¨'v . b ó ² 'ö#. b f j í 4) - jpma¥ b. / ; 2018 -104-'¨5'v . b ó ²...

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᪥ᮏ⸆ࡢ⾜ᨻ 2018 - 104 - 5 ་⸆ရ⟶⌮ሗ౪ఏ㐩 ་⸆ရ〇㐀㈍ᴗ⪅ࠊࡣつᐃ⸆ရ᭷ຠᛶᏳᛶཬရ㉁➼་⸆ရ㐺ṇࡓࡢᚲせሗ㞟ࡇࠊሗ་⸆㛵ಀ⪅ᥦ౪┠ࡢࡇࠋࡓࡢ་⸆ရ〇㐀㈍ᴗ⪅ ࠊࡣGVP┬௧つᐃᇶᡭ㡰᭩ సᡂࡇࠊࡋ་⸆ရᏳ⟶⌮ሗ ᥦ౪ఏ㐩࠸ࡘ⥲ⓗయไഛດ 1㸬་⒪⏝་⸆ရῧ᭩ ་⸆ရ〇㐀㈍ᴗ⪅་⸆㛵ಀ⪅་⸆ရ ሗᥦ౪ఏ㐩፹యᡭẁᮏⓗࡀࡢ་⸆ရῧ᭩ࡢࡇࠋつᐃᇶ་⸆ရ㐺⏝ ᝈ⪅Ᏻ☜ಖࠊࡋ㐺ṇ⏝ᅗṑ⛉་ᖌཬ⸆ࡧᖌ➼་⸆㛵ಀ⪅ᑐ ᚲせሗᥦ౪┠ⓗ་⸆ရ〇㐀㈍ ᴗ⪅సᡂ⩏ࡀබⓗ ࠊࡓ࠸࠾ῧ᭩ཪჾ⿕ໟグ㍕ࡅ࡞ࡋ࡞ࡤ࠸࡞㡯㸦ῧ ᭩➼グ㍕㡯㸧 グ㍕ࡗࡓ࠶␃ࡢព㡯グ㍕⚗ࡢṆ㡯つᐃ20141125᪥⾜ἲᨵṇῧ᭩ ➼グ㍕㡯࠸ࡘㄽ➼ᚓ ▱ࡓぢᇶグ㍕ࡅ࡞ࡋ࡞ࡤࡇ࠸࡞㈍୪⏝ཬᚲせὀព ࠸ࡘ〇㐀㈍㛤ጞཬኚ᭦ᒆฟࡕ┤ࠊࡋබ⾲つᐃࡇࠋࡓ つᐃ㐓⬺ࡓࡋഇㄗゎᣍࡓ࠸グ㍕ෆᐜἲ⨩ලయⓗῧ᭩グ㍕㡯┠グ㍕㡰ᗎཬグ㍕せ㡿୪ὀពグ㍕せ㡿 ࠸ࡘཌ⏕ປാ┬⾜ᨻ㏻▱ࠊࡓ〇㐀㈍ᚋᏳ☜ಖᴗస⏝ ሗ➼㞟ࠊࡋホ౯㔜せෆᐜ࠸ࡘ ῧ᭩㏲ḟࠊ࠾࡞ࠋῧ᭩⣬㠃ཬ㔞㝈ᗘ࠶ࡀ 〇㐀㈍ᴗ⪅➼࠸࠾ࡘࡃ࠸ ሗ፹యసᡂῧ᭩ཬὀពᵝᘧグ㍕ෆᐜ ࠸ࡘࠊࡣ19935ࡇࠕ་⒪་⸆ရ࠶ࡢ⾜ࡓ࠼Ⓨ㊊ࠕࡓࡋ21ୡ⣖་⸆ရ ࠶ࡢ᪉㛵᠓ㄯ㸦⤊ሗ࿌㸧ཬ1995 7ࠕࡢ་⸆ရ㐺ṇ⏝᥎㐍᪉⟇ウ㸦୰ 㛫ሗ࿌㸧➼ῧ᭩㠃ⓗぢ┤ࡢࡋᚲせ ࡢࡇࠊၥ㢟 㸦ᢠ┦ࡢస⏝㔜⠜స⏝Ⓨ⌧㸧┦ࠊస⏝୰ᚰࡓࡋ་⸆ရᏳᛶ㛵ሗᥦ౪࠶ࡢ࠸ࡘᪧཌ ࠊ┬⏕་⒪㛵ಀ⪅〇⸆ᴗ㛫ウ⾜ࡀ⥭ᛴᑐᛂࡉ࡞ࡀ19931124᪥⸆Ⓨ 99919941121᪥〇⸆༠Ⓨ➨1445ࡢࡇ࡞࠺ᪧཌ⏕┬⸆ရῧ᭩ぢ┤➼ࡋ3 ⌜✲◊ࡢࡘタ⨨ヲ⣽19965᭶⟅⏦ ࡢࡑࠊሗ࿌᭩ᇶ19974᭩ཬࠕࡧὀពグ㍕せ㡿㠃ᨵ 3⾜ࡢࡘᨻ㏻▱㏻㐩 ࠋࡓձ ་⒪⏝་⸆ရῧ᭩グ㍕せ㡿࠸ࡘ 1997425᪥⸆Ⓨ➨606ղ ་⒪⏝་⸆ရῧ᭩グ㍕せ㡿࠸ࡘ 1997425᪥⸆Ᏻ➨59ճ ་⒪⏝་⸆ရὀពグ㍕せ㡿1997425᪥⸆Ⓨ➨607ࡢࡇ㏻▱௨ୗ ་⒪㛵ಀ⪅⌮ࡀࠊࡃࡍ ࠸ࡍῧ᭩ᨵ ⛉Ꮫⓗṇ☜ሗᥦ౪ ࡍࡊࠊ࠾࡞20035᭶⏕≀⏤᮶〇ῧ᭩グ ࠸ࡘ⾜ࡢᨻ㏻▱⏕ࠕ≀⏤᮶〇ရῧ᭩ グ㍕࠸ࡘ2003515

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Page 1: ¨'v . b ó ² 'ö#. b f j í 4) - JPMA¥ b. / ; 2018 -104-'¨5'v . b ó ² 'ö#. _ b f j í 4) . b0 42 * c 2 b0d _ | ~ . b w ö ó ² ö l g 2A'¼ . b4: G ^ Q#Ý b S u _ ²0[ ^ _

2018 - 104 -

5

GVP

1

2014 11 25

1993 5

211995

7

1993 11 24999 1994 11 21 1445

31996 51997 4

3

1997 4 25 606

1997 4 25 59

1997 4 25 607

2003 5

2003 5 15

Page 2: ¨'v . b ó ² 'ö#. b f j í 4) - JPMA¥ b. / ; 2018 -104-'¨5'v . b ó ² 'ö#. _ b f j í 4) . b0 42 * c 2 b0d _ | ~ . b w ö ó ² ö l g 2A'¼ . b4: G ^ Q#Ý b S u _ ²0[ ^ _

2018 - 105 -

05150052003 5 20

0520004 2003 7

2006 3 24 0324006

IT

2017 6 8 0608-(1)

2017 6 80608-(1)

2019 45

20148 6 0806-(3) GVP

i. 6

ii. PMDA HP

iii.

2014 9 10901-(1) PMDA HP

PMDA HPPMDA

PMDA

PMDA

PMDA2014

9 1

1.1 1)

Page 3: ¨'v . b ó ² 'ö#. b f j í 4) - JPMA¥ b. / ; 2018 -104-'¨5'v . b ó ² 'ö#. _ b f j í 4) . b0 42 * c 2 b0d _ | ~ . b w ö ó ² ö l g 2A'¼ . b4: G ^ Q#Ý b S u _ ²0[ ^ _

2018 - 106 -

2

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Page 4: ¨'v . b ó ² 'ö#. b f j í 4) - JPMA¥ b. / ; 2018 -104-'¨5'v . b ó ² 'ö#. _ b f j í 4) . b0 42 * c 2 b0d _ | ~ . b w ö ó ² ö l g 2A'¼ . b4: G ^ Q#Ý b S u _ ²0[ ^ _

2018 - 107 -

(14)

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Page 5: ¨'v . b ó ² 'ö#. b f j í 4) - JPMA¥ b. / ; 2018 -104-'¨5'v . b ó ² 'ö#. _ b f j í 4) . b0 42 * c 2 b0d _ | ~ . b w ö ó ² ö l g 2A'¼ . b4: G ^ Q#Ý b S u _ ²0[ ^ _

2018 - 108 -

1988 101988 10 1 853

2002 3 13 170

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2012 3 310331001 0331001

2014 7 100710-(7) 0710-(5)

2005 9 220922001

Page 6: ¨'v . b ó ² 'ö#. b f j í 4) - JPMA¥ b. / ; 2018 -104-'¨5'v . b ó ² 'ö#. _ b f j í 4) . b0 42 * c 2 b0d _ | ~ . b w ö ó ² ö l g 2A'¼ . b4: G ^ Q#Ý b S u _ ²0[ ^ _

2018 - 109 -

20132 14 0214-(1)

2013 8

2005 4

2 20099 5,400

1.7 HP

http://www.e-search.ne.jp/~jpr/

2

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2015 9

662014

2015

2016

2017

2016

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(RMP)

RMP2017 6 5

4 . 1. GVP

2.2 IFIF

MR MR

MR

2013 42013 10

IF

Page 7: ¨'v . b ó ² 'ö#. b f j í 4) - JPMA¥ b. / ; 2018 -104-'¨5'v . b ó ² 'ö#. _ b f j í 4) . b0 42 * c 2 b0d _ | ~ . b w ö ó ² ö l g 2A'¼ . b4: G ^ Q#Ý b S u _ ²0[ ^ _

2018 - 110 -

IFIF PDF

PMDA HP

3

PMDA

2014 11 25

PMDA HP

http://www.pmda.go.jp/files/000144200.pdfPMDA 1 2

PMDAPMDA

5

20 21PMDA

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GVP

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Page 8: ¨'v . b ó ² 'ö#. b f j í 4) - JPMA¥ b. / ; 2018 -104-'¨5'v . b ó ² 'ö#. _ b f j í 4) . b0 42 * c 2 b0d _ | ~ . b w ö ó ² ö l g 2A'¼ . b4: G ^ Q#Ý b S u _ ²0[ ^ _

2018 - 111 -

PMDA

2014 10 31 1031-(1)

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HPPMDA

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2014 10 311031-(1)

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Page 9: ¨'v . b ó ² 'ö#. b f j í 4) - JPMA¥ b. / ; 2018 -104-'¨5'v . b ó ² 'ö#. _ b f j í 4) . b0 42 * c 2 b0d _ | ~ . b w ö ó ² ö l g 2A'¼ . b4: G ^ Q#Ý b S u _ ²0[ ^ _

2018 - 112 -

MR

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PMDA

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Safety Information

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WHO

1973 62001 6 167

Page 10: ¨'v . b ó ² 'ö#. b f j í 4) - JPMA¥ b. / ; 2018 -104-'¨5'v . b ó ² 'ö#. _ b f j í 4) . b0 42 * c 2 b0d _ | ~ . b w ö ó ² ö l g 2A'¼ . b4: G ^ Q#Ý b S u _ ²0[ ^ _

2018 - 113 -

10 PMDA HP

http://www.pmda.go.jp/safety/info-services/drugs/calling-attention/safety-info/0043.html

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2004 4 No. 128

10 1 19 6

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OTC DSU OTC2015 11

PMDA HPhttp://www.pmda.go.jp/safety/info-services/dru

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3.7

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1997 4

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200110

4 . 1. GVP

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http://www.pmda.go.jp/safety/info-services/drugs/0001.html

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PMDA

SGML (Standard Generalized Markup Language)

PDF (Portable Document Format)

PMDA HP2019 4

SGML XML Extensible Markup Language

Page 11: ¨'v . b ó ² 'ö#. b f j í 4) - JPMA¥ b. / ; 2018 -104-'¨5'v . b ó ² 'ö#. _ b f j í 4) . b0 42 * c 2 b0d _ | ~ . b w ö ó ² ö l g 2A'¼ . b4: G ^ Q#Ý b S u _ ²0[ ^ _

2018 - 114 -

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2009 5PMDA HP

PMDA

http://www.pmda.go.jp/safety/info-services/medi-navi/0006.html

5

1996 81998 9

1999 8 12

2011 1014

1999 8 12

2011 10 141014-(7) 1014-(8)

2013 3 27 0327-(1)0327-(1)

1991 3 27165 1991 6 3

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Page 12: ¨'v . b ó ² 'ö#. b f j í 4) - JPMA¥ b. / ; 2018 -104-'¨5'v . b ó ² 'ö#. _ b f j í 4) . b0 42 * c 2 b0d _ | ~ . b w ö ó ² ö l g 2A'¼ . b4: G ^ Q#Ý b S u _ ²0[ ^ _

2018 - 115 -

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Page 13: ¨'v . b ó ² 'ö#. b f j í 4) - JPMA¥ b. / ; 2018 -104-'¨5'v . b ó ² 'ö#. _ b f j í 4) . b0 42 * c 2 b0d _ | ~ . b w ö ó ² ö l g 2A'¼ . b4: G ^ Q#Ý b S u _ ²0[ ^ _

2018 - 116 -

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Page 14: ¨'v . b ó ² 'ö#. b f j í 4) - JPMA¥ b. / ; 2018 -104-'¨5'v . b ó ² 'ö#. _ b f j í 4) . b0 42 * c 2 b0d _ | ~ . b w ö ó ² ö l g 2A'¼ . b4: G ^ Q#Ý b S u _ ²0[ ^ _

2018 - 117 -

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Page 15: ¨'v . b ó ² 'ö#. b f j í 4) - JPMA¥ b. / ; 2018 -104-'¨5'v . b ó ² 'ö#. _ b f j í 4) . b0 42 * c 2 b0d _ | ~ . b w ö ó ² ö l g 2A'¼ . b4: G ^ Q#Ý b S u _ ²0[ ^ _

2018 - 118 -

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Page 16: ¨'v . b ó ² 'ö#. b f j í 4) - JPMA¥ b. / ; 2018 -104-'¨5'v . b ó ² 'ö#. _ b f j í 4) . b0 42 * c 2 b0d _ | ~ . b w ö ó ² ö l g 2A'¼ . b4: G ^ Q#Ý b S u _ ²0[ ^ _

2018 - 119 -

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