enjeksiyonluk süspansiyon için granül 13048000Granules for suspension for injection Solid sterile preparation consisting of granules intended to be dispersed in the specified liquid to obtain a

suspension for injection.

İmplantlar Implants

İmplant

11301000

ImplantSolid sterile preparation of a size and shape suitable for implantation. It may be prepared by moulding or other

means other than compression. Each implant is presented in a sterile container that may be provided with an

administration device. Implants are intended for release over an extended period of time in order to obtain local

or systemic effect. 'Implantation tablet', 'Implantation chain' and 'Implantation matrix' are excluded.

İmplantasyon matriksi 11303300

Implantation matrixSolid sterile preparation consisting of a usually pliable, absorbent piece of material (e.g. collagen), usually

impregnated with a liquid preparation, intended for implantation in the body. The material may be cut into

smaller pieces before implantation, and may be shaped around a tissue (e.g. a bone) or inserted into a medical

device that is then implanted. Implantation matrices are intended for release over an extended period of time,

usually in order to obtain a local effect. Usually the matrix disappears with time. When the product is packaged

as a separate matrix, powder and solvent (or matrix and solution), which are used to prepare the implantation

matrix immediately before use, the appropriate combined term should be used; see for example ‘Powder,

solvent and matrix for implantation matrix’.

İmplantasyon zinciri 11303000

Implantation chain Solid sterile preparation consisting of small spheres mounted on a non-degradable thread to form a chain that

allows withdrawal of the remainder of the chain after a certain period of action. Each implantation chain is

presented in a sterile container. The implantation chain is intended for release over an extended period of time

in order to obtain local or systemic effect.

İnsertler Inserts

Göz diski 10612000

Ophthalmic insertSolid sterile preparation of suitable size and shape, designed to be inserted in the conjunctival sac to produce a

local or ocular effect by the release of active substance(s) over a determined period of time. Ophthalmic inserts

generally consist of a reservoir of active substance(s) embedded in a matrix or bounded by a rate-controlling

membrane. They are presented individually in sterile containers.

Tabletler Tablets

İmplantasyon tableti 11302000

Implantation tablet Solid sterile preparation prepared by compression of a solid active substance as such or of a formulation thereof

into an implant of a size and shape suitable for implantation, usually subcutaneously. Each implantation tablet is

presented in a sterile container. Implantation tablets are intended for release over an extended period of time in

order to obtain local or systemic effect.

Tozlar PowdersDeri çizme testi için çözeltilik toz 13032000 Powder for solution for skin-prick test Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain a solution for skin-prick test.

Enjeksiyon için uzatılmış salımlı süspansiyonluk toz 11208400 Powder for prolonged-release suspension for injectionSolid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dispersed in the specified liquid to obtain a prolonged-release suspension for injection.

Enjeksiyonluk çözelti tozu 11205000 Powder for solution for injection Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain a solution for injection.

Enjeksiyonluk çözelti/mesaneiçi çözeltisi için toz 50050500 Powder for intravesical solution/solution for injectionSolid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain an intravesical solution/solution for injection.

Enjeksiyonluk dispersiyon için toz 13023000 Powder for dispersion for injection Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dispersed in the specified liquid to obtain a dispersion for injection.

Enjeksiyonluk emülsiyon için toz 13040000 Powder for emulsion for injection Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

mixed with the specified liquid to obtain an emulsion for injection.

Enjeksiyonluk süspansiyon tozu 11206000 Powder for suspension for injection Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dispersed in the specified liquid to obtain a suspension for injection.

Enjeksiyonluk/deri çizme testi için çözeltilik toz 13052000 Powder for solution for injection/skin-prick test Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain a solution for injection/skin-prick test.

Enjeksiyonluk/infüzyonluk çözelti için konsantrelik toz 50049250 Powder for concentrate for solution for injection/infusionSolid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain a concentrate for solution for injection/infusion, which must

subsequently be diluted before administration as a solution for injection/infusion.

Göz damlası, çözeltilik toz 13010000 Eye drops, powder for solution Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain an eye drops solution.

Göz damlası, süspansiyonluk toz 13011000 Eye drops, powder for suspension Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed

in the specified liquid to obtain an eye drops suspension.

Göz içi yıkama çözeltisi tozu 50073000 Powder for solution for intraocular irrigation Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain a solution for intraocular irrigation.

Göziçi damlatma çözeltisi için toz 13029000 Powder for intraocular instillation solution Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain an intraocular instillation solution.

Hemodiyaliz çözeltisi için konsantrelik toz 50049200 Powder for concentrate for solution for haemodialysis Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain a concentrate for solution for haemodialysis, which must subsequently

be diluted before use as a solution for haemodialysis.

İmplantason süspansiyonu için toz 50049500 Powder for implantation suspension Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dispersed in the specified liquid to obtain an implantation suspension.

İmplantasyon matrisi için toz 13027000 Powder for implantation matrix Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be used

in the preparation of an implantation matrix, e.g. by dissolving in the specified liquid to prepare the solution

used to impregnate the matrix.

İmplantasyon matrisi patı için toz 13028000 Powder for implantation paste Solid sterile preparation consisting of one or more powders intended to be mixed with the specified liquid or

paste to obtain an implantation paste.

İnfüzyonluk çözelti için toz 11212000 Powder for solution for infusion Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified aqueous liquid to obtain a solution for infusion.

İnfüzyonluk çözelti için konsantrelik toz 50043000 Powder for concentrate for solution for infusion Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain a concentrate for solution for infusion, which must subsequently be

diluted before administration as a solution for infusion.

İnfüzyonluk dispersiyon için konsantrelik toz 50048750 Powder for concentrate for dispersion for infusion Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dispersed in the specified liquid to obtain a concentrate for dispersion for infusion, which must subsequently be

diluted before administration as a dispersion for infusion.

İnfüzyonluk dispersiyon için toz 11211500 Powder for dispersion for infusion Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dispersed in the specified liquid to obtain a dispersion for infusion.

İnfüzyonluk/enjeksiyonluk çözelti için toz 50053500 Powder for solution for injection/infusion Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain a solution for injection/infusion.

Mesane yıkama çözeltisi için toz 11503000 Powder for bladder irrigation Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in sterile water to obtain a bladder irrigation.

Mesaneiçi süspansiyonu için konsantrelik toz 50049100 Powder for concentrate for intravesical suspension Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dispersed in the specified liquid to obtain a concentrate for intravesical suspension, which must subsequently be

diluted before administration as an intravesical suspension.

Doku yapıştırıcı için toz 13031000 Powder for sealant Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain a sealant.

Doku yapıştırıcı toz 12115200 Sealant powder Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

applied directly onto the intended site (e.g. a lesion) to form a haemostatic agent and/or tissue glue after

contact with an appropriate fluid (e.g. blood).

Yara çözeltisi için toz 50049300 Powder for epilesional solution Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain an epilesional solution.

1.1.1.6 Diğer Aseptik Hazırlanan Ürünler (Açıklama giriniz.) 1.1.1.6 Other aseptically prepared products (…clarify) Doku yapıştırıcı toz ve çözücüsü 12116000 Powder and solvent for sealant Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a sealant by

dissolving the powder in the solvent.

Doz dağıtımlı kartuşta enjeksiyonluk çözelti 13071000 Solution for injection in dose-dispenser cartridge Medicinal product consisting of a solution for injection presented in a dose-dispenser cartridge.

Enjeksiyonluk çözelti için toz ve çözelti 50041500 Powder and solution for solution for injectionSterile powder (including freeze-dried powder) and sterile solution, both containing active substance(s),

intended for the preparation of a solution for injection by dissolving the powder in the solution.

Enjeksiyonluk çözelti için konsantre ve toz 50007000 Concentrate and solvent for solution for injection Sterile concentrate and sterile solvent intended for the preparation of a solution for injection by diluting the

concentrate with the solvent.

Enjeksiyonluk çözelti tozu ve çözücüsü 11207000 Powder and solvent for solution for injection Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a solution for

injection by dissolving the powder in the solvent.

Enjeksiyonluk dispersiyon için toz ve çözücü 50044500 Powder and solvent for dispersion for injection Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a dispersion

for injection by dispersing the powder in the solvent.

Enjeksiyonluk emülsiyon için emülsiyon ve süspansiyon 50021500 Emulsion and suspension for emulsion for injection Sterile emulsion and sterile suspension, both of which contain active substance(s), intended for the preparation

of an emulsion for injection by mixing the emulsion and the suspension.

Enjeksiyonluk emülsiyon için toz ve çözücü 50044700 Powder and solvent for emulsion for injection Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of an emulsion

for injection by mixing the powder and the solvent.

Enjeksiyonluk süspansiyon granülü ve çözücüsü 50027000 Granules and solvent for suspension for injection Sterile granules and sterile solvent intended for the preparation of a suspension for injection by dispersing the

granules in the solvent.

Enjeksiyonluk süspansiyon için toz ve süspansiyon 50048500 Powder and suspension for suspension for injectionSterile powder (including freeze-dried powder) and sterile suspension, both of which contain active substance(s),

intended for the preparation of a suspension for injection by dispersing the powder in the suspension.

Enjeksiyonluk süspansiyon için konsantre ve çözücü 50008000 Concentrate and solvent for suspension for injection Sterile concentrate and sterile solvent intended for the preparation of a suspension for injection by diluting the


Enjeksiyonluk süspansiyon tozu ve çözücüsü 11208000 Powder and solvent for suspension for injection Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a suspension


Enjeksiyonluk/deri çizme testi çözeltisi için toz ve çözücü 50048270 Powder and solvent for solution for injection/skin-prick test Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a solution for

injection/skin-prick test by dissolving the powder in the solvent.

Enjeksiyonluk/infüzyonluk çözelti için toz ve çözücü 50080000 Powder and solvent for solution for injection/infusion Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a solution for

injection/infusion by dissolving the powder in the solvent.

Göz damlası süspansiyonluk toz ve çözücüsü 10607000 Eye drops, powder and solvent for suspension Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of eye drops,

suspension, by dispersing the powder in the solvent.

Göz damlası, tek dozluk kapta çözelti 50023000 Eye drops, solution in single-dose container Medicinal product consisting of an eye drops solution presented in a single-dose container.

Göz damlası, tek dozluk kapta emülsiyon 13104000 Eye drops, emulsion in single-dose container Medicinal product consisting of an eye drops emulsion presented in a single-dose container.

Göz damlası, tek dozluk kapta süspansiyon 50023100 Eye drops, suspension in single-dose container Medicinal product consisting of an eye drops suspension presented in a single-dose container.

Göz damlası, tek dozluk kapta uzatılmış salımlı çözelti 50022500 Eye drops, prolonged-release solution in single-dose containerMedicinal product consisting of a prolonged-release eye drops solution presented in a single-dose container.

Göz damlası, toz ve çözücüsü 10606000 Eye drops, powder and solvent for solution Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of eye drops,

solution, by dissolving the powder in the solvent.

Göz içine uygulanan damlatma çözelti tozu ve çözücüsü 50047000 Powder and solvent for intraocular instillation solution Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of an intraocular

instillation solution by dissolving the powder in the solvent.

Hazır şırıngada implantasyon 50029750 Implant in pre-filled syringe Medicinal product consisting of an implant presented in a pre-filled syringe.

İğnesiz enjektörde enjeksiyonluk çözelti 50060150 Solution for injection in needle-free injector Medicinal product consisting of a solution for injection presented in a needle-free injector.

İmplantasyon matrisi için toz, çözücü ve matris 50055350 Powder, solvent and matrix for implantation matrix Sterile powder (including freeze-dried powder), sterile solvent and sterile matrix intended for the preparation of

an implantation matrix, for example by dissolving the powder in the solvent and using the resulting solution to

impregnate the matrix.

İmplantasyon patı için toz ve çözücü 11304000 Powder and solvent for implantation paste Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of an

implantation paste by dispersing the powder in the solvent.

İnfüzyonluk çözelti için konsantrelik toz ve çözelti 13062000 Powder for concentrate and solution for solution for infusion Medicinal product consisting of a powder for concentrate for solution for infusion and a solution for solution for

infusion, intended for the preparation of a solution for infusion.

İnfüzyonluk çözelti konsantre ve çözücüsü 50006000 Concentrate and solvent for solution for infusion Sterile concentrate and sterile solvent intended for the preparation of a solution for infusion by diluting the


İnfüzyonluk çözelti konsantresi tozu ve çözücüsü 50042000 Powder and solvent for concentrate for solution for infusionSterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a concentrate

fo solution for infusion by dissolving the powder in the solvent; the resulting concentrate for solution for

infusion must subsequently be diluted before administration as a solution for infusion.

İnfüzyonluk çözelti tozu ve çözücüsü 11214000 Powder and solvent for solution for infusion Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a solution for

infusion by dissolving the powder in the solvent.

İnfüzyonluk/enjeksiyonluk çözelti için çözücü ve konsantre 50007500 Concentrate and solvent for solution for injection/infusion Sterile concentrate and sterile solvent intended for the preparation of a solution for injection/infusion by

diluting the concentrate with the solvent.

İnfüzyonluk/enjeksiyonluk dispersiyon için gaz ve çözücü 50078000 Gas and solvent for dispersion for injection/infusionSterile gas and sterile solvent, either in the same compartment or in different compartments, intended for the

preparation of a dispersion for injection/infusion by dispersing the gas in the solvent.

İntravitreal implant uygulayıcı 50033500 Intravitreal implant in applicator Medicinal product consisting of an intravitreal implant presented in an applicator.

Kartuşta enjeksiyonluk çözelti 50060100 Solution for injection in cartridge Medicinal product consisting of a solution for injection presented in a cartridge.

Kartuşta enjeksiyonluk çözelti için toz ve çözücü 50048050 Powder and solvent for solution for injection in cartridge Medicinal product consisting of a powder and solvent for solution for injection presented in a cartridge. The

powder and solvent are contained in different compartments of the cartridge, which contains all of the

components necessary to prepare the solution for injection.

Kartuşta enjeksiyonluk süspansiyon 50063100 Suspension for injection in cartridge Medicinal product consisting of a suspension for injection presented in a cartridge.

Konsantre infüzyonluk çözelti konsantre ve çözücüsü 50002000 Concentrate and solvent for concentrate for solution for infusion Sterile concentrate and sterile solvent intended for the preparation of a concentrate for solution for infusion by

diluting the concentrate with the solvent; the resulting concentrate for solution for infusion must subsequently

be diluted again before administration as a solution for infusion.

Konsantre infüzyonluk dispersiyon için toz, dispersiyon ve çözücü 50048600 Powder, dispersion and solvent for concentrate for dispersion for infusionSterile powder (including freeze-dried powder) and sterile dispersion, both of which contain active substance(s),

and sterile solvent intended for the preparation of a concentrate for dispersion for infusion; it is prepared as

specified in the packaging information; the resulting concentrate for dispersion for infusion must subsequently

be diluted before administration as a dispersion for infusion.

Kullanıma hazır enjektörde enjeksiyonluk çözelti 13068000 Solution for injection in pre-filled injector Medicinal product consisting of a solution for injection presented in a pre-filled injector.

Kullanıma hazır enjektörde enjeksiyonluk süspansiyon 13064000 Suspension for injection in pre-filled injector Medicinal product consisting of a suspension for injection presented in a pre-filled injector.

Kullanıma hazır kalemde enjeksiyonluk çözelti 50060200 Solution for injection in pre-filled pen Medicinal product consisting of a solution for injection presented in a pre-filled pen.

Kullanıma hazır kalemde enjeksiyonluk çözelti için toz ve çözücü 50048150 Powder and solvent for solution for injection in pre-filled pen Medicinal product consisting of a powder and solvent for solution for injection presented in a pre-filled pen. The

powder and solvent are contained in different compartments of the pre-filled pen, which contains all of the


Kullanıma hazır kalemde enjeksiyonluk süspansiyon 50063200 Suspension for injection in pre-filled pen Medicinal product consisting of a suspension for injection presented in a pre-filled pen.

Kullanıma hazır kalemde enjeksiyonluk uzatılmış salımlı süspansiyon için toz ve çözücü50048010 Powder and solvent for prolonged-release suspension for injection in pre-filled penMedicinal product consisting of a powder and solvent for prolonged-release suspension for injection presented

in a pre-filled pen. The powder and solvent are contained in different compartments of the pre-filled pen, which

contains all of the components necessary to prepare the prolonged-release suspension for injection.

Kullanıma hazır şırıngada enjeksiyonluk çözelti 50060300 Solution for injection in pre-filled syringe Medicinal product consisting of a solution for injection presented in a pre-filled syringe.

Kullanıma hazır şırıngada enjeksiyonluk çözelti için toz ve çözücü 50048250 Powder and solvent for solution for injection in pre-filled syringe Medicinal product consisting of a powder and solvent for solution for injection presented in a pre-filled syringe.

The powder and solvent are contained in different compartments of the pre-filled syringe, which contains all of

the components necessary to prepare the solution for injection.

Kullanıma hazır şırıngada enjeksiyonluk süspansiyon 50063300 Suspension for injection in pre-filled syringe Medicinal product consisting of a suspension for injection presented in a pre-filled syringe.

Kullanıma hazır şırıngada enjeksiyonluk süspansiyon için çözelti ve süspansiyon 50056600 Solution and suspension for suspension for injection in pre-filled syringeMedicinal product consisting of a solution and suspension for suspension for injection presented in a pre-filled

syringe. The solution and suspension are contained in different compartments of the pre-filled syringe, which

contains all of the components necessary to prepare the suspension for injection.

Kullanıma hazır şırıngada enjeksiyonluk süspansiyon için toz ve çözücü 50048300 Powder and solvent for suspension for injection in pre-filled syringe Medicinal product consisting of a powder and solvent for suspension for injection presented in a pre-filled

syringe. The powder and solvent are contained in different compartments of the pre-filled syringe, which


Kullanıma hazır şırıngada enjeksiyonluk uzatılmış salımlı süspansiyon 50056250 Prolonged-release suspension for injection in pre-filled syringeMedicinal product consisting of a prolonged-release suspension for injection presented in a pre-filled syringe.

Kullanıma hazır şırıngada enjeksiyonluk uzatılmış salımlı süspansiyon için toz ve çözücü13057000 Powder and solvent for prolonged-release suspension for injection in pre-filled syringeMedicinal product consisting of a powder and solvent for prolonged-release suspension for injection presented

in a pre-filled syringe. The powder and solvent are contained in different compartments of the pre-filled syringe,

which contains all of the components necessary to prepare the prolonged-release suspension for injection.

Kullanıma hazır şırıngada enjeksiyonluk/infüzyonluk çözelti 50060500 Solution for injection/infusion in pre-filled syringe Medicinal product consisting of a solution for injection/infusion presented in a pre-filled syringe.

Kullanıma hazır şırıngada enjeksiyonluk/infüzyonluk emülsiyon 50021250 Emulsion for injection/infusion in pre-filled syringe Medicinal product consisting of an emulsion for injection/infusion presented in a pre-filled syringe.

Kullanıma hazır şırıngada infüzyonluk çözelti 50058500 Solution for infusion in pre-filled syringe Medicinal product consisting of a solution for infusion presented in a pre-filled syringe.

Radyofarmasötik ana çözeltisi 12105000 Radiopharmaceutical precursor A radionuclide produced for the radio-labelling of another substance prior to administration.

Radyofarmasötik hazırlamak için kit 12107000

Kit for radiopharmaceutical preparationA preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually prior

to its administration. The word radiopharmaceutical may be omitted if there is no ambiguity on the

radiopharmaceutical nature of the product. Combinations with other standard terms are not recommended.

Radyofarmasötik öncül, çözelti 50056500Radiopharmaceutical precursor, solution Liquid preparation consisting of a solution containing a radionuclide produced for the radio-labelling of another

substance prior to administration.

Tek dozluk kapta göz jeli 50023300 Eye gel in single-dose container Medicinal product consisting of an eye gel presented in a single-dose container.

Tek dozluk kapta göz merhemi 50023400 Eye ointment in single-dose container Medicinal product consisting of an eye ointment presented in a single-dose container.

Uygulama sisteminde enjeksiyonluk çözelti 13053000 Solution for injection in administration system Medicinal product consisting of a solution for injection presented in an administration system.

Uygulama sisteminde infüzyonluk çözelti 11210500 Solution for infusion in administration system Medicinal product consisting of a solution for infusion presented in an administration system.

Uygulama sisteminde infüzyonluk emülsiyon 13095000 Emulsion for infusion in administration system Medicinal product consisting of an emulsion for infusion presented in an administration system.

Uzatılmış salımlı enjeksiyonluk süspansiyon tozu ve çözücüsü 50048000 Powder and solvent for prolonged-release suspension for injection Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a prolonged-

release suspension for injection by dispersing the powder in the solvent.

Yara çözeltisi için toz ve çözücü 50045500 Powder and solvent for epilesional solution Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of an epilesional

solution by dissolving the powder in the solvent.

1.1.2 Son Kabında Sterilize Edilen Ürünler 1.1.2 Terminally sterilized

1.1.2.1 Büyük Hacimli Sıvılar 1.1.2.1 Large volume liquids

Çözeltiler Solutions

Göziçi yıkama çözeltisi 50073500 Solution for intraocular irrigation



Hemodiyaliz / hemofiltrasyon çözeltisi 50057000 Solution for haemodialysis/haemofiltration

Liquid sterile preparation consisting of a solution intended for use as a solution for haemodialysis or a solution

for haemofiltration.

Hemodiyaliz çözeltisi 11404000 Solution for haemodialysis

Liquid preparation consisting of an aqueous solution containing electrolytes with a concentration close to the

electrolytic composition of plasma, intended for use in haemodialysis. Glucose may be included.

Hemodiyafiltrasyon çözeltisi 11403000 Solution for haemodiafiltration


the electrolytic composition of plasma, intended for parenteral use in haemodiafiltration. Glucose may be

included.

Hemofiltrasyon çözeltisi 11402000 Solution for haemofiltration


the electrolytic composition of plasma, intended for parenteral use in haemofiltration. Glucose may be included.

İnfüzyonluk çözelti için çözelti 13061000 Solution for solution for infusion Liquid sterile preparation consisting of a solution intended for use in the preparation of a solution for infusion.

Kan fraksiyonu modifikasyonu çözeltisi 12103000 Solution for blood fraction modification




Kardiyopleji çözeltisi 11209500 Solution for cardioplegia




Kardiyopleji/Organ Saklama çözeltisi 13107000 Solution for cardioplegia/organ preservation


the intracellular electrolyte composition, intended for inducing cardiac arrest during heart surgery, and for

storage, protection and/or perfusion of mammalian body organs that are in particular destined for

transplantation.

Karın zarı içi çözeltisi 12111500 Intraperitoneal solution

Liquid sterile preparation consisting of a solution intended for intraperitoneal use. 'Solution for peritoneal

dialysis' is excluded.

Mesane içi çözelti11502500

Intravesical solution



Mesane yıkama çözeltisi 11502000 Bladder irrigation

Sterile liquid preparation consisting of sterilised water or an aqueous solution intended for irrigation of the

urinary bladder.

Mide yıkama çözeltisi 12114000 Stomach irrigation Liquid sterile preparation consisting of an aqueous solution intended for irrigation of the stomach.

Organ saklama çözeltisi 12112000 Solution for organ preservation


the intracellular electrolyte composition, intended for storage, protection and/or perfusion of mammalian body

organs that are in particular destined for transplantation.

İnfüzyonluk çözelti 11210000 Solution for infusion



Peritonal diyaliz çözeltisi 11401000 Solution for peritoneal dialysis


the electrolytic composition of plasma and glucose in varying concentrations or other suitable osmotic agents,

intended for intraperitoneal use as a dialysis solution.

Yıkama çözeltisi 12113000 Irrigation solution

Liquid sterile preparation consisting of a large-volume aqueous solution intended for irrigation of body cavities,

wounds and surfaces, for example during surgical procedures. Irrigation solutions are either solutions of active

substance(s), electrolytes or osmotically active substances in water for injections, or they consist of water for

injections as such.












Konsantre infüzyonluk çözelti için konsantre 13001000



Göziçi yıkama çözeltisi için konsantre 10600500Concentrate for solution for intraocular irrigation Liquid sterile preparation intended to be diluted in the specified liquid to obtain a solution for intraocular

irrigation.

Hemodiyaliz çözeltisi için konsantrat 11405000Concentrate for solution for haemodialysis Liquid preparation consisting of an aqueous solution of electrolytes intended to be diluted with water of a


İnfüzyonluk çözelti için konsantrat 11213000



İnfüzyonluk dispersiyon için konsantre 50009300Concentrate for dispersion for infusion

Liquid sterile preparation intended to be diluted in the specified liquid to obtain a dispersion for infusion.

İnfüzyonluk emülsiyon için konsantre 50009500Concentrate for emulsion for infusion

Liquid sterile preparation intended to be diluted in the specified liquid to obtain an emulsion for infusion.




Dispersiyonlar Disperions

Dispersiyon için infüzyonluk konsantre dispersiyon

13005000



infusion.

İnfüzyonluk dispersiyon 50017500











Jel Gel

Enjeksiyonluk jel 11204000Gel for injection Sterile single-dose preparation consisting of a hydrophilic gel intended for injection into a specific tissue or

organ.

Göz jeli 10602000

Eye gelSemi-solid sterile single-dose or multidose preparation consisting of a gel intended for ocular use. Eye gels may

be presented in collapsible tubes fitted with a cannula and having a content of not more than 5 g of the

preparation. Eye gels may also be presented in suitably designed single-dose containers. The containers or


Üretra jeli 11504000Urethral gel

Semi-solid preparation consisting of a gel intended for urethral use by means of a suitable applicator.

Krem Cream

Göz kremi 10601000

Eye creamSemi-solid sterile single-dose or multidose preparation consisting of a cream intended for ocular use. Eye creams

may be presented in collapsible tubes fitted with a cannula and having a content of not more than 5 g of the

preparation. Eye creams may also be presented in suitably designed single-dose containers. The containers or


Köpük Foam

Merhem Ointment

Göz merhemi 10603000

Eye ointmentSemi-solid sterile single-dose or multidose preparation consisting of an ointment intended for ocular use. Eye

ointments may be presented in collapsible tubes fitted with a cannula and having a content of not more than 5 g

of the preparation. Eye ointments may also be presented in suitably designed single-dose containers. The

containers or nozzles of tubes are of a shape that facilitates administration without contamination.

Kulak / göz merhemi 50019000 Ear/eye ointment Semi-solid preparation consisting of an ointment intended for auricular or ocular use.

Patlar Paste

İmplantasyon patı 13043000 Implantation paste

Semi-solid sterile preparation containing large proportions of solids finely dispersed in the basis, intended to be

implanted in the body for release of the active substance(s) over an extended period of time, usually to obtain a

systemic effect.

1.1.2.3 Küçük Hacimli Sıvılar 1.1.2.3 Small volume liquids


Deri çizik testi çözeltisi10549000 Solution for skin-scratch test


skin-scratch test.

Deri prik testi çözeltisi10548000 Solution for skin-prick test


skin-prick test.

Doku yapıştırıcısı 12115000 Sealant Liquid, more or less viscous, sterile preparation intended for use as tissue glue.

Enjeksiyonluk / infüzyonluk çözelti50060000 Solution for injection/infusion



Enjeksiyonluk çözelti11201000 Solution for injection


injection.

Enjeksiyonluk çözelti için çözelti13033000 Solution for solution for injection Liquid sterile preparation consisting of a solution intended for use in the preparation of a solution for injection.

Enjeksiyonluk süspansiyon için çözelti13047000 Solution for suspension for injection

Liquid sterile preparation consisting of a solution intended for use in the preparation of a suspension for

injection.

Enjeksiyonluk uzatılmış salımlı çözelti13076000 Prolonged-release solution for injection

Liquid sterile preparation consisting of a solution intended for administration by injection; the active


Enjeksiyonluk/deri çizme testi için çözelti

13051000 Solution for injection/skin-prick test


skin-prick test or as an injection (usually intraepidermal); it may also be licensed for immunotherapy treatment

by injection (usually subcutaneous).

Göz damlası, çözelti 10604000 Eye drops, solution

Liquid sterile single-dose or multidose preparation consisting of an aqueous or oily solution intended for ocular

use. Multidose preparations are presented in containers that allow successive drops to be administered. The

containers contain usually at most 10 mL of the preparation.

Göz içi damlatma çözeltisi13044000 Intraocular instillation solution

Liquid sterile preparation consisting of a solution intended to be instilled as drops into an internal part of the

eye.

Göz losyonu 10610000 Eye lotion

Liquid sterile single-dose or multidose preparation consisting of an aqueous solution intended for washing or

bathing the eye.

Göziçi yıkama çözeltisi50073500 Solution for intraocular irrigation



İnfüzyonluk çözelti için çözelti13061000 Solution for solution for infusion Liquid sterile preparation consisting of a solution intended for use in the preparation of a solution for infusion.

Kan fraksiyonu modifikasyonu çözeltisi12103000 Solution for blood fraction modification




Kardiyopleji çözeltisi

11209500 Solution for cardioplegia




Kulak / göz damlası, çözelti 50018000 Ear/eye drops, solution Liquid sterile preparation consisting of a solution intended for use as ear drops or eye drops.

Kulak/göz/burun damlası, çözelti50019500 Ear/eye/nasal drops, solution Liquid sterile preparation consisting of a solution intended for use as ear drops, eye drops or nasal drops.

Mesane içi çözelti11502500 Intravesical solution



Mesane içi çözeltisi/enjeksiyonluk çözelti50033400 Intravesical solution/solution for injection Liquid sterile preparation consisting of a solution intended for intravesical use or for administration by injection.

İnfüzyonluk çözelti11210000 Solution for infusion



Doku yapıştırıcı çözelti 50061500 Solution for sealant Liquid sterile preparation consisting of a solution intended for the preparation of a sealant.

Yara çözeltisi 13042000 Epilesional solution Liquid sterile preparation consisting of a solution intended to be administered onto a lesion.


Göz damlası hazırlama çözücüsü 10608000 Eye drops, solvent for reconstitution


a usually freeze-dried powder for eye drops.




Göz losyonu hazırlama çözücüsü 10611000 Eye lotion, solvent for reconstitution


a usually freeze-dried powder for eye lotion.







Damlalar Drops

Uzatılmış salımlı göz damlası 10609000 Eye drops, prolonged-release

Liquid sterile single-dose or multidose preparation intended for ocular use. The active substance is released over

an extended period of time.

Konsantreler ConcentratesEnjeksiyonluk çözelti için konsantre

11209000Concentrate for solution for injection

Liquid sterile preparation intended to be diluted in the specified liquid to obtain a solution for injection.

Enjeksiyonluk süspansiyon için konsantre13004000

Concentrate for suspension for injectionLiquid sterile preparation intended to be diluted in the specified liquid to obtain a suspension for injection.

Göziçi yıkama çözeltisi için konsantre10600500

Concentrate for solution for intraocular irrigation Liquid sterile preparation intended to be diluted in the specified liquid to obtain a solution for intraocular

irrigation.

Hemodiyaliz çözeltisi için konsantre11405000

Concentrate for solution for haemodialysis Liquid preparation consisting of an aqueous solution of electrolytes intended to be diluted with water of a


İnfüzyonluk çözelti için konsantre

11213000



İnfüzyonluk dispersiyon için konsantre50009300

Concentrate for dispersion for infusionLiquid sterile preparation intended to be diluted in the specified liquid to obtain a dispersion for infusion.

İnfüzyonluk emülsiyon için konsantre50009500

Concentrate for emulsion for infusionLiquid sterile preparation intended to be diluted in the specified liquid to obtain an emulsion for infusion.

İnfüzyonluk/enjeksiyonluk çözelti için konsantre50079000

Concentrate for solution for injection/infusionLiquid sterile preparation intended to be diluted in the specified liquid to obtain a solution for injection/infusion.



Konsantre infüzyonluk çözelti için konsantre

13001000




Dispersiyonlar Dispersions

Dispersiyon için infüzyonluk konsantre dispersiyon

13005000



infusion.

Enjeksiyonluk dispersiyon 50077000

Dispersion for injection Liquid sterile preparation consisting of two or more phases of which at least one is dispersed in the liquid phase,

intended for administration by injection. To be used only when emulsion for injection is not appropriate. Solid

suspension preparations are excluded.

İnfüzyonluk dispersiyon

50017500




İnfüzyonluk/enjeksiyonluk dispersiyon

13049000

Dispersion for injection/infusion Sterile liquid preparation consisting of two or more phases of which at least one is dispersed in the liquid phase,

intended for administration by injection or infusion. To be used only when emulsion for injection/infusion is not

appropriate. Solid suspension preparations are excluded.


Enjeksiyonluk / infüzyonluk emülsiyon 50021000Emulsion for injection/infusion Liquid sterile single-dose or multidose preparation consisting of an emulsion intended for administration by


Enjeksiyonluk emülsiyon 11203000Emulsion for injection Liquid sterile single-dose or multidose preparation consisting of an emulsion intended for administration by

injection.

Enjeksiyonluk emülsiyon için emülsiyon 13008000Emulsion for emulsion for injection Liquid sterile preparation consisting of an emulsion intended for use in the preparation of an emulsion for

injection.

Enjeksiyonluk süspansiyon için emülsiyon 13091000Emulsion for suspension for injection Liquid sterile preparation consisting of an emulsion intended for use in the preparation of a suspension for

injection.

Göz damlası, emülsiyon 10604500

Eye drops, emulsion Liquid sterile single-dose or multidose preparation consisting of an emulsion intended for ocular use. Multidose

preparations are presented in containers that allow successive drops to be administered. The containers contain

usually at most 10 mL of the preparation.






Enjeksiyonluk emülsiyon için süspansiyon 13036000Suspension for emulsion for injection Liquid sterile preparation consisting of a suspension intended for use in the preparation of an emulsion for

injection.

Enjeksiyonluk süspansiyon 11202000Suspension for injection Liquid sterile single-dose or multidose preparation consisting of a suspension intended for administration by

injection.

Enjeksiyonluk süspansiyon için süspansiyon 13039000Suspension for suspension for injection Liquid sterile preparation consisting of a suspension intended for use in the preparation of a suspension for

injection.

Enjeksiyonluk uzatılmış salımlı süspansiyon 11208500Prolonged-release suspension for injection Liquid sterile preparation consisting of a suspension intended for administration by injection; the active


Göz damlası, süspansiyon 10605000

Eye drops, suspension Liquid sterile single-dose or multidose preparation consisting of an aqueous or oily suspension intended for

ocular use. Multidose preparations are presented in containers that allow successive drops to be administered.

The containers contain usually at most 10 mL of the preparation.



Kulak/göz damlası, süspansiyon 50018500 Ear/eye drops, suspension Liquid sterile preparation consisting of a suspension intended for use as ear drops or eye drops.

Mesane içi süspansiyon 13045000Intravesical suspension Liquid preparation consisting of a small-volume suspension intended for intravesical use by means of a suitable

applicator.

1.1.2.4 Katılar ve İmplantlar 1.1.2.4 Solids and implants

Çubuklar Sticks

Üretra çubuğu 11505000

Urethral stickSolid sterile single-dose preparation, usually rod-shaped and of a size adapted to the dimensions of the urethra,

intended for insertion into the urethra. They may be prepared by compression or moulding.

Yara çubuğu 12104000

Wound stick Solid sterile single-dose preparation, usually rod-shaped or conical, consisting of active substance(s) dissolved or

dispersed in a suitable basis that may dissolve or melt at body temperature, intended to be inserted into

wounds.

Doyurulmuş Matrisler Impregnated Materials

Göz şeridi 10613000Ophthalmic strip Solid sterile single-dose preparation consisting of a strip made of a suitable material usually impregnated with

active substance(s) intended for use on the eyeball.

İmplantasyon matrisi için matris 13018000Matrix for implantation matrix Solid sterile preparation consisting of a usually pliable, absorbent piece of material (e.g. collagen) intended to be

used in the preparation of an implantation matrix.

Yapıştırıcı matris 12115100

Sealant matrix Solid sterile preparation consisting of a pliable piece of material impregnated or coated with a sealant or with a

powder that forms a sealant after contact with an appropriate fluid (e.g. blood). It may act as a haemostatic

agent and/or tissue glue. The matrix may itself form part of the seal, and is usually absorbed by the body over

time.

Granüller Granules

Enjeksiyonluk süspansiyon için granül 13048000Granules for suspension for injection Solid sterile preparation consisting of granules intended to be dispersed in the specified liquid to obtain a

suspension for injection.

İmplantlar Implants

İmplant

11301000

ImplantSolid sterile preparation of a size and shape suitable for implantation. It may be prepared by moulding or other

means other than compression. Each implant is presented in a sterile container that may be provided with an

administration device. Implants are intended for release over an extended period of time in order to obtain local

or systemic effect. 'Implantation tablet', 'Implantation chain' and 'Implantation matrix' are excluded.

İmplantasyon zinciri 11303000

Implantation matrixSolid sterile preparation consisting of a usually pliable, absorbent piece of material (e.g. collagen), usually

impregnated with a liquid preparation, intended for implantation in the body. The material may be cut into

smaller pieces before implantation, and may be shaped around a tissue (e.g. a bone) or inserted into a medical

device that is then implanted. Implantation matrices are intended for release over an extended period of time,

usually in order to obtain a local effect. Usually the matrix disappears with time. When the product is packaged

as a separate matrix, powder and solvent (or matrix and solution), which are used to prepare the implantation

matrix immediately before use, the appropriate combined term should be used; see for example ‘Powder,

solvent and matrix for implantation matrix’.

İmplantasyon matriksi 11303300

Implantation chain Solid sterile preparation consisting of small spheres mounted on a non-degradable thread to form a chain that

allows withdrawal of the remainder of the chain after a certain period of action. Each implantation chain is

presented in a sterile container. The implantation chain is intended for release over an extended period of time

in order to obtain local or systemic effect.

İnsertler Inserts

Göz diski 10612000

Ophthalmic insertSolid sterile preparation of suitable size and shape, designed to be inserted in the conjunctival sac to produce a

local or ocular effect by the release of active substance(s) over a determined period of time. Ophthalmic inserts

generally consist of a reservoir of active substance(s) embedded in a matrix or bounded by a rate-controlling

membrane. They are presented individually in sterile containers.

Tabletler Tablets

Implantasyon tableti 11302000 Implantasyon tableti

Solid sterile preparation prepared by compression of a solid active substance as such or of a formulation thereof

into an implant of a size and shape suitable for implantation, usually subcutaneously. Each implantation tablet is

presented in a sterile container. Implantation tablets are intended for release over an extended period of time in

order to obtain local or systemic effect.

Tozlar PowdersDeri çizme testi için çözeltilik toz 13032000 Powder for solution for skin-prick test Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain a solution for skin-prick test.

Enjeksiyon için uzatılmış salımlı süspansiyonluk toz 11208400 Powder for prolonged-release suspension for injectionSolid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dispersed in the specified liquid to obtain a prolonged-release suspension for injection.

Enjeksiyonluk çözelti tozu 11205000 Powder for solution for injection Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain a solution for injection.

Enjeksiyonluk çözelti/mesaneiçi çözeltisi için toz 50050500 Powder for intravesical solution/solution for injectionSolid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain an intravesical solution/solution for injection.

Enjeksiyonluk dispersiyon için toz 13023000 Powder for dispersion for injection Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dispersed in the specified liquid to obtain a dispersion for injection.

Enjeksiyonluk emülsiyon için toz 13040000 Powder for emulsion for injection Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

mixed with the specified liquid to obtain an emulsion for injection.

Enjeksiyonluk süspansiyon tozu 11206000 Powder for suspension for injection Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dispersed in the specified liquid to obtain a suspension for injection.

Enjeksiyonluk/deri çizme testi için çözeltilik toz 13052000 Powder for solution for injection/skin-prick test Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain a solution for injection/skin-prick test.

Enjeksiyonluk/infüzyonluk çözelti için konsantrelik toz 50049250 Powder for concentrate for solution for injection/infusionSolid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain a concentrate for solution for injection/infusion, which must

subsequently be diluted before administration as a solution for injection/infusion.

Göz damlası, çözeltilik toz 13010000 Eye drops, powder for solution Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain an eye drops solution.

Göz damlası, süspansiyonluk toz 13011000 Eye drops, powder for suspension Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed

in the specified liquid to obtain an eye drops suspension.

Göz içi yıkama çözeltisi tozu 50073000 Powder for solution for intraocular irrigation Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain a solution for intraocular irrigation.

Göziçi damlatma çözeltisi için toz 13029000 Powder for intraocular instillation solution Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain an intraocular instillation solution.

Hemodiyaliz çözeltisi için konsantrelik toz 50049200 Powder for concentrate for solution for haemodialysis Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain a concentrate for solution for haemodialysis, which must subsequently

be diluted before use as a solution for haemodialysis.

İmplantason süspansiyonu için toz 50049500 Powder for implantation suspension Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dispersed in the specified liquid to obtain an implantation suspension.

İmplantasyon matrisi için toz 13027000 Powder for implantation matrix Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be used

in the preparation of an implantation matrix, e.g. by dissolving in the specified liquid to prepare the solution

used to impregnate the matrix.

İmplantasyon matrisi patı için toz 13028000 Powder for implantation paste Solid sterile preparation consisting of one or more powders intended to be mixed with the specified liquid or

paste to obtain an implantation paste.

İnfüzyonluk çözelti için toz 11212000 Powder for solution for infusion Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified aqueous liquid to obtain a solution for infusion.

İnfüzyonluk çözelti konsantresi tozu 50043000 Powder for concentrate for solution for infusion Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain a concentrate for solution for infusion, which must subsequently be

diluted before administration as a solution for infusion.

İnfüzyonluk dispersiyon için konsantrelik toz 50048750 Powder for concentrate for dispersion for infusion Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dispersed in the specified liquid to obtain a concentrate for dispersion for infusion, which must subsequently be

diluted before administration as a dispersion for infusion.

İnfüzyonluk dispersiyon için toz 11211500 Powder for dispersion for infusion Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dispersed in the specified liquid to obtain a dispersion for infusion.

İnfüzyonluk/enjeksiyonluk çözelti için toz 50053500 Powder for solution for injection/infusion Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain a solution for injection/infusion.

Mesane yıkama çözeltisi için toz 11503000 Powder for bladder irrigation Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in sterile water to obtain a bladder irrigation.

Mesaneiçi süspansiyonu için konsantrelik toz 50049100 Powder for concentrate for intravesical suspension Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dispersed in the specified liquid to obtain a concentrate for intravesical suspension, which must subsequently be

diluted before administration as an intravesical suspension.

Yapıştırıcı için toz 13031000 Powder for sealant Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain a sealant.

Yapıştırıcı toz 12115200 Sealant powder Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

applied directly onto the intended site (e.g. a lesion) to form a haemostatic agent and/or tissue glue after

contact with an appropriate fluid (e.g. blood).

Yara çözeltisi için toz 50049300 Powder for epilesional solution Solid sterile preparation consisting of one or more powders, including freeze-dried powders, intended to be

dissolved in the specified liquid to obtain an epilesional solution.

1.1.2.5 Diğer Son Kabında Sterilize Edilen Ürünler 1.1.2.5 Other terminally sterilized products (…clarify) Doku yapıştırıcı toz ve çözücüsü 12116000 Powder and solvent for sealant Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a sealant by


Doz dağıtımlı kartuşta enjeksiyonluk çözelti 13071000 Solution for injection in dose-dispenser cartridge Medicinal product consisting of a solution for injection presented in a dose-dispenser cartridge.

Enjeksiyonluk çözelti için toz ve çözelti 50041500 Powder and solution for solution for injectionSterile powder (including freeze-dried powder) and sterile solution, both containing active substance(s),

intended for the preparation of a solution for injection by dissolving the powder in the solution.

Enjeksiyonluk çözelti konsantre ve çözücüsü 50007000 Concentrate and solvent for solution for injection Sterile concentrate and sterile solvent intended for the preparation of a solution for injection by diluting the


Enjeksiyonluk çözelti tozu ve çözücüsü 11207000 Powder and solvent for solution for injection Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a solution for

injection by dissolving the powder in the solvent.

Enjeksiyonluk dispersiyon için toz ve çözücü 50044500 Powder and solvent for dispersion for injection Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a dispersion


Enjeksiyonluk emülsiyon için emülsiyon ve süspansiyon 50021500 Emulsion and suspension for emulsion for injection Sterile emulsion and sterile suspension, both of which contain active substance(s), intended for the preparation

of an emulsion for injection by mixing the emulsion and the suspension.

Enjeksiyonluk emülsiyon için toz ve çözücü 50044700 Powder and solvent for emulsion for injection Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of an emulsion

for injection by mixing the powder and the solvent.

Enjeksiyonluk süspansiyon granülü ve çözücüsü 50027000 Granules and solvent for suspension for injection Sterile granules and sterile solvent intended for the preparation of a suspension for injection by dispersing the

granules in the solvent.

Enjeksiyonluk süspansiyon için toz ve süspansiyon 50048500 Powder and suspension for suspension for injectionSterile powder (including freeze-dried powder) and sterile suspension, both of which contain active substance(s),

intended for the preparation of a suspension for injection by dispersing the powder in the suspension.

Enjeksiyonluk süspansiyon için konsantre ve çözücü 50008000 Concentrate and solvent for suspension for injection Sterile concentrate and sterile solvent intended for the preparation of a suspension for injection by diluting the


Enjeksiyonluk süspansiyon tozu ve çözücüsü 11208000 Powder and solvent for suspension for injection Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a suspension


Enjeksiyonluk/deri çizme testi çözeltisi için toz ve çözücü 50048270 Powder and solvent for solution for injection/skin-prick test Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a solution for

injection/skin-prick test by dissolving the powder in the solvent.

Enjeksiyonluk/infüzyonluk çözelti için toz ve çözücü 50080000 Powder and solvent for solution for injection/infusion Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a solution for

injection/infusion by dissolving the powder in the solvent.

Göz damlası süspansiyonluk toz ve çözücüsü 10607000 Eye drops, powder and solvent for suspension Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of eye drops,

suspension, by dispersing the powder in the solvent.

Göz damlası, tek dozluk kapta çözelti 50023000 Eye drops, solution in single-dose container Medicinal product consisting of an eye drops solution presented in a single-dose container.

Göz damlası, tek dozluk kapta emülsiyon 13104000 Eye drops, emulsion in single-dose container Medicinal product consisting of an eye drops emulsion presented in a single-dose container.

Göz damlası, tek dozluk kapta süspansiyon 50023100 Eye drops, suspension in single-dose container Medicinal product consisting of an eye drops suspension presented in a single-dose container.

Göz damlası, tek dozluk kapta uzatılmış salımlı çözelti 50022500 Eye drops, prolonged-release solution in single-dose containerMedicinal product consisting of a prolonged-release eye drops solution presented in a single-dose container.

Göz damlası, toz ve çözücüsü 10606000 Eye drops, powder and solvent for solution Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of eye drops,

solution, by dissolving the powder in the solvent.

Göz içine uygulanan damlatma çözelti tozu ve çözücüsü 50047000 Powder and solvent for intraocular instillation solution Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of an intraocular

instillation solution by dissolving the powder in the solvent.

Hazır şırıngada implantasyon 50029750 Implant in pre-filled syringe Medicinal product consisting of an implant presented in a pre-filled syringe.

İğnesiz enjektörde enjeksiyonluk çözelti 50060150 Solution for injection in needle-free injector Medicinal product consisting of a solution for injection presented in a needle-free injector.

İmplantasyon matrisi için toz, çözücü ve matris 50055350 Powder, solvent and matrix for implantation matrix Sterile powder (including freeze-dried powder), sterile solvent and sterile matrix intended for the preparation of

an implantation matrix, for example by dissolving the powder in the solvent and using the resulting solution to

impregnate the matrix.

İmplantasyon patı için toz ve çözücü 11304000 Powder and solvent for implantation paste Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of an

implantation paste by dispersing the powder in the solvent.

İnfüzyonluk çözelti için konsantrelik toz ve çözelti 13062000 Powder for concentrate and solution for solution for infusion Medicinal product consisting of a powder for concentrate for solution for infusion and a solution for solution for

infusion, intended for the preparation of a solution for infusion.

İnfüzyonluk çözelti konsantre ve çözücüsü 50006000 Concentrate and solvent for solution for infusion Sterile concentrate and sterile solvent intended for the preparation of a solution for infusion by diluting the


İnfüzyonluk çözelti konsantresi tozu ve çözücüsü 50042000 Powder and solvent for concentrate for solution for infusionSterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a concentrate

fo solution for infusion by dissolving the powder in the solvent; the resulting concentrate for solution for

infusion must subsequently be diluted before administration as a solution for infusion.

İnfüzyonluk çözelti tozu ve çözücüsü 11214000 Powder and solvent for solution for infusion Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a solution for

infusion by dissolving the powder in the solvent.

İnfüzyonluk/enjeksiyonluk çözelti için çözücü ve konsantre 50007500 Concentrate and solvent for solution for injection/infusion Sterile concentrate and sterile solvent intended for the preparation of a solution for injection/infusion by

diluting the concentrate with the solvent.

İnfüzyonluk/enjeksiyonluk dispersiyon için gaz ve çözücü 50078000 Gas and solvent for dispersion for injection/infusionSterile gas and sterile solvent, either in the same compartment or in different compartments, intended for the

preparation of a dispersion for injection/infusion by dispersing the gas in the solvent.

İntravitreal implant uygulayıcı 50033500 Intravitreal implant in applicator Medicinal product consisting of an intravitreal implant presented in an applicator.

Kartuşta enjeksiyonluk çözelti 50060100 Solution for injection in cartridge Medicinal product consisting of a solution for injection presented in a cartridge.

Kartuşta enjeksiyonluk çözelti için toz ve çözücü 50048050 Powder and solvent for solution for injection in cartridge Medicinal product consisting of a powder and solvent for solution for injection presented in a cartridge. The

powder and solvent are contained in different compartments of the cartridge, which contains all of the


Kartuşta enjeksiyonluk süspansiyon 50063100 Suspension for injection in cartridge Medicinal product consisting of a suspension for injection presented in a cartridge.

Konsantre infüzyonluk çözelti konsantre ve çözücüsü 50002000 Concentrate and solvent for concentrate for solution for infusion Sterile concentrate and sterile solvent intended for the preparation of a concentrate for solution for infusion by

diluting the concentrate with the solvent; the resulting concentrate for solution for infusion must subsequently

be diluted again before administration as a solution for infusion.

Konsantre infüzyonluk dispersiyon için toz, dispersiyon ve çözücü 50048600 Powder, dispersion and solvent for concentrate for dispersion for infusionSterile powder (including freeze-dried powder) and sterile dispersion, both of which contain active substance(s),

and sterile solvent intended for the preparation of a concentrate for dispersion for infusion; it is prepared as

specified in the packaging information; the resulting concentrate for dispersion for infusion must subsequently

be diluted before administration as a dispersion for infusion.

Kullanıma hazır enjektörde enjeksiyonluk çözelti 13068000 Solution for injection in pre-filled injector Medicinal product consisting of a solution for injection presented in a pre-filled injector.

Kullanıma hazır enjektörde enjeksiyonluk süspansiyon 13064000 Suspension for injection in pre-filled injector Medicinal product consisting of a suspension for injection presented in a pre-filled injector.

Kullanıma hazır kalemde enjeksiyonluk çözelti 50060200 Solution for injection in pre-filled pen Medicinal product consisting of a solution for injection presented in a pre-filled pen.

Kullanıma hazır kalemde enjeksiyonluk çözelti için toz ve çözücü 50048150 Powder and solvent for solution for injection in pre-filled pen Medicinal product consisting of a powder and solvent for solution for injection presented in a pre-filled pen. The

powder and solvent are contained in different compartments of the pre-filled pen, which contains all of the


Kullanıma hazır kalemde enjeksiyonluk süspansiyon 50063200 Suspension for injection in pre-filled pen Medicinal product consisting of a suspension for injection presented in a pre-filled pen.

Kullanıma hazır kalemde enjeksiyonluk uzatılmış salımlı süspansiyon için toz ve çözücü50048010 Powder and solvent for prolonged-release suspension for injection in pre-filled penMedicinal product consisting of a powder and solvent for prolonged-release suspension for injection presented

in a pre-filled pen. The powder and solvent are contained in different compartments of the pre-filled pen, which

contains all of the components necessary to prepare the prolonged-release suspension for injection.

Kullanıma hazır şırıngada enjeksiyonluk çözelti 50060300 Solution for injection in pre-filled syringe Medicinal product consisting of a solution for injection presented in a pre-filled syringe.

Kullanıma hazır şırıngada enjeksiyonluk çözelti için toz ve çözücü 50048250 Powder and solvent for solution for injection in pre-filled syringe Medicinal product consisting of a powder and solvent for solution for injection presented in a pre-filled syringe.

The powder and solvent are contained in different compartments of the pre-filled syringe, which contains all of

the components necessary to prepare the solution for injection.

Kullanıma hazır şırıngada enjeksiyonluk süspansiyon 50063300 Suspension for injection in pre-filled syringe Medicinal product consisting of a suspension for injection presented in a pre-filled syringe.

Kullanıma hazır şırıngada enjeksiyonluk süspansiyon için çözelti ve süspansiyon 50056600 Solution and suspension for suspension for injection in pre-filled syringeMedicinal product consisting of a solution and suspension for suspension for injection presented in a pre-filled

syringe. The solution and suspension are contained in different compartments of the pre-filled syringe, which


Kullanıma hazır şırıngada enjeksiyonluk süspansiyon için toz ve çözücü 50048300 Powder and solvent for suspension for injection in pre-filled syringe Medicinal product consisting of a powder and solvent for suspension for injection presented in a pre-filled

syringe. The powder and solvent are contained in different compartments of the pre-filled syringe, which


Kullanıma hazır şırıngada enjeksiyonluk uzatılmış salımlı süspansiyon 50056250 Prolonged-release suspension for injection in pre-filled syringeMedicinal product consisting of a prolonged-release suspension for injection presented in a pre-filled syringe.

Kullanıma hazır şırıngada enjeksiyonluk uzatılmış salımlı süspansiyon için toz ve çözücü13057000 Powder and solvent for prolonged-release suspension for injection in pre-filled syringeMedicinal product consisting of a powder and solvent for prolonged-release suspension for injection presented

in a pre-filled syringe. The powder and solvent are contained in different compartments of the pre-filled syringe,

which contains all of the components necessary to prepare the prolonged-release suspension for injection.

Kullanıma hazır şırıngada enjeksiyonluk/infüzyonluk çözelti 50060500 Solution for injection/infusion in pre-filled syringe Medicinal product consisting of a solution for injection/infusion presented in a pre-filled syringe.

Kullanıma hazır şırıngada enjeksiyonluk/infüzyonluk emülsiyon 50021250 Emulsion for injection/infusion in pre-filled syringe Medicinal product consisting of an emulsion for injection/infusion presented in a pre-filled syringe.

Kullanıma hazır şırıngada infüzyonluk çözelti 50058500 Solution for infusion in pre-filled syringe Medicinal product consisting of a solution for infusion presented in a pre-filled syringe.

Radyofarmasötik ana çözeltisi 12105000 Radiopharmaceutical precursor A radionuclide produced for the radio-labelling of another substance prior to administration.

Radyofarmasötik hazırlamak için kit 12107000

Kit for radiopharmaceutical preparationA preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually prior

to its administration. The word radiopharmaceutical may be omitted if there is no ambiguity on the

radiopharmaceutical nature of the product. Combinations with other standard terms are not recommended.

Radyofarmasötik öncül, çözelti 50056500Radiopharmaceutical precursor, solution Liquid preparation consisting of a solution containing a radionuclide produced for the radio-labelling of another

substance prior to administration.

Tek dozluk kapta göz jeli 50023300 Eye gel in single-dose container Medicinal product consisting of an eye gel presented in a single-dose container.

Tek dozluk kapta göz merhemi 50023400 Eye ointment in single-dose container Medicinal product consisting of an eye ointment presented in a single-dose container.

Uygulama sisteminde enjeksiyonluk çözelti 13053000 Solution for injection in administration system Medicinal product consisting of a solution for injection presented in an administration system.

Uygulama sisteminde infüzyonluk çözelti 11210500 Solution for infusion in administration system Medicinal product consisting of a solution for infusion presented in an administration system.

Uygulama sisteminde infüzyonluk emülsiyon 13095000 Emulsion for infusion in administration system Medicinal product consisting of an emulsion for infusion presented in an administration system.

Uzatılmış salımlı enjeksiyonluk süspansiyon tozu ve çözücüsü 50048000 Powder and solvent for prolonged-release suspension for injection Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of a prolonged-

release suspension for injection by dispersing the powder in the solvent.

Yara çözeltisi için toz ve çözücü 50045500 Powder and solvent for epilesional solution Sterile powder (including freeze-dried powder) and sterile solvent intended for the preparation of an epilesional

solution by dissolving the powder in the solvent.

1.1.3 Seri Serbest Bırakma İşlemleri 1.1.3 Batch Certification

1.2 Steril Olmayan Ürünler 1.2 Non-sterile products 1.2.1 Steril Olmayan Ürünler 1.2.1 Non-sterile products

1.2.1.1 Sert Kapsüller 1.2.1.1 Capsules, hard shell

Değiştirilmiş salımlı sert kapsül 10217000

Modified-release capsule, hardSolid single-dose preparation consisting of a hard shell containing a solid or semi-solid formulation, showing a

rate, a place and/or a time of release different from that of a conventional-release capsule. This deliberate

modification is achieved by a special formulation design and/or manufacturing method. Hard modified-release

capsules are intended for oral use, and include prolonged-release, delayed-release and pulsatile-release

preparations. The generic term 'modified-release capsule, hard' is used only when the more specific terms

'gastro-resistant capsule, hard' or 'prolonged-release capsule, hard' do not apply.

Enterik sert kapsül 10212000

Gastro-resistant capsule, hard Solid single-dose, delayed-release preparation contained in a hard shell. The preparation is intended to resist the

gastric fluid and to release the active substance(s) in the intestinal fluid. Hard gastro-resistant capsules are

usually made by filling hard capsules with gastro-resistant granules or solid particles made gastro-resistant by

coating or, in certain cases, by providing hard capsules with a gastro-resistant shell. They are intended for oral

use.

İnhalasyon buharı, kapsül 11113000

Inhalation vapour, capsuleSolid preparation consisting of a capsule formulation intended for generation of vapour to be inhaled to obtain a

local effect. The vapour is usually generated by adding the whole capsule or the capsule contents to hot water.

Sert kapsül 10210000

Capsule, hardSolid single-dose preparation contained in a hard shell, the capacity of which can be varied. The shell is made of

gelatin or other substances. It consists of two prefabricated cylindrical sections one end of which is rounded and

closed, the other being open. The contents of the shell may be a solid or semi-solid preparation, which is filled

into one of the sections and closed by slipping the other section over it. Hard capsules are intended for oral use.

Uzatılmış salımlı sert kapsül 10215000

Prolonged-release capsule, hard Solid single-dose preparation consisting of a hard shell containing a solid or semi-solid formulation, showing a

slower release of the active substance(s) than that of a conventional-release capsule. Prolonged release is

achieved by a special formulation design and/or manufacturing method. Hard prolonged-release capsules are

intended for oral use.

Vajinal sert kapsül 10910000Vaginal capsule, hard Solid single-dose preparation consisting of a hard capsule of a size and shape suited for vaginal use, containing a

liquid or semi-solid formulation, intended for a local effect.

1.2.1.2 Yumuşak Kapsüller 1.2.1.2 Capsules, soft shell

Ağız mukoza kapsülü 10317000Oromucosal capsule Solid single-dose preparation contained in a soft shell to be chewed or sucked to obtain a local effect in the oral

cavity.

Çiğnenebilir kapsül, yumuşak 10214000

Chewable capsule, soft Solid single-dose preparation contained in a soft shell. The soft capsule is intended to be chewed to release its

contents into the mouth. The contents of the soft shell may be a semi-solid or liquid preparation intended for

local action or systemic delivery after absorption through the oral mucosa or, when swallowed, in the

gastrointestinal tract.

Değiştirilmiş salımlı yumuşak kapsül 10218000

Modified-release capsule, softSolid single-dose preparation consisting of a soft shell containing a semi-solid or liquid formulation, showing a

rate, a place and/or a time of release different from that of a conventional-release capsule. This deliberate

modification is achieved by a special formulation design and/or manufacturing method. Soft modified-release

capsules are intended for oral use, and include prolonged-release, delayed-release and pulsatile-release

preparations. The generic term 'modified-release capsule, soft' is used only when the more specific terms 'gastro-

resistant capsule, soft' or 'prolonged-release capsule, soft' do not apply.

Enterik yumuşak kapsül 10213000

Gastro-resistant capsule, softSolid single-dose, delayed-release preparation contained in a soft shell. The preparation is intended to resist the

gastric fluid and to release the active substance(s) in the intestinal fluid. Soft gastro-resistant capsules are

usually formed, filled and sealed in one operation. They may contain a liquid or semi-solid preparation in the

gastro-resistant shell. Soft gastro-resistant capsules are intended for oral use.

Rektal yumuşak kapsül 11014000Rectal capsule Solid single-dose preparation consisting of a soft capsule of elongated shape suitable for rectal use, containing a

liquid or semi-solid formulation, and which may have a lubricating coating.

Uzatılmış salımlı yumuşak kapsül 10216000

Prolonged-release capsule, soft Solid single-dose preparation consisting of a soft shell containing a semi-solid or liquid formulation, showing a

slower release of the active substance(s) than that of a conventional-release capsule. Prolonged release is

achieved by a special formulation design and/or manufacturing method. Soft prolonged-release capsules are

intended for oral use.

Vajinal yumuşak kapsül 10911000Vaginal capsule, soft Solid single-dose preparation consisting of a soft capsule of a size and shape suited for vaginal use, containing a

liquid or semi-solid formulation, intended for a local effect.

Yumuşak kapsül 10211000

Capsule, softSolid single-dose preparation contained in a soft shell, the capacity and shape of which can be varied. The shell is

made of gelatin or other substances and may contain (a) solid active substance(s). The shell is thicker than that

of hard capsules and consists of one part as soft capsules usually are formed, filled and sealed in one operation.

The contents of the shell may be a semi-solid or liquid preparation. Soft capsules are intended for oral use.

1.2.1.3 Tıbbi Sakızlar 1.2.1.3 Chewing gums

İlaçlı sakız 10229000

Medicated chewing-gum Solid single-dose preparation consisting of a basis, mainly composed of gums, intended to be chewed but not

swallowed. The active substance(s) is (are) released in saliva by chewing. Medicated chewing gum is intended for

local treatment of mouth diseases or systemic delivery after absorption through the oral mucosa or from the

gastrointestinal tract.

Oral sakız 10230000Oral gum Solid single-dose preparation with a gum-like consistency, intended to be sucked or chewed before being

swallowed. Medicated chewing gum is excluded.

1.2.1.4 Doyurulmuş Matrisler 1.2.1.4 Impregnated matrices

Emdirilmiş tıkaç 12117500

Impregnated plugSolid preparation consisting of a piece of material (e.g. polyethylene), usually porous, in which a liquid, semi-

solid or solid preparation is impregnated. Implants, pads, sponges and tampons are excluded.

İlaçlı iplik 12130000Medicated thread

Solid preparation consisting of a biodegradable or non-degradable thread impregnated with active substance(s).

İlaçlı kompres 10525000Impregnated dressing Solid preparation consisting of a piece or strip of gauze or other suitable fabric impregnated with a liquid or semi-

solid preparation intended for cutaneous use.

İlaçlı sünger 12119000Medicated sponge Solid preparation consisting of a sponge impregnated with active substance(s); different routes of administration

are possible.

İlaçlı tampon 12117000 Impregnated pad Solid preparation consisting of a piece of absorbent material impregnated with a liquid preparation.

İlaçlı vajinal tampon 10914000Medicated vaginal tampon Solid single-dose preparation consisting of a suitable material impregnated with active substance(s) intended to

be inserted in the vagina for a limited period of time.

İnhalasyon buharı, ilaçlı tampon 50033000Inhalation vapour, impregnated pad Solid preparation consisting of a piece of absorbent material impregnated usually with a liquid or semi-solid

preparation, intended for generation of vapour to be inhaled to obtain a local effect.

Kulak tamponu 10714000Ear tampon Solid single-dose preparation intended to be inserted into the external auditory meatus for a limited period of

time, consisting of a suitable material impregnated with active substance(s).

Rektal tampon 11015000Rectal tampon Solid single-dose preparation consisting of a suitable material impregnated with active substance(s) intended to

be inserted in the rectum for a limited period of time usually for a local effect.

Soluma buharı, emdirilmiş tıkaç 50033100

Inhalation vapour, impregnated plug Solid preparation consisting of an impregnated plug that generates a vapour to be inhaled, for example by the

patient inhaling through a device containing the plug, thereby drawing air through or over it and vaporising the

active ingredient(s) impregnated therein.

1.2.1.5 Haricî Kullanım İçin Likitler 1.2.1.5 Liquids for external useCilalar Lacquers

Diş cilası 12101000 Denture lacquer Liquid preparation to be applied to dentures to form a lacquer by evaporation of the volatile solvent.

İlaçlı tırnak cilası 10521000 Medicated nail lacquer Liquid preparation to be applied to the nails to form a lacquer by evaporation of the volatile solvent.


Aerosol inhalasyon, çözelti 11106000 Pressurised inhalation, solution

Liquid, usually multidose preparation consisting of a solution intended for inhalation use. The preparation is

presented in a pressurised container usually fitted with a metering dose valve.

Ağız mukoza çözeltisi 10305000 Oromucosal solution Liquid single-dose or multidose preparation consisting of a solution intended for oromucosal use.

Ağız mukoza spreyi için çözelti 10308200

Oromucosal spray, solution Liquid, usually multidose preparation consisting of a solution intended for oromucosal use. It is administered by

spraying into the oral cavity or onto a specific part of the oral cavity or the throat. It is presented in a container

with a spray pump or in a pressurised container with or without a metering valve. Sublingual sprays are

excluded.

Ağız mukozası/laringofarenjeal çözelti 50039500Oromucosal/laryngopharyngeal solution Liquid preparation consisting of a solution intended for oromucosal or laryngopharyngeal use.

'Oromucosal/laryngopharyngeal solution/spray, solution' is excluded.

Ağız mukozası/laringofarenjeal çözelti/sprey, çözelti 50040500Oromucosal/laryngopharyngeal solution/spray, solution Liquid preparation consisting of a solution intended for oromucosal or laryngopharyngeal use, presented in a

container with an optional spray device to allow administration as a spray.

Burun damlası, çözelti 10804000Nasal drops, solution Liquid single-dose or multidose preparation consisting of a solution intended for nasal use by means of a suitable

applicator.

Burun spreyi, çözelti 10808000

Nasal spray, solutionLiquid single-dose or multidose preparation consisting of a solution in a container with or without a metering

dose valve or in a container with a spray pump or equivalent device to create a spray, intended for nasal use.

Burun spreyi, çözelti/ağız mukozası çözeltisi 50037400Nasal spray, solution/oromucosal solution

Liquid preparation consisting of a solution intended for use as a nasal spray or an oromucosal solution.

Burun yıkama çözeltisi 10811000Nasal wash Liquid single-dose or multidose preparation consisting of usually an aqueous isotonic solution intended for

cleansing the nasal cavities.

Burun/ağız mukoza spreyi, çözelti 50036700Nasal/oromucosal spray, solution Liquid preparation consisting of a solution in a container with or without a metering dose valve or in a container

with a spray pump, intended for nasal or oromucosal use.

Burun/ağız mukozası çözeltisi 50036500Nasal/oromucosal solution Liquid preparation consisting of a solution intended for nasal or oromucosal application. 'Nasal/oromucosal

spray, solution' and 'Nasal spray, solution/oromucosal solution' are excluded.

Deri çözeltisi 10513000Cutaneous solution Liquid, usually multidose preparation consisting of a solution of the active substance in a suitable vehicle

intended for cutaneous use.

Deri çözeltisi/konsantre ağız mukoza çözeltisi 50015450Cutaneous solution/concentrate for oromucosal solution Liquid preparation consisting of a solution intended for cutaneous use or intended to be diluted in the specified

liquid to obtain an oromucosal solution.

Deri spreyi çözelti 10509000Cutaneous spray, solution Liquid preparation, usually multidose, consisting of a solution in a pressurised container with a spray valve or in a

container equipped with a spray pump, intended for cutaneous use.

Dilaltı sprey, çözelti 10309200Sublingual spray, solution Liquid, usually multidose preparation consisting of a solution intended for sublingual use. Sublingual sprays are

usually presented in pressurised containers with a metering valve.

Diş çözeltisi 10406000Dental solution

Liquid, usually multidose preparation consisting of a solution intended for administration on teeth and gums.

Diş dolgu maddesi için çözelti 10414000 Solution for dental cement Liquid preparation consisting of a solution intended for use in the preparation of a dental cement.

Dişeti çözeltisi 10312000 Gingival solution Liquid, usually multidose preparation consisting of a solution intended for gingival use.

Endotrakeopulmoner damlatma çözeltisi 11601000Endotracheopulmonary instillation, solution Liquid preparation consisting of an aqueous solution intended for instillation to the trachea and/or bronchea.

Preparations for inhalation use are excluded.

Gargara 10301000 Gargara

Gargara / ağız yıkama suyu 50024000 Gargle/mouthwash Liquid preparation consisting of a solution intended for use as a gargle or a mouthwash.

Gargara/burun yıkama 50024500 Gargle/nasal wash Liquid preparation consisting of a solution intended for use as a gargle or a nasal wash.

İnhalasyon buharı, çözelti 11114000Inhalation vapour, solution Liquid preparation consisting of a solution intended for generation of vapour to be inhaled to obtain a local

effect. The vapour is usually generated by adding the solution to hot water.

İyontoforez çözeltisi 10518000Solution for iontophoresis Liquid preparation consisting of an aqueous solution intended for transdermal delivery by means of

iontophoresis.

Kulak damlası, çözelti 10704000

Ear drops, solution Liquid single-dose or multidose preparation consisting of an aqueous or oily solution intended for application to

the external auditory meatus. Multidose containers may be dropper containers or containers provided with a

dropper applicator, or the dropper may be supplied separately. Drops are not necessarily administered

dropwise, but may also be administered as a small volume.

Kulak spreyi, çözelti 10709000

Ear spray, solution Liquid, usually multidose preparation consisting of a solution intended for application to the external auditory

meatus by spraying to obtain a local effect. Ear sprays are presented in containers with a spray pump or in

pressurised containers fitted with a spray valve.

Kulak yıkama çözeltisi 10712000Ear wash, solution Liquid single-dose or multidose preparation consisting usually of an aqueous solution with a pH within

physiological limits. Ear washes are intended to clean the external auditory meatus.

Laringofarenjeal çözelti 13016000Laryngopharyngeal solution Liquid preparation consisting of a solution intended for administration to the laryngopharynx for a local effect,

other than by spraying.

Laringofarenjeal sprey, çözelti 13017000Laryngopharyngeal spray, solution

Liquid preparation consisting of a solution intended for spraying onto the laryngopharynx for a local effect.

Nebulizasyon çözeltisi 11101000Nebuliser solution Liquid preparation consisting of a solution intended for inhalation use. The solution is converted into an aerosol

by a continuously operating nebuliser or a metered-dose nebuliser.

Provokasyon testi için çözelti 12131000Solution for provocation test Liquid preparation consisting of a solution containing an allergen intended for provocation testing by the nasal,

ocular or bronchial routes.

Rektal çözelti 11005000

Rectal solution Liquid preparation consisting of a solution intended for rectal use or for diagnostic purposes. Rectal solutions are

usually presented in containers with a volume in the range of 2.5 mL to 2000 mL. The container is fitted with an

applicator or an applicator is provided separately.

Sinüsiçi çözelti 13041000Endosinusial solution

Liquid preparation consisting of a solution intended to be administered to the sinuses to obtain a local effect.

Soluma çözeltisi 50081000

Inhalation solution Liquid, usually multidose preparation consisting of a solution intended for inhalation use. The preparation is

presented in a non-pressurised container fitted with a metering dose mechanism. 'Nebuliser solution' and

'Pressurised inhalation, solution' are excluded.

Transdermal çözelti 10546400

Transdermal solution Liquid single-dose or multidose preparation consisting of a solution intended for transdermal use. The term

'Transdermal solution' is used only when more-specific terms such as 'Pour-on solution', 'Solution for

iontophoresis', 'Spot-on solution' and 'Transdermal spray, solution' do not apply.

Transdermal sprey, çözelti 10546500Transdermal spray, solution Liquid, usually multidose preparation consisting of a solution in a pressurised container with a spray valve or a

container equipped with a spray pump, intended for transdermal use.

Vajinal çözelti 10905000Vaginal solution Liquid preparation consisting of a solution intended for vaginal use by means of a suitable applicator in order to

obtain a local effect.

Damlalar Drops

Ağız mukoza damlası 10307000

Oromucosal drops Liquid, usually multidose preparation consisting of a solution, suspension or emulsion intended for oromucosal

use. Oromucosal drops are administered by instillation into the oral cavity or onto a specific part of the oral

cavity.


Ağız mukozası çözeltisi için konsantre 13003000 Concentrate for oromucosal solution Liquid preparation intended to be diluted in the specified liquid to obtain an oromucosal solution.

Deri çözeltisi için konsantre 10514000 Concentrate for cutaneous solution Liquid preparation intended to be diluted in the specified liquid to obtain a cutaneous solution.

Deri spreyi için konsantre, emülsiyon 50009000Concentrate for cutaneous spray, emulsion

Liquid preparation intended to be diluted in the specified liquid to obtain a cutaneous spray emulsion.

Gargara için konsantre 10302000Concentrate for gargle

Liquid preparation consisting of an aqueous solution intended to be diluted in water to obtain a gargle.

Nebülizer çözelti için konsantre 13002000 Concentrate for nebuliser solution Liquid preparation intended to be diluted in the specified liquid to obtain a nebuliser solution.

Rektal çözelti için konsantre 11008000 Concentrate for rectal solution Liquid preparation intended to be diluted in the specified liquid to obtain a rectal solution.


Aerosol inhalasyon, emülsiyon 11108000Pressurised inhalation, emulsion Liquid, usually multidose preparation consisting of an emulsion intended for inhalation use The preparation is

presented in a pressurised container fitted with a metering dose valve.

Ağız mukozası spreyi, emülsiyon 10308100

Oromucosal spray, emulsion Liquid, usually multidose preparation consisting of an emulsion intended for oromucosal use. It is administered

by spraying into the oral cavity or onto a specific part of the oral cavity or the throat. It is presented in a

container with a spray pump or in a pressurised container with or without a metering valve. Sublingual sprays

are excluded.

Burun damlası, emülsiyon 10806000Nasal drops, emulsion Liquid single-dose or multidose preparation consisting of an emulsion intended for nasal use by means of a

suitable applicator.

Burun spreyi, emülsiyon 10810000

Nasal spray, emulsionLiquid single-dose or multidose preparation consisting of an emulsion in a container with or without a metering


Deri emülsiyonu 10516000 Cutaneous emulsion Liquid, usually multidose preparation consisting of an emulsion intended for cutaneous use.

Deri spreyi, emülsiyon 50015500Cutaneous spray, emulsion Liquid preparation, usually multidose, consisting of an emulsion in a pressurised container with a spray valve or

in a container equipped with a spray pump, intended for cutaneous use.

Dilaltı sprey, emülsiyon 10309100Sublingual spray, emulsion Liquid, usually multidose preparation consisting of an emulsion intended for sublingual use. Sublingual sprays are

usually presented in pressurised containers with a metering valve.

Diş emülsiyonu 10408000Dental emulsion Liquid, usually multidose preparation consisting of an emulsion intended for administration on to the teeth and

the gums.

İnhalasyon buharı, emülsiyon 50032000Inhalation vapour, emulsion Liquid preparation consisting of an emulsion intended for generation of vapour to be inhaled to obtain a local

effect. The vapour may be generated by adding the emulsion to hot water.

Kulak damlası, emülsiyon 10706000

Ear drops, emulsion Liquid single-dose or multidose preparation consisting of an emulsion intended for application to the external

auditory meatus. Multidose containers may be dropper containers or containers provided with a dropper

applicator, or the dropper may be supplied separately. Drops are not necessarily administered dropwise, but

may also be administered as a small volume.

Kulak spreyi, emülsiyon 10711000

Ear spray, emulsion Liquid, usually multidose preparation consisting of an emulsion intended for application to the external auditory

meatus by spraying to obtain local effect. Ear sprays are presented in containers with a spray pump or in


Kulak yıkama emülsiyonu 10713000Ear wash, emulsion Liquid single-dose or multidose preparation consisting usually of an oil-in-water emulsion with a pH within

physiological limits. Ear washes are intended to clean the external auditory meatus.

Nebulizör ile inhalasyon emülsiyonu 11105000

Nebuliser emulsionLiquid preparation consisting of an emulsion intended for inhalation to obtain local effect or systemic delivery.

The emulsion is converted into an aerosol by a continuously operating nebuliser or a metered-dose nebuliser.

Rektal emülsiyon 11007000

Rectal emulsion Liquid preparation consisting of an emulsion intended for rectal use or for diagnostic purposes. Rectal emulsions

are usually presented in containers with a volume in the range of 2.5 mL to 2000 mL. The container is fitted with

an applicator or an applicator is provided separately.



Vajinal emülsiyon 10907000Vaginal emulsion Liquid preparation consisting of an emulsion intended for vaginal use by means of a suitable applicator in order

to obtain a local effect.

Kollodionlar Collodions

Kollodion 10520000Collodion Liquid preparation usually containing pyroxylin in a mixture of ether and ethanol. When applied to the skin, the

preparation forms a flexible film on the site of application.

Sıvılar Liquids

Ağız çalkalama sıvısı 10310000Gargle Liquid preparation consisting of an aqueous solution intended for gargling to obtain a local effect in the oral

cavity and the throat. Gargles are not to be swallowed.

Deriye uygulanan sıvı 10512000Cutaneous liquid

Liquid, usually multidose preparation consisting of a liquid active substance per se, intended for cutaneous use.

İnhalasyon buharı, sıvı 11117000

Inhalation vapour, liquid Liquid preparation consisting of a liquid active substance per se, such as an essential oil or a volatile anaesthetic,

intended for generation of vapour to be inhaled. The vapour may be generated by adding the liquid to hot water

or by the use of a vaporising device.


Aerosol inhalasyon ,süspansiyon 11107000Pressurised inhalation, suspension Liquid, usually multidose preparation consisting of a suspension intended for inhalation use. The preparation is

presented in a pressurised container fitted with a metering dose valve.

Deri spreyi, süspansiyonu 10510000Cutaneous spray, suspension Liquid, usually multidose preparation consisting of a suspension in a pressurised container with a spray valve or

in a container equipped with a spray pump, intended for cutaneous use.

Deri süspansiyonu 10515000Cutaneous suspension Liquid, usually multidose preparation consisting of a suspension of fine particles in a suitable vehicle intended for

cutaneous use.

Dilaltı spreyi, süspansiyon 10309300Sublingual spray, suspension Liquid, usually multidose preparation consisting of a suspension intended for sublingual use. Sublingual sprays

are usually presented in pressurised containers with a metering valve.

Diş süspansiyonu 10407000Dental suspension

Liquid, usually multidose preparation consisting of a suspension intended for administration on teeth and gums.

Endotrakeopulmoner damlatma süspansiyonu 11603000Endotracheopulmonary instillation, suspension Liquid preparation consisting of an aqueous suspension intended for instillation to the trachea and/or bronchea.

Preparations for inhalation use are excluded.

Kulak damlası, süspansiyon 10705000

Ear drops, suspension Liquid single-dose or multidose preparation consisting of an aqueous or oily suspension intended for application

to the external auditory meatus. Multidose containers may be dropper containers or containers provided with a

dropper applicator, or the dropper may be supplied separately. Drops are not necessarily administered

dropwise, but may also be administered as a small volume.

Kulak spreyi, süspansiyon 10710000

Ear spray, suspension Liquid, usually multidose preparation consisting of a suspension intended for application to the external auditory

meatus by spraying to obtain a local effect. Ear sprays are presented in containers with a spray pump or in


Nebulizör ile inhalasyon süspansiyonu 11102000 Nebuliser suspension

Liquid preparation consisting of a suspension intended for inhalation use. The suspension is converted into an

aerosol by a continuously operating nebuliser or a metered-dose nebuliser.

Ağız mukoza süspansiyonu 10306000Oromucosal suspension

Liquid single-dose or multidose preparation consisting of a suspension intended for oromucosal use.

Burun damlası, süspansiyon 10805000Nasal drops, suspension Liquid single-dose or multidose preparation consisting of a suspension intended for nasal use by means of a

suitable applicator.

Burun spreyi, süspansiyon 10809000

Nasal spray, suspensionLiquid single-dose or multidose preparation consisting of a suspension in a container with or without a metering


Sinüs içi yıkama, süspansiyon 50022000 Endosinusial wash, suspension Liquid preparation consisting of a suspension intended for cleaning the sinuses.

Kulak/burun damlası, süspansiyon 50020200 Ear/nasal drops, suspension Liquid preparation consisting of a suspension intended for use as ear drops or nasal drops.

Ağız mukozası spreyi için süspansiyon 10308300

Oromucosal spray, suspensionLiquid, usually multidose preparation consisting of a suspension intended for oromucosal use. It is administered

by spraying into the oral cavity or onto a specific part of the oral cavity or the throat. It is presented in a

container with a spray pump or in a pressurised container with or without a metering valve.

Rektal süspansiyon 11006000

Rectal suspension Liquid preparation consisting of a suspension intended for rectal use or for diagnostic purposes. Rectal

suspension are usually presented in containers with a volume in the range of 2.5 mL to 2000 mL. The container is

fitted with an applicator or an applicator is provided separately.

Vajinal süspansiyon 10906000Vaginal suspension Liquid preparation consisting of a suspension intended for vaginal use by means of a suitable applicator in order

to obtain a local effect.

Şampuanlar Shampoos

Şampuan 10508000

ShampooLiquid or, occasionally, semi-solid, usually multidose preparation intended for application to the scalp by rubbing

and subsequent washing away with water. Upon rubbing with water, shampoos usually form foam. Shampoos

are solutions, suspensions or emulsions containing surface-active agents.

Banyo katığı 10501000 Bath additive Solid, semi-solid or liquid preparation to be added to the bath water.

1.2.1.6 Dâhilî Kullanım İçin Likitler 1.2.1.6 Liquids for internal useÇözeltiler Solutions

Ağızdan/rektal çözelti 50037900 Oral/rectal solution Liquid preparation consisting of a solution intended for oral or rectal use.

Mide-bağırsak çözeltisi 12108000Gastroenteral solution Liquid preparation consisting of a solution intended for administration to the stomach or duodenum by means of

a suitable applicator.

Oral çözelti 10105000

Oral solution Liquid single-dose or multidose preparation consisting of a solution intended for oral use. Each dose from a

multidose container is administered by means of a device suitable for measuring the prescribed volume,

generally 5 mL or multiples thereof.

Oral çözelti/nebülizer çözelti için konsantre 50038500Oral solution/concentrate for nebuliser solution Liquid preparation consisting of a solution intended for oral use or intended to be diluted in the specified liquid

to obtain a nebuliser solution.

Oral damla çözelti 10101000

Oral drops, solution Liquid, usually multidose preparation consisting of a solution intended for oral use. The preparation is

administered in small volumes by means of a suitable measuring device such as a dropper, pipette or oral

syringe capable of accurate dosing of the solution. The measured dose may be diluted in water or another

suitable liquid before swallowing.


Ağızdan/makattan çözelti için konsantre 50011000 Concentrate for oral/rectal solution Liquid preparation intended to be diluted in the specified liquid to obtain an oral/rectal solution.

Konsantre oral sprey için konsantre, süspansiyon13085000

konsantre oral sprey için konsantre, süspansiyonConcentrate for concentrate for oral spray, suspension: konsantre ağızdan püskürtücü için konsantre, katı asıltı

Oral çözelti için konsantre 50010000 Concentrate for oral solution Liquid preparation intended to be diluted in the specified liquid to obtain an oral solution.

Oral süspansiyon için konsantre 10100500 Concentrate for oral suspension Liquid preparation intended to be diluted in the specified liquid to obtain an oral suspension.


Mide-bağırsak emülsiyonu 12111000Gastroenteral emulsion Liquid preparation consisting of an emulsion intended for administration to the stomach or duodenum by means

of a suitable applicator.

Oral damla, emülsiyon 10103000

Oral drops, emulsion Liquid, usually multidose preparation consisting of an emulsion intended for oral use. The preparation is


syringe capable of accurate dosing of the emulsion. The measured dose may be diluted in water or another


Oral emulsion 10107000

Oral emulsion Liquid single-dose or multidose preparation consisting of an emulsion intended for oral use. Each dose from a



Sıvılar Liquids

Ağız damlası, sıvı 50037750

Oral drops, liquid Liquid, usually multidose preparation consisting of a liquid active substance per se, intended for oral use. The

preparation is administered in small volumes by means of a suitable measuring device such as a dropper, pipette

or oral syringe capable of accurate dosing of the liquid. The measured dose may be diluted in water or another


Oral sıvı 10104000

Oral sıvıLiquid single-dose or multidose preparation consisting of a liquid active substance per se, intended for oral use.

Each dose from a multidose container is administered by means of a suitable device such as a measuring spoon.


Mide-bağırsak süspansiyonu 12110000Gastroenteral suspension Liquid preparation consisting of a suspension intended for administration to the stomach or duodenum by

means of a suitable applicator.

Oral / rektal süspansiyon 50038000 Oral/rectal suspension Liquid preparation consisting of a suspension intended for oral or rectal use.

Oral damla süspansiyon 10102000

Oral drops, suspension Liquid, usually multidose preparation consisting of a suspension intended for oral use. The preparation is


syringe capable of accurate dosing of the suspension. The measured dose may be diluted in water or another


Oral süspansiyon 10106000

Oral suspension Liquid single-dose or multidose preparation consisting of a suspension intended for oral use. Each dose from a



Oral süspansiyon için süspansiyon 13037000Suspension for oral suspension

Liquid preparation consisting of a suspension intended for use in the preparation of an oral suspension.

Şuruplar Syrups

Şurup 10117000

Syrup Liquid single-dose or multidose aqueous preparation characterised by a sweet taste and a viscous consistency

and usually containing aromatic or other flavouring agents, intended for oral use. Each dose from a multidose

container is administered by means of a device suitable for measuring the prescribed volume, generally 5 mL or

multiples thereof.

1.2.1.7 Medikal Gazlar 1.2.1.7 Medicinal gasesAzot Nitrogen

Azot Protoksit Nitrous oxide

Karbondioksit Carbon dioxide

Kuru Hava Medicinal air

Nitrik Oksit Nitric oxide

Oksijen Oxygen

Sıvı Azot Liquefied oxygen

Sıvı Oksijen Liquefied oxygen

Kriyojenik tıbbi gaz 12302000 Medicinal gas, cryogenic a gas which liquifies at 1.013 bar at a temperature below -150 °C.

Sıkıştırılmış tıbbi gaz 12301000 Medicinal gas, compressed A gas packaged under pressure which is entirely gaseous at - 50

Sıvılaştırılmış tıbbi gaz 12303000 Medicinal gas, liquefied A gas packaged under pressure, which is partially liquid (gas over liquid) at -50 °C.

1.2.1.8 Diğer Katı Dozaj Şekilleri 1.2.1.8 Other solid dosage forms

Çaylar Tea

Bitkisel çay 10122000

Herbal tea Solid preparation consisting exclusively of one or more herbal drugs intended for the preparation of an oral

aqueous preparation by means of decoction, infusion or maceration. Herbal teas are usually presented in bulk

form or in bags. The tea is prepared immediately before oral intake.

Çözünebilir granüle-toz bitkisel çay 10202000Instant herbal tea Solid preparation consisting of a lyophilised herbal drug extract intended to be dissolved in water before oral

use. Instant herbal teas are supplied in bulk form (multidose) or in sachets (single-dose).

Çubuklar Sticks

Burun çubuğu 10812000Nasal stick

Solid single-dose preparation, usually rod-shaped or conical, intended for nasal use to obtain a local effect.

Deriye uygulama çubuğu 10523000

Cutaneous stickSolid preparation, usually rod-shaped or conical, intended for application to the skin to obtain a local effect.

Cutaneous sticks may consist of the active substance(s) alone or dissolved or dispersed in a suitable basis.

Diş çubuğu 10403000Dental stick Solid single-dose preparation, rod-shaped and usually prepared by compression or moulding, intended for dental

use.

Kulak çubuğu 10715000Ear stick Solid single-dose preparation of usually conical shape intended to be inserted in the external auditory meatus

where it melts or dissolves.

Filmler Films

Ağızda dağılan film 10236100Orodispersible film Solid preparation consisting of a single- or multilayer sheet of suitable material(s) intended to be placed in the

mouth where it disperses rapidly before being swallowed.

Dilaltı film 10317500Sublingual film Solid preparation consisting of a single- or multilayer sheet of suitable material(s) intended for sublingual use to

obtain a systemic effect.

Yanakiçi film 10314011Buccal film Solid preparation consisting of a single- or multilayer sheet of suitable material(s) intended to be applied to the

buccal cavity (pouch) to obtain a systemic effect.

Flasterler Plasters

İlaçlı flaster 10506000

Medicated plaster Flexible single-dose preparation intended to be applied to the skin to obtain, usually, a local effect. Medicated

plasters consist of an adhesive basis containing the active substance and spread as a uniform layer on an

appropriate support made of natural or synthetic material. The adhesive layer is covered by a suitable protective

liner, which is removed before applying the plaster to the skin. Medicated plasters are presented in a range of

sizes or as larger sheets to be cut before use.

Provokasyon testi için flaster 10550000Plaster for provocation test Solid flexible preparation containing an allergen product intended for provocation testing by application to the

skin.

Granüller Granules

Ağız damlası, çözeltilik granül 50037500Oral drops, granules for solution Solid preparation consisting of granules intended to be dissolved in the specified liquid to obtain an oral drops

solution.

Ağızdan süspansiyon için efervesan granül 13007000

Effervescent granules for oral suspension Solid preparation consisting of effervescent granules intended to be dispersed or dissolved in the specified

liquid, which is supplied in the same packaging, to obtain an oral suspension. Where the granules are intended to

be dispersed in water, the term 'Effervescent granules' is used instead.

Ağızdan/makattan süspansiyon için granül 50029150Granules for oral/rectal suspension Solid preparation consisting of granules intended to be dispersed in the specified liquid to obtain an oral/rectal

suspension.

Değiştirilmiş salımlı granül 10208000

Modified-release granules Solid preparation consisting of granules showing a rate and/or place of release different from that of

conventional-release granules. This deliberate modification is achieved by a special formulation design and/or

manufacturing method. Modified-release granules are usually single-dose preparations intended for oral use,

and include prolonged-release, delayed release and pulsatile-release granules. The generic term 'modified-

release granules' is used only when the more specific terms 'gastro-resistant granules' or 'prolonged-release

granules' do not apply.

Değiştirilmiş salımlı oral süspansiyon granülü 50036000Modified-release granules for oral suspension Solid preparation consisting of modified-release granules intended to be dispersed in the specified liquid to

obtain an oral suspension.

Efervesan granül 10205000

Effervescent granulesSolid single-dose or multidose preparation consisting of uncoated granules generally containing acidic

substances and carbonates or hydrogen carbonates that rapidly react in the presence of water to release carbon

dioxide. Effervescent granules are intended to be dissolved or dispersed in water before oral use.

Enterik granül 10206000

Gastro-resistant granulesSolid preparation consisting of delayed-release granules intended to resist the gastric fluid and release the active

substance(s) in the intestinal fluid. This deliberate modification is achieved by coating the granules with a gastro-

resistant material or by embedding the solid particles in the gastro-resistant material. Gastro-resistant granules

are usually single-dose preparations intended for oral use.

Granül 10204000

GranulesSolid single-dose or multidose preparation consisting of solid, dry aggregates of powder particles that are

sufficiently resistant to withstand handling. Granules are intended for oral use to release active substance(s) in

the gastrointestinal fluids by a rate depending essentially on the intrinsic properties of the active substance(s)

(conventional release). They may be swallowed as such and/or chewed before swallowing, and some may also

be dissolved or dispersed in water or another suitable liquid before oral administration. Granules for oral

solution and Granules for oral suspension are excluded.

Kaplı granül 13046000

Coated granulesSolid preparation intended for oral use, consisting of granules coated with one or more layers of mixtures of

various substances that are usually applied as a solution or suspension in conditions in which evaporation of the

vehicle occurs. When the coating dissolves or disintegrates any active substance is released into the

gastrointestinal fluid at a rate depending essentially on its intrinsic properties (conventional release).

Oral çözelti granülü 10112000

Granules for oral solution Solid preparation consisting of aggregated particles that may include excipients to facilitate wetting and

dissolution, intended to be dissolved in the specified liquid to obtain an oral solution, which is usually prepared

just before administration to the patient.

Oral süspansiyon granülü 10113000

Granules for oral suspension Solid preparation consisting of aggregated particles that may include excipients to facilitate wetting and

dispersion, intended to be dispersed in the specified liquid to obtain an oral suspension, which is usually

prepared just before administration to the patient

Oral süspansiyonluk enterik granül 50026000Gastro-resistant granules for oral suspension Solid preparation consisting of gastro-resistant granules intended to be dispersed in the specified liquid to obtain

an oral suspension.

Rektal süspansiyon için granül 13015000

Granules for rectal suspension Solid preparation consisting of aggregated particles that may include excipients to facilitate wetting and

dispersion, intended to be dispersed in the specified liquid to obtain a rectal suspension, which is usually

prepared just before administration to the patient.

Şurup icin granül 10119000

Granules for syrupSolid preparation consisting of aggregated particles that may include excipients to facilitate wetting and

dissolution and to obtain the characteristics of a syrup, intended to be dissolved in water to obtain a syrup.

Uzatılmış salımlı granül 10207000

Prolonged-release granulesSolid preparation consisting of granules showing a slower release than that of conventional-release granules.

This deliberate modification is achieved by a special formulation design and/or manufacturing method.

Prolonged-release granules are usually single-dose preparations intended for oral use.

Uzatılmış salımlı oral süspansiyonluk granül 50056000Prolonged-release granules for oral suspension Solid preparation consisting of prolonged-release granules intended to be dispersed in the specified liquid to

obtain an oral suspension.

Vajinal çözelti için granül 50029500

Granules for vaginal solution Solid preparation consisting of aggregated particles that may include excipients to facilitate wetting and

dissolution, intended to be dissolved in the specified liquid to obtain a vaginal solution, which is usually prepared

just before administration to the patient.

İnsertler Insert

Periodontal insert 10411000

Periodontal insertSolid single-dose preparation consisting of a medicated insert to be placed within the tooth socket/periodontal

membrane. The biodegradable insert is a sheet which slowly releases active substance(s).

Kaşeler Cachets

Kaşe 10209000 Cachet Solid discoid preparation consisting of a wafer enclosing a unit dose intended for oral use.

Liyofilizatlar Lyophilisates

Oral liyofilizat 10224000

Oral lyophilisate Solid single-dose preparation made by freeze-drying of a liquid or semi-solid preparation. This fast-releasing

preparation is intended to be placed in the mouth where its contents are released in saliva and swallowed or,

alternatively, to be dissolved in water before oral administration.

Pastiller Pastilles

Pastil 10321000/ 10323000

Lozenge/PastilleLozenge: Solid single-dose preparation intended to be sucked to obtain, usually, a local effect in the oral cavity

and the throat. Lozenges are hard preparations prepared by moulding. They usually contain flavouring and

sweetening agents. Lozenges dissolve or disintegrate slowly when sucked.

Pastille: Solid single-dose preparation intended to be sucked to obtain, usually, a local effect in the oral cavity

and the throat. Pastilles are soft, flexible preparations prepared by moulding of mixtures containing natural or

synthetic polymers or gums and sweeteners. They dissolve or disintegrate slowly when sucked.

Tablet pastil 10322000

Compressed lozenge Solid single-dose preparation intended to be sucked to obtain a local or systemic effect. It is prepared by

compression and is often rhomboid in shape. Compressed lozenges usually contain flavouring and sweetening

agents. They dissolve or disintegrate slowly when sucked.

Pilüller Pillules

Pilül 10231000

Pillules Solid preparation for homoeopathic use, obtained from sucrose, lactose or other suitable excipients. Pillules

may be prepared by impregnation of preformed pillules with a dilution or dilutions of homoeopathic stocks or by

progressive addition of these excipients and the addition of a dilution or dilutions of homoeopathic stocks.

Pillules are intended for oral or sublingual

Tozlar Powders

Ağız damlası, süspansiyonluk toz 50082000Oral drops, powder for suspension Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed

in the specified liquid to obtain an oral drops suspension.

Ağız yıkama, çözeltilik toz 50036050Mouthwash, powder for solution Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved

in the specified liquid to obtain a mouthwash.

Rahim ağız kanalı jeli için toz 13024000 Powder for endocervical gel Solid preparation consisting of one or more powders intended to be mixed with the specified liquid or gel to

obtain an endocervical gel.

Burun damlası, çözeltilik toz 13020000Nasal drops, powder for solution Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved

in the specified liquid to obtain a nasal drops solution.

Burun tozu 10807000Nasal powder Solid, usually multidose preparation consisting of one or more powders of solid active substance(s) intended for

nasal use by insufflation into the nasal cavity.

Buruna püskürtücü, çözeltilik toz 50037100Nasal spray, powder for solution Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved

in the specified liquid to obtain a nasal spray solution.

Deri çözeltisi için toz 10514500Powder for cutaneous solution Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved

in the specified liquid to obtain a cutaneous solution.

Deri spreyi, toz 10511000Cutaneous spray, powder Solid, usually multidose preparation presented in a pressurised container with a spray valve or in a container

equipped with a spray pump. The spray is intended for cutaneous use.

Deri tozu 10517000Cutaneous powder Solid, usually multidose preparation consisting of a powder intended for cutaneous use. Cutaneous spray,

powder is excluded.

Dilaltı toz 13105000 Sublingual powder Solid preparation consisting of a powder intended for sublingual use.

Diş çözeltisi için toz 50049270Powder for dental solution Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved

in the specified liquid to obtain a dental solution.

Diş dolgu maddesi için toz 10413000Powder for dental cement Solid preparation consisting of one or more powders, including freeze-dried powders, intended for use in the

preparation of a dental cement.

Diş jeli için toz 13022000Powder for dental gel Solid preparation consisting of one or more powders intended to be mixed with the specified liquid or gel to

obtain a dental gel.

Diş tozu 10405000 Dental powder Solid preparation consisting of one or more powders intended for administration on teeth and gums.

Dişeti jeli için toz 13026000Powder for gingival gel Solid preparation consisting of one or more powders intended to be mixed with the specified liquid or gel to

obtain a gingival gel.

Efervesan toz 10203000

Effervescent powderSolid single-dose or multidose preparation consisting of one or more powders generally containing acid

substances and carbonates or hydrogen carbonates that react rapidly in the presence of water to release carbon

dioxide. Effervescent powders are intended to be dissolved or dispersed in water before administration.

Endotrakeopulmoner damlatma çözeltisi tozu 11602000 Endotracheopulmonary instillation, powder for solution Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved

in the specified liquid to obtain an endotracheopulmonary instillation solution.

Endotrakeopulmoner süspansiyonluk için damlatma, toz 13009000Endotracheopulmonary instillation, powder for suspension Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed

in the specified liquid to obtain an endotracheopulmonary instillation suspension.

Gargara, çözelti tozu 10303000Gargle, powder for solution

Solid preparation consisting of one or more powders intended to be dissolved in water to obtain a gargle.

İnhalasyon buharı, toz 11112000

Inhalation vapour, powderSolid preparation consisting of one or more powders of solid active substance(s) intended for generation of

vapour to be inhaled to obtain a local effect. The vapour is usually generated by adding the powder to hot water.

İnhalasyon için toz 11109000

Inhalation powderSolid, usually multidose preparation intended for inhalation use, consisting of one or more powders of solid

active substance(s) to be administered by a dry-powder inhaler containing a metering dose mechanism within

the inhaler. 'Inhalation powder, hard capsule' and 'Inhalation powder, pre-dispensed' are excluded.

İyontoforez için çözeltilik toz 10518500Powder for solution for iontophoresis Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved

in the specified liquid to obtain a solution for iontophoresis.

Jel için toz 13021000Powder for gel Solid preparation consisting of one or more powders intended to be mixed with the specified liquid or gel to

obtain a gel (for cutaneous use).

Kulak damlası, süspansiyonluk toz 13006000Ear drops, powder for suspension Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed

in the specified liquid to obtain an ear drops suspension.

Kulak tozu 10708000

Ear powder Solid, usually multidose preparation consisting of one or more powders consisting of (a) solid active substance(s)

intended for application to the external auditory meatus. Ear powders are presented in containers fitted with a

suitable applicator or device for insufflation.

Nebulizör çözeltisi için toz 11104000Powder for nebuliser solution Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved

in the specified liquid to obtain a nebuliser solution.

Nebulizör süspansiyonu için toz 11103000Powder for nebuliser suspension Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed

in the specified liquid to obtain a nebuliser suspension.

Oral / rektal süspansiyon tozu 50052000Powder for oral/rectal suspension Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved

in the specified liquid to obtain an oral/rectal solution.

Oral çözelti tozu 10110000

Powder for oral solution Solid preparation consisting of (a) solid active substance(s) which may also include excipients to facilitate

dissolution in the prescribed liquid. Powders for oral solution include freeze-dried powders. The oral solution is

usually prepared just before administration to the patient.

Oral süspansiyon tozu 10111000

Powder for oral suspension Solid preparation consisting of (a) solid active substance(s) which may also include excipients to facilitate

dispersion in the prescribed liquid and to prevent sedimentation during storage of the oral suspension. Powders

for oral suspension include freeze-dried powders. The oral suspension is usually prepared just before

administration to the patient.

Oral toz 10201000

Oral powder Single-dose or multidose preparation consisting of one or more particulate solids of varying degrees of fineness.

Oral powders are intended for oral administration. They are generally administered in or with water or another

suitable liquid, but may also be swallowed directly.

Periodontal toz 10401000Periodontal powder Solid preparation consisting of one or more powders intended for administration within the tooth

socket/periodontal membrane.

Rektal çözelti tozu 11009000Powder for rectal solution Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved

in the specified liquid to obtain a rectal solution.

Rektal süspansiyon tozu 11010000Powder for rectal suspension Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed

in the specified liquid to obtain a rectal suspension.

Sert kapsülde inhalasyon tozu 11110000

Inhalation powder, hard capsuleSolid single-dose preparation intended for inhalation use, consisting of one or more powders of solid active

substance(s) enclosed in a hard capsule. The capsule is loaded into a dry-powder inhaler to generate an aerosol.

Sinüsiçi çözeltilik toz 13025000Powder for endosinusial solution Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved

in the specified liquid to obtain an endosinusial solution.

Şurup için toz 10118000

Powder for syrup Solid preparation consisting of one or more powders, including freeze-dried powders, that may include

excipients to facilitate dissolution in water and to obtain the characteristics of a syrup, intended to be dissolved

in water to obtain a syrup.

Tek dozluk inhalasyon tozu 11111000

Inhalation powder, pre-dispensedSolid preparation intended for inhalation use, consisting of one or more powders of solid active substance(s)

presented in a suitable pharmaceutical form other than a hard capsule, either in the form of a single dose or

divided into multiple single doses. The preparation is loaded into a dry-powder inhaler to generate an aerosol.

Vezikül içi çözeltisi tozu 50050000 Powder for intravesical solution Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved

in the specified liquid to obtain an intravesical solution

Vezikül içi süspansiyon tozu 50051000Powder for intravesical suspension Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dispersed

in the specified liquid to obtain an intravesical suspension.


Kese 30047500Pouch Small bag made of a suitable material containing a single dose of a medicinal product, to be placed in a cavity of

the body for release of the active substance(s)

Pellet Pellet

Mikropellet Mikropellet

1.2.1.9 Basınçlı Ürünler 1.2.1.9 Pressurised preparations

1.2.1.10 Radyonüklit Jeneratörler 1.2.1.10 Radionuclide generators

Radyonuklid jeneratör 12106000Radionuclide generator A system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to

be removed by elution or by any other method and used in a radiopharmaceutical.


Kremler Creams

Ağız mukoza kremi 10314010

Oromucosal cream Semi-solid, usually multidose preparation consisting of an oil-in-water emulsion intended for oromucosal use.

Oromucosal creams are applied to the oral cavity or onto a specific part of the oral cavity, other than the

gingivae, to obtain a local effect.

Burun kremi 10801000

Nasal creamSemi-solid single-dose or multidose preparation consisting of a cream, usually of oil-in-water type, intended for

nasal use to obtain a local effect. Nasal creams are usually presented in tubes fitted with a nasal applicator.

Krem 10502000

Cream Semi-solid single-dose or multidose preparation of homogeneous appearance consisting of a lipophilic phase and

an aqueous phase, one of which is finely dispersed in the other. Active substance(s) are dissolved or dispersed in

the basis, which may be hydrophilic or hydrophobic. Creams are intended for cutaneous use. In certain cases,

transdermal delivery may be obtained.

Kulak kremi 10701000Ear cream Semi-solid single-dose or multidose preparation consisting of a cream intended for application to the external

auditory meatus, if necessary by means of a tampon impregnated with the preparation.

Rektal krem 11001000Rectal cream Semi-solid preparation consisting of a cream usually presented in a single-dose container provided with a

suitable applicator, intended for rectal use to obtain a local effect.

Vajinal krem 10901000Vaginal cream Semi-solid preparation consisting of a cream usually presented in a single-dose container provided with a

suitable applicator, intended for vaginal use to obtain a local effect.

Jeller Gels

Ağız mukoza jeli 10313000

Oromucosal gel Semi-solid single-dose or multidose preparation consisting of a hydrophilic gel intended for oromucosal use. It is

applied to the oral cavity or onto a specific part of the oral cavity, to obtain a local effect. Gingival gel is

excluded.

Burun jeli 10802000

Nasal gelSemi-solid single-dose or multidose preparation consisting of usually a hydrophilic gel, intended for nasal use to

obtain a local effect. Nasal gels are usually presented in tubes fitted with a nasal applicator.

Diş jeli 10402000Dental gel Semi-solid, usually multidose preparation consisting of a hydrophilic gel intended for administration on teeth

and gums by rubbing.

Dişeti jeli 10315000Gingival gel Semi-solid single-dose or multidose preparation consisting of a gel intended for gingival use to obtain a local

effect.

İntestinal jel 12120000 Intestinal gel Semi-solid preparation consisting of a gel intended for intestinal use.

Jel 10503000

Gel Semi-solid single-dose or multidose preparation consisting of a single-phase basis of liquids gelled by a suitable

gelling agent, intended for cutaneous use. Active substance(s) are dissolved or dispersed in the basis, which may

be hydrophilic or hydrophobic.

Jellik jel 13014000Gel for gel

Semi-solid preparation consisting of a gel intended for use in the preparation of a gel for cutaneous use.

Kulak jeli 10702000Ear gel Semi-solid single-dose or multidose preparation consisting of a gel intended for application to the external

auditory meatus, if necessary by means of a tampon impregnated with the preparation.

Oral jel 10108000Oral gel Semi-solid single-dose or multidose preparation intended for oral use, consisting of a gel, usually hydrophilic, to

be swallowed after administration to the oral cavity.

Periodontal jel 10410000Periodontal gel

Semi-solid preparation consisting of a gel intended to be placed in the pouch between the tooth and the gingiva.

Rahim ağız kanalı jeli 11701000Endocervical gel

Semi-solid preparation consisting of a gel intended for endocervical use by means of a suitable applicator.

Rektal Jel 11002000Rectal gel Semi-solid preparation consisting of a gel usually presented in a single-dose container provided with a suitable

applicator, intended for rectal use to obtain a local effect.

Transdermal jel 10546250

Transdermal gel Semi-solid single-dose or multidose preparation consisting of a single-phase basis of liquids gelled by a suitable

gelling agent. Active substance(s) is (are) dissolved or dispersed in the basis, which may be hydrophilic or

hydrophobic. Transdermal gels are intended for transdermal use.

Vajinal jel 10902000Vaginal gel Semi-solid preparation consisting of a gel usually presented in a single-dose container provided with a suitable

applicator, intended for vaginal use to obtain a local effect.

Merhemler Ointments

Ağız mukozası merhemi 10314005Oromucosal ointment Semi-solid multidose preparation consisting of an ointment intended for oromucosal use. It is applied to the oral

cavity or onto a specific part of the oral cavity, to obtain a local effect

Burun merhemi 10803000Nasal ointment Semi-solid single-dose or multidose preparation consisting of an ointment, intended for nasal use to obtain a

local effect. Nasal ointments are usually presented in tubes fitted with a nasal applicator.

Deri spreyi, merhem 50016000Cutaneous spray, ointment Ointment formed at the time of administration from a liquid preparation in a pressurised container with a spray

valve or in a container equipped with a spray pump.

Deri/burun merhemi 50015200 Cutaneous/nasal ointment Semi-solid preparation consisting of an ointment intended for cutaneous or nasal use.

Inhalasyon buharı, merhem 11116000Inhalation vapour, ointment Semi-solid preparation consisting of an ointment intended for generation of vapour to be inhaled to obtain a

local effect. The vapour may be generated by adding the ointment to hot water.

Kulak merhemi 10703000

Ear ointmentSemi-solid single-dose or multidose preparation consisting of an ointment intended for application to the

external auditory meatus, if necessary by means of a tampon impregnated with the preparation.

Merhem 10504000

Ointment Semi-solid single-dose or multidose preparation consisting of a single-phase basis in which solids or liquids may

be dispersed. Active substance(s) are dissolved or dispersed in the basis, which may be hydrophilic, hydrophobic

or water-emulsifying. Ointments are intended for cutaneous use. In certain cases, transdermal delivery may be

obtained.

Rektal merhem 11003000Rectal ointment Semi-solid preparation consisting of an ointment usually presented in a single-dose container provided with a

suitable applicator, intended for rectal use to obtain a local effect.

Transdermal merhem 13102000

Transdermal ointmentSemi-solid single-dose or multidose preparation consisting of a single-phase basis in which solids or liquids may

be dispersed. Active substance(s) are dissolved or dispersed in the basis, which may be hydrophilic, hydrophobic

or water-emulsifying. Transdermal ointments are intended for transdermal use.

Vajinal merhem 10903000Vaginal ointment Semi-solid preparation consisting of an ointment usually presented in a single-dose container provided with a

suitable applicator, intended for vaginal use to obtain a local effect.

Patlar Pastes

Ağız mukoza patı 10314000

Oromucosal pasteSemi-solid single-dose or multidose preparation consisting of a paste of solid particles finely dispersed in a

hydrophilic basis intended for oromucosal use. Oromucosal pastes are applied to the oral cavity or onto a

specific part of the oral cavity, to obtain a local effect. Gingival paste is excluded.

Deri patı 10505000Cutaneous paste Semi-solid single-dose or multidose preparation containing a large proportion of finely divided solids dispersed

in the basis, intended for cutaneous use.

Diş macunu 10409000Toothpaste

Semi-solid, usually multidose preparation consisting of a hydrophilic paste intended to be rubbed onto the teeth.

Diş patı

50017000

Dental paste Semi-solid single-dose or multidose preparation consisting of solid particles finely dispersed in a suitable basis,

intended for administration on or inside the tooth or on and/or around the nerves supplying the teeth.

Toothpaste is excluded.

Dişeti patı 10316000Gingival paste Semi-solid single-dose or multidose preparation consisting of a paste of solid particles finely dispersed in a

hydrophilic basis intended for gingival use to obtain a local effect.

Oral pat 10109000Oral paste Semi-solid single-dose or multidose preparation intended for oral use, consisting of a paste to be swallowed

after administration to the oral cavity.

Köpükler Foams

Deri köpüğü 10507000

Cutaneous foam Liquid, usually multidose preparation, usually presented in a pressurised container equipped with an applicator

suitable for delivery of a foam consisting of large volumes of gas dispersed in a liquid containing active

substance(s). Cutaneous foams are intended for cutaneous use.

Rektal köpük 11004000

Rectal foam Liquid preparation, usually presented in a pressurised container provided with an applicator suitable for delivery

to the rectum of foam containing large volumes of gas dispersed in a liquid containing the active substance.

Rectal foams are intended for a local effect.

Vajinal köpük 10904000

Vaginal foamLiquid preparation, usually presented in a pressurised container provided with an applicator suitable for delivery

to the vagina of foam containing large volumes of gas dispersed in a liquid containing active substance(s).

Vaginal foams are intended for vaginal use, for example for contraception.

Lapalar Poultice

Lapa 10522000

Poultice Semi-solid preparation consisting of a hydrophilic heat-retentive basis in which solid or liquid active substance(s)

are dispersed, usually intended to be spread thickly on a suitable dressing and heated before application to the

skin.


Diş dolgu maddesi 10401500Dental cement Semi-solid preparation intended for application in or on teeth, which subsequently hardens to form a seal or

bond.

1.2.1.12 Süpozituvarlar 1.2.1.12 Suppositories

Ovül 10909000

Pessary Solid, single-dose preparation usually prepared by moulding, of various shapes, usually ovoid, with a volume and

consistency suitable for insertion into the vagina to obtain a local effect. It contains one or more active

substances dispersed or dissolved in a suitable basis that may be soluble or dispersible in water or may melt at

body temperature.

Supozituvar 11013000

Suppository Solid single-dose preparation of a shape, size and consistency suitable for rectal use, containing active

substance(s) dispersed or dissolved in a suitable basis that may be soluble or dispersible in water or may melt at

body temperature.

1.2.1.13 Tabletler 1.2.1.13 Tablets

Ağız çalkalama çözelti tableti 10311000Mouthwash, tablet for solution

Solid preparation consisting of an uncoated tablet intended to be dissolved in water to obtain a mouthwash.

Ağızda dağılan tablet 10223000Orodispersible tablet Solid single-dose preparation consisting of an uncoated tablet intended to be placed in the mouth where it

disperses rapidly in saliva before being swallowed.

Bukkal tablet 10320000

Buccal tablet Solid single-dose preparation to be applied to the buccal cavity (pouch) to obtain systemic delivery. Buccal

tablets are prepared by compression of mixtures of powders or granulations into tablets with a shape suited for

the intended use.

Çiğneme tableti 10228000Chewable tablet Solid single-dose preparation consisting of an uncoated tablet intended to be chewed before being swallowed.

Chewable tablets are intended for oral administration.

Çiğnenebilir / dağılabilir tablet 50001000Chewable/dispersible tablet Solid single-dose preparation consisting of an uncoated tablet intended either to be chewed before being

swallowed, or to be dispersed in the specified liquid before being swallowed.

Çözünebilir tablet 10120000Soluble tablet Solid single-dose preparation consisting of a tablet, usually uncoated, intended to be dissolved in the specified

liquid before being swallowed.

Değiştirilmiş salımlı tablet 10227000

Modified-release tabletSolid single-dose preparation consisting of a tablet showing a rate, a place and/or a time of release different

from that of a conventional-release tablet. This deliberate modification is achieved by a special formulation

design and/or manufacturing method. Modified-release tablets are intended for oral use, and include prolonged-

release, delayed-release and pulsatile-release preparations. The generic term 'modified-release tablet' is used

only when the more specific terms 'gastro-resistant tablet' or 'prolonged-release tablet' do not apply.

Deri çözeltisi için tablet 13066000Tablet for cutaneous solution Solid, usually single-dose preparation consisting of a tablet, usually uncoated, intended to be dissolved in the

specified liquid to obtain a cutaneous solution.

Dilaltı tablet 10318000

Sublingual tablet Solid single-dose preparation consisting of an uncoated tablet intended for sublingual use. Sublingual tablets are

usually prepared by compression of mixtures of powders or granulations into tablets with a shape suited for the

intended use. Other technologies such as moulding may be used.

Doz dağıtımlı dağılabilir tablet 10121500

Dispersible tablets for dose dispenser Solid preparation consisting of small, dispersible tablets that are designed to be used in a dose dispenser, each

tablet usually consisting of a small fraction of a dose, with multiple tablets being automatically counted and

administered as a single dose.

Efervesan tablet 10222000

Effervescent tabletSolid single-dose preparation consisting of an uncoated tablet generally containing acid substances and

carbonates or hydrogen carbonates, which react rapidly in the presence of water to release carbon dioxide.

Effervescent tablets are intended to be dissolved or dispersed in water before oral use.

Efervesan vajinal tablet 10913000

Effervescent vaginal tabletSolid single-dose preparation consisting of a vaginal tablet usually containing acid substances and carbonates or

hydrogen carbonates that react rapidly in the presence of aqueous liquid to release carbon dioxide.

Enterik tablet 10225000

Gastro-resistant tablet Solid single-dose, delayed-release tablet intended to resist the gastric fluid and to release the active substance(s)

in the intestinal fluid. These properties are achieved by coating the tablet with a gastro-resistant material or by

embedding solid particles in the gastro-resistant material before compression. Gastro-resistant tablets are

intended for oral administration.

Film kaplı tablet 10221000

Film-coated tabletSolid single-dose preparation consisting of a tablet coated with a thin polymeric film that dissolves within a few

minutes in the gastrointestinal fluid. Film-coated tablets are intended for oral use to release active substance(s)

at a rate which is not significantly delayed compared to that of the uncoated tablet.

Gargara, çözelti tableti 10304000 Gargle, tablet for solution Solid preparation consisting of a tablet intended to be dissolved in water to obtain a gargle.

Inhalasyon buharı, tablet 11115000Inhalation vapour, tablet Solid preparation consisting of a tablet intended for generation of vapour to be inhaled to obtain a local effect.

The vapour is usually generated by adding the tablet to hot water.

İnhalasyon buharı, efervesan tablet 50031000

Inhalation vapour, effervescent tablet Solid preparation consisting of a tablet usually containing acid substances and carbonates or hydrogen

carbonates that react rapidly in the presence of aqueous liquid to release carbon dioxide, intended for

generation of vapour to be inhaled to obtain a local effect. The vapour may be generated by adding the tablet to

hot water.

İnhalasyon tozu, tablet 50030000

Inhalation powder, tablet Solid multidose preparation intended for inhalation use. The dose of inhalation powder is generated from the

tablet by a metering mechanism within the inhaler, for example by scraping off a small amount of powder from

the tablet.

Kaplanmış Tablet 10220000

Coated tablet Solid single-dose preparation consisting of a tablet coated with one or more layers of mixtures of various

substances such as sugars and waxes. To the coating colouring matter, flavouring substances and active

substance(s) may be added. The thickness of the coating is greater than that of a film-coated tablet. Coated

tablets have a smooth surface. They are intended for oral use. When the coating dissolves or disintegrates the

active substance(s) is (are) released into the gastrointestinal fluid at a rate depending essentially on its intrinsic

properties (conventional release).

Mukozaya yapışan ağız içi tableti 10319000

Muco-adhesive buccal tabletSolid single-dose preparation to be applied to the buccal mucosa to obtain a systemic delivery over an extended

period of time. Mucoadhesive buccal tablets are usually prepared by compression of mixtures of powders or

granulations into tablets with a shape suited for the intended use. They usually contain hydrophilic polymers,

which on wetting with saliva produce a flexible hydrogel that adheres to the buccal mucosa.

Rektal çözelti tableti 11011000Tablet for rectal solution Solid, usually single-dose preparation consisting of a tablet, usually uncoated, intended to be dissolved in the

specified liquid to obtain a rectal solution.

Rektal süspansiyon tableti 11012000Tablet for rectal suspension Solid, usually single-dose preparation consisting of a tablet, usually uncoated, intended to be dispersed in the

specified liquid to obtain a rectal suspension.

Süspansiyonluk tablet 10121000Dispersible tablet Solid single-dose preparation consisting of a tablet intended to be dispersed in the specified liquid before being

swallowed.

Tablet 10219000

Tablet Solid single-dose uncoated preparation obtained by compressing uniform volumes of particulate solids or by

other means such as extrusion or moulding. Tablets include single-layer tablets resulting from a single

compression of particles and multi-layer tablets consisting of concentric or parallel layers obtained by successive

compressions of particles of different composition. Tablets are intended for oral use to release active

substance(s) in the gastrointestinal fluids by a rate depending essentially on the intrinsic properties of active

substance(s) (conventional release).

Uzatılmış salımlı tablet 10226000

Prolonged-release tabletSolid single-dose preparation consisting of a tablet showing a slower release of the active substance(s) than that

of a conventional-release tablet. Prolonged release is achieved by a special formulation design and/or

manufacturing method. Prolonged-release tablets are intended for oral use.

Vajinal çözelti tableti 10908000Tablet for vaginal solution Solid, usually single-dose preparation consisting of a tablet, usually uncoated, intended to be dissolved in the

specified liquid to obtain a vaginal solution.

Vajinal tablet 10912000

Vaginal tablet Solid single-dose preparation consisting of a tablet, usually uncoated or film-coated, intended for administration

to the vagina to obtain a local effect. Vaginal tablets are usually of larger size and a different shape from tablets

intended for oral administration.

1.2.1.14 Transdermal Yamalar 1.2.1.14 Transdermal patches

Ağzı mukozası flasteri 50039000

Oromucosal patchFlexible single-dose preparation intended to be applied to the oral cavity to obtain either a systemic or a local

effect by delivering the active substance(s) over a certain period of time, after which it is then removed.

Deri yaması 10517500Cutaneous patch Flexible single-dose preparation intended to be applied to the unbroken skin to obtain a local effect by

penetration of the active substance(s) into the skin.

Transdermal flaster 10519000

Transdermal patch

Flexible single-dose preparation intended to be applied to the unbroken skin to obtain a systemic delivery over

an extended period of time. Transdermal patches consist of a backing sheet supporting a reservoir or a matrix

containing the active substance(s) and on the top a pressure-sensitive adhesive, which assures the adhesion of

the preparation to the skin. The backing sheet is impermeable to the active substance(s) and normally

impermeable to water. In reservoir systems the active substance may be dissolved or dispersed in a semi-solid

basis or in a solid polymer matrix, which is separated from the skin by a rate-controlling membrane. The

pressure-sensitive adhesive may, in this case, be applied to some or all parts of the membrane, or only around

the border of the membrane and the backing sheet. Matrix systems contain the active substance in a solid or

semi-solid matrix, the properties of which control the diffusion pattern to the skin. The matrix system may also

be a solution or dispersion of the active substance in the pressure-sensitive adhesive. The releasing surface of

the patch is covered by a protective liner to be removed before applying the patch to the skin.

1.2.1.15 Diğer Steril Olmayan Ürünler (Açıklama giriniz.) 1.2.1.15 Other (…clarify)

Ağızdan çözelti için saşede granül 50029170 Granules for oral solution in sachet Medicinal product consisting of granules for oral solution presented in a sachet.

Ağızdan süspansiyon için granül ve çözücü50026500

Granules and solvent for oral suspension Granules and solvent intended for the preparation of an oral suspension by dispersing the granules in the

solvent.

Ağızdan süspansiyon için saşede granül 50029200 Granules for oral suspension in sachet Medicinal product consisting of granules for oral suspension presented in a sachet.

Basınçlı kapta jel 50026400 Gel in pressurised container Medicinal product consisting of a gel presented in a pressurised container.

Burun damlası, çözelti için toz ve çözücü50047650

Nasal drops, powder and solvent for solution Powder (including freeze-dried powder) and solvent intended for the preparation of nasal drops, solution, by


Burun damlası, tek dozluk kapta çözelti 50036200 Nasal drops, solution in single-dose container Medicinal product consisting of a nasal drops solution presented in a single-dose container.

Buruna püskürtücü, tek dozluk kapta çözelti 50037250 Nasal spray, solution in single-dose container Medicinal product consisting of a nasal spray solution presented in a single-dose container.

Deri çözeltisi konsantre ve çözücüsü 50003000 Concentrate and solvent for cutaneous solution Concentrate and solvent intended for the preparation of a cutaneous solution by diluting the concentrate with

the solvent.

Deri çözeltisi tozu ve çözücüsü 50044000Powder and solvent for cutaneous solution Powder (including freeze-dried powder) and solvent intended for the preparation of a cutaneous solution by


Deri çözeltisi, tek dozluk kapta 13103000 Cutaneous solution in single-dose container Medicinal product consisting of a cutaneous solution presented in a single-dose container.

Diş dolgu maddesi için toz ve çözelti10412000

Powder and solution for dental cement Powder (including freeze-dried powder) and solution, both containing active substance(s), intended for the

preparation of a dental cement by mixing the powder and the solution.

Diş eti jeli tozu ve çözücüsü 50046000Powder and solvent for gingival gel Powder (including freeze-dried powder) and solvent intended for the preparation of a gingival gel by mixing the

powder and the solvent.

Diş jeli tozu ve çözücüsü 50071000Powder and solvent for dental gel Powder (including freeze-dried powder) and solvent intended for the preparation of a dental gel by mixing the

powder and the solvent.

Endotrakeopulmoner damlatma tozu ve çözücüsü11604000

Endotracheopulmonary instillation, powder and solvent for solution Powder (including freeze-dried powder) and aqueous solvent intended for the preparation of an

endotracheopulmonary instillation solution by dissolving the powder in the solvent.

Endotrakeopulmoner süspansiyonluk için damlatma, toz ve çözücü11605000

Endotracheopulmonary instillation, powder and solvent for suspension Powder (including freeze-dried powder) and aqueous solvent intended for the preparation of an

endotracheopulmonary instillation suspension by dispersing the powder in the solvent.

Kesede ağız mukozası tozu 50039300 Oromucosal powder in pouch Medicinal product consisting of an oromucosal powder presented in a pouch.

Kulak damlası, süspansiyonluk toz ve çözücüsü 10707000Ear drops, powder and solvent for suspension Powder (including freeze-dried powder) and solvent intended for the preparation of ear drops, suspension, by

dispersing the powder in the solvent.

Kulak damlası, tek dozluk kapta çözelti 50017200 Ear drops, solution in single-dose container Medicinal product consisting of an ear drops solution presented in a single-dose container.

Kulak damlası, tek dozluk kapta süspansiyon 50017550 Ear drops, suspension in single-dose container Medicinal product consisting of an ear drops suspension presented in a single-dose container.

Kullanıma hazır ağızdan uygulayıcıda süspansiyon 13075000 Oral suspension in pre-filled oral applicator Medicinal product consisting of an oral suspension presented in a pre-filled oral applicator.

Mesaneiçi çözeltisi için toz ve çözücü50047500

Powder and solvent for intravesical solution Powder (including freeze-dried powder) and solvent intended for the preparation of an intravesical solution by


Mesaneiçi süspansiyonu için toz ve çözücü50047600

Powder and solvent for intravesical suspension Powder (including freeze-dried powder) and solvent intended for the preparation of an intravesical suspension

by dispersing the powder in the solvent.

Nebülizör çözelti için toz ve çözücü50047700

Powder and solvent for nebuliser solution Powder (including freeze-dried powder) and solvent intended for the preparation of a nebuliser solution by


Oral çözelti tableti ve tozu 50065000Tablet and powder for oral solution Tablet and powder, both containing active substance(s), intended for the preparation of an oral solution by

dissolving the tablet and the powder in the specified liquid.

Oral çözelti tozu ve çözücüsü 10114000Powder and solvent for oral solution Powder (including freeze-dried powder) and solvent intended for the preparation of an oral solution by


Oral süspansiyon tozu ve çözücüsü 10115000Powder and solvent for oral suspension Powder (including freeze-dried powder) and solvent intended for the preparation of an oral suspension by

dispersing the powder in the solvent.

Oral süspansiyonluk efervesan granül ve süspansiyon50062000

Suspension and effervescent granules for oral suspension Suspension and effervescent granules, both containing active ingredients, intended for the preparation of an oral

suspension by dissolving or dispersing the granules in the suspension.

Pilül, tek dozluk kap 50041000 Pillules in single-dose container Medicinal product consisting of pillules presented in a single-dose container.

Püskürtücü için süspansiyon ve çözelti 50062500 Suspension and solution for spray Suspension and solution for spray

Rahim ağız kanalı jeli için toz ve çözücü11702000

Powder and solvent for endocervical gel Powder (including freeze-dried powder) and solvent intended for the preparation of an endocervical gel by

mixing the powder and the solvent.

Rahim içi uygulama sistemi 11901000Intrauterine delivery system Solid single-dose delivery system intended for intrauterine use that releases its contents of active substance(s)

over an extended period of time.

Rektal süspansiyonluk tablet ve çözücüsü 50064000Tablet and solvent for rectal suspension

Tablet and solvent intended for the preparation of a rectal suspension by dispersing the tablet in the solvent.

Saşede ağızdan çözelti 50038600 Oral solution in sachet Medicinal product consisting of an oral solution presented in a sachet.

Saşede ağızdan çözeltilik toz 50052500 Powder for oral solution in sachet Medicinal product consisting of a powder for oral solution presented in a sachet.

Saşede ağızdan emülsiyon 50037600 Oral emulsion in sachet Medicinal product consisting of an oral emulsion presented in a sachet.

Saşede ağızdan pat 50037700 Oral paste in sachet Medicinal product consisting of an oral paste presented in a sachet.

Saşede ağızdan süspansiyon 50038700 Oral suspension in sachet Medicinal product consisting of an oral suspension presented in a sachet.

Saşede ağızdan süspansiyonluk midede dayanıklı granül 50026150 Gastro-resistant granules for oral suspension in sachet Medicinal product consisting of gastro-resistant granules for oral suspension presented in a sachet.

Saşede ağızdan süspansiyonluk uzatılmış salımlı granül 50056150 Prolonged-release granules for oral suspension in sachetMedicinal product consisting of prolonged-release granules for oral suspension presented in a sachet.

Saşede ağızdan toz 50037800 Oral powder in sachet Medicinal product consisting of an oral powder presented in a sachet.

Saşede ağızdan/makattan süspansiyonluk toz 13060000 Powder for oral/rectal suspension in sachet Medicinal product consisting of a powder for oral/rectal suspension presented in a sachet.

Saşede granül 50029550 Granules in sachetMedicinal product consisting of granules presented in a sachet, the entire contents of which are intended for

oral administration as a single dose. For reasons of patient safety and to ensure the correct administration of

the medicinal product, this term may also be used where the contents are in fact very small tablets rather than

granules, and where the entire contents of the sachet are intended for oral administration as a single dose,

rather than the tablets being individually counted out at the time of administration.

Saşede jel 13069000 Gel in sachet Medicinal product consisting of a gel presented in a sachet.

Saşede kaplı granül 50001250 Coated granules in sachet Medicinal product consisting of coated granules presented in a sachet.

Saşede midede dayanıklı granül ve film kaplı tablet 50023700 Film-coated tablet and gastro-resistant granules in sachetMedicinal product consisting of a film-coated tablet and gastro-resistant granules presented together in a sachet

and intended to be swallowed together as a single dose. If two or more tablets are present to make up the dose,

the term ‘Film-coated tablets and gastro-resistant granules in sachet’ is used.

Saşede şurup 13094000 Syrup in sachet Medicinal product consisting of a syrup in a sachet.

Saşede uzatılmış salımlı granül 50056200 Prolonged-release granules in sachet Medicinal product consisting of prolonged-release granules presented in a sachet.

Sinüs içi çözeltisi tozu ve çözücüsü 50045000Powder and solvent for endosinusial solution Powder (including freeze-dried powder) and solvent intended for the preparation of an endosinusial solution by


Şurup için toz ve çözücü 10115500Powder and solvent for syrup Powder (including freeze-dried powder) and solvent intended for the preparation of a syrup by dissolving the

powder in the solvent.

Tek dozluk kapta ağızdan çözelti 50038650 Oral solution in single-dose container Medicinal product consisting of an oral solution presented in a single-dose container.

Tek dozluk kapta granül 13090000 Granules in single-dose container Medicinal product consisting of granules presented in a single-dose container.

Torba çay 50029700 Herbal tea in bag Medicinal product consisting of a herbal tea enclosed in a porous bag (a tea bag) intended to be placed in water

for the preparation of an oral aqueous preparation on one occasion only.

Toz ve jellik jel50041200

Powder and gel for gelPowder and gel intended for the preparation of a gel (for cutaneous use) by mixing the powder in the gel.

Transdermal sistem 10547000Transdermal system Assembly of components intended for transdermal delivery driven by external forces (e.g. electric current,

chemical reaction,...). Transdermal patch is excluded.

Vajinal uygulama sistemi 10915000Vaginal delivery system Drug delivery system intended to be inserted in the vagina where it releases its contents over an extended

period of time. Medicated sponge and medicated vaginal tampon are excluded.

1.2.2 Seri Serbest Bırakma İşlemleri 1.3 Biological medicinal products

1.3 Biyolojik Tıbbi Ürünler 1.3.1 Biological medicinal products

1.3.1 Biyolojik Tıbbi Ürünler 1.3.1.1 Blood products

1.3.1.1 Kan Ürünleri 1.3.1.2 Immunological products

1.3.1.2 İmmünolojik Ürünler 1.3.1.3 Cell therapy products

1.3.1.3 Hücre Tedavisi Ürünleri 1.3.1.4 Gene therapy products

1.3.1.4 Gen Tedavisi Ürünleri 1.3.1.5 Biotechnology products

1.3.1.5 Biyoteknolojik Ürünler 1.3.1.6 Human or animal extract derived products

1.3.1.6 İnsan/Hayvan Ekstraktı Kaynaklı Ürünler

1.3.1.7 Doku Mühendisliği Ürünleri 1.3.1.7 Tissue engineering products

Canlı doku eşdeğeri 12118000

Living tissue equivalent Cultured, living tissue used for the reconstruction of parts of the body. The tissue may consist of ex vivo

expanded cells with an extracellular matrix. Where appropriate, the tissue of origin, such as epidermis, dermis,

cartilage or muscle, will need to be stated elsewhere in the product information.

1.3.1.8 Diğer Biyolojik Tıbbi Ürünler (Açıklama giriniz.) 1.3.1.8 Other biological medicinal products (…clarify)

1.1 steril Ürünler 1.1 sterile products 1.1.1 aseptik ... · hemodiyaliz çözeltisi 11404000...

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