2016 ᖺ 3 ᭶ᨵゞ㸦➨ 3 ∧㸧
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᪥ᮏ⑓㝔⸆๣ᖌ఍ࡢ IF グ㍕せ㡿 2013 ࡟‽ᣐࡋ࡚సᡂ
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〇 ๣ ࡢ つ ไ ༊ ศ
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1 㘄୰࢔ࣥࣈࣟ࢟ࢯ࣮ࣝሷ㓟ሷ 15mg
ྡ
࿴ྡ㸸࢔ࣥࣈࣟ࢟ࢯ࣮ࣝሷ㓟ሷ
ὒྡ㸸Ambroxol Hydrochloride
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ᮏ IF ࡣ 2016 ᖺ 3 ᭶ᨵゞ㸦➨ 9 ∧㸧ࡢῧ௜ᩥ᭩ࡢグ㍕࡟ᇶ࡙ࡁసᡂࡋࡓࠋ
᭱᪂ࡢῧ௜ᩥ᭩᝟ሗࡣࠊ་⸆ရ་⒪ᶵჾ᝟ሗᥦ౪࣮࣒࣮࣍࣌ࢪhttp://www.pmda.go.jp/࡟࡚ࡈ☜ㄆࡃࡔࡉ࠸ࠋ
IF฼⏝ࡢᡭᘬࡁࡢᴫせ
㸫᪥ᮏ⑓㝔⸆๣ᖌ఍㸫
1㸬་⸆ရ࢖ࣥࢱࣅ࣮ࣗࣇ࢛࣮࣒సᡂࡢ⤒⦋
་⒪⏝་⸆ရࡢᇶᮏⓗ࡞せ⣙᝟ሗ࡜ࡋ࡚་⒪⏝་⸆ရῧ௜ᩥ᭩㸦௨ୗࠊῧ௜ᩥ᭩࡜␎ࡍ㸧ࡀ࠶ࡿࠋ་⒪
⌧ሙ࡛་ᖌ࣭⸆๣ᖌ➼ࡢ་⒪ᚑ஦⪅ࡀ᪥ᖖᴗົ࡟ᚲせ࡞་⸆ရࡢ㐺ᛶ౑⏝᝟ሗࢆά⏝ࡍࡿ㝿࡟ࡣࠊῧ௜ᩥ
᭩࡟グ㍕ࡉࢀࡓ᝟ሗࢆ⿬௜ࡅࡿ᭦࡟ヲ⣽࡞᝟ሗࡀᚲせ࡞ሙྜࡀ࠶ࡿࠋ
་⒪⌧ሙ࡛ࡣࠊᙜヱ་⸆ရ࡟ࡘ࠸࡚〇⸆௻ᴗࡢ་⸆ရ᝟ሗᢸᙜ⪅➼࡟᝟ሗࡢ㏣ຍㄳồࡸ㉁␲ࢆࡋ࡚᝟ሗ
ࢆ⿵᏶ࡋ࡚ᑐฎࡋ࡚ࡁ࡚࠸ࡿࠋࡇࡢ㝿࡟ᚲせ࡞᝟ሗࢆ⥙⨶ⓗ࡟ධᡭࡍࡿࡓࡵࡢ᝟ሗࣜࢫࢺ࡜ࡋ࡚࢖ࣥࢱࣅ
࣮ࣗࣇ࢛࣮࣒ࡀㄌ⏕ࡋࡓࠋ
᫛࿴63ᖺ࡟᪥ᮏ⑓㝔⸆๣ᖌ఍㸦௨ୗࠊ᪥⑓⸆࡜␎ࡍ㸧Ꮫ⾡➨2ᑠጤဨ఍ࡀࠕ་⸆ရ࢖ࣥࢱࣅ࣮ࣗࣇ࢛࣮
࣒ࠖ
㸦௨ୗࠊIF࡜␎ࡍ㸧ࡢ఩⨨௜ࡅ୪ࡧ࡟ IFグ㍕ᵝᘧࢆ⟇ᐃࡋࡓࠋࡑࡢᚋࠊ་⒪ᚑ஦⪅ྥࡅ୪ࡧ࡟ᝈ⪅ྥ
ࡅ་⸆ရ᝟ሗࢽ࣮ࢬࡢኚ໬ࢆཷࡅ࡚ࠊᖹᡂ10ᖺ9᭶࡟᪥⑓⸆Ꮫ⾡➨3ᑠጤဨ఍࡟࠾࠸࡚ IFグ㍕せ㡿ࡢᨵゞ
ࡀ⾜ࢃࢀࡓࠋ
᭦࡟10ᖺࡀ⤒㐣ࡋࡓ⌧ᅾࠊ་⸆ရ᝟ሗࡢ๰ࡾᡭ࡛࠶ࡿ〇⸆௻ᴗࠊ౑࠸ᡭ࡛࠶ࡿ་⒪⌧ሙࡢ⸆๣ᖌࠊ཮᪉
࡟࡜ࡗ࡚⸆஦࣭་⒪⎔ቃࡣ኱ࡁࡃኚ໬ࡋࡓࡇ࡜ࢆཷࡅ࡚ࠊᖹᡂ20ᖺ9᭶࡟᪥⑓⸆་⸆᝟ሗጤဨ఍࡟࠾࠸࡚
᪂ࡓ࡞IFグ㍕せ㡿ࡀ⟇ᐃࡉࢀࡓࠋ
IFグ㍕せ㡿2008࡛ࡣࠊIFࢆ⣬፹యࡢ෉Ꮚ࡜ࡋ࡚ᥦ౪ࡍࡿ᪉ᘧ࠿ࡽࠊPDF➼ࡢ㟁☢ⓗࢹ࣮ࢱ࡜ࡋ࡚ᥦ౪
ࡍࡿࡇ࡜㸦e-IF㸧ࡀཎ๎࡜࡞ࡗࡓࠋࡇࡢኚ᭦࡟࠶ࢃࡏ࡚ࠊῧ௜ᩥ᭩࡟࠾࠸࡚ࠕຠ⬟࣭ຠᯝࡢ㏣ຍࠖࠊ
ࠕ㆙࿌࣭
⚗ᚷ࣭㔜せ࡞ᇶᮏⓗὀពࡢᨵゞࠖ࡞࡝ࡢᨵゞࡀ࠶ࡗࡓሙྜ࡟ࠊᨵゞࡢ᰿ᣐࢹ࣮ࢱࢆ㏣ຍࡋࡓ᭱᪂∧ࡢe-IF
ࡀᥦ౪ࡉࢀࡿࡇ࡜࡜࡞ࡗࡓࠋ
᭱ ᪂ ∧ ࡢ e-IF ࡣ ࠊ㸦 ⊂ 㸧 ་ ⸆ ရ ་ ⒪ ᶵ ჾ ⥲ ྜ ᶵ ᵓ ࡢ ་ ⸆ ရ ᝟ ሗ ᥦ ౪ ࣍ ࣮ ࣒ ࣌ ࣮ ࢪ
㸦http://www.info.pmda.go.jp/㸧࠿ࡽ୍ᣓࡋ࡚ධᡭྍ⬟࡜࡞ࡗ࡚࠸ࡿࠋ᪥ᮏ⑓㝔⸆๣ᖌ఍࡛ࡣࠊe-IFࢆᥖ㍕
ࡍࡿ་⸆ရ᝟ሗᥦ౪࣮࣒࣮࣍࣌ࢪࡀබᘧࢧ࢖ࢺ࡛࠶ࡿࡇ࡜࡟㓄៖ࡋ࡚ࠊ⸆౯ᇶ‽཰㍕࡟࠶ࢃࡏ࡚e-IFࡢ᝟
ሗࢆ᳨ウࡍࡿ⤌⧊ࢆタ⨨ࡋ࡚ࠊಶࠎࡢIFࡀῧ௜ᩥ᭩ࢆ⿵᏶ࡍࡿ㐺ṇ౑⏝᝟ሗ࡜ࡋ࡚㐺ษ࠿ᑂᰝ᳨࣭ウࡍࡿ
ࡇ࡜࡜ࡋࡓࠋ
2008ᖺࡼࡾᖺ4ᅇࡢ࢖ࣥࢱࣅ࣮ࣗࣇ᳨࢛࣮࣒ウ఍ࢆ㛤ദࡋࡓ୰࡛ᣦ᦬ࡋ࡚ࡁࡓ஦㡯ࢆ෌ホ౯ࡋࠊ〇⸆௻
ᴗ࡟࡜ࡗ࡚ࡶࠊ་ᖌ࣭⸆๣ᖌ➼࡟࡜ࡗ࡚ࡶࠊຠ⋡ࡢⰋ࠸᝟ሗ※࡜ࡍࡿࡇ࡜ࢆ⪃࠼ࡓࠋࡑࡇ࡛௒⯡ࠊIFグ㍕
せ㡿ࡢ୍㒊ᨵゞࢆ⾜࠸IFグ㍕せ㡿2013࡜ࡋ࡚බ⾲ࡍࡿ㐠ࡧ࡜࡞ࡗࡓࠋ
2㸬IF࡜ࡣ
IFࡣࠕῧ௜ᩥ᭩➼ࡢ᝟ሗࢆ⿵᏶ࡋࠊ⸆๣ᖌ➼ࡢ་⒪ᚑ஦⪅࡟࡜ࡗ࡚᪥ᖖᴗົ࡟ᚲせ࡞ࠊ་⸆ရࡢရ㉁⟶
⌮ࡢࡓࡵࡢ᝟ሗࠊฎ᪉タィࡢࡓࡵࡢ᝟ሗࠊㄪ๣ࡢࡓࡵࡢ᝟ሗࠊ་⸆ရࡢ㐺ᛶ౑⏝ࡢࡓࡵࡢ᝟ሗࠊ⸆Ꮫⓗ࡞
ᝈ⪅ࢣ࢔ࡢࡓࡵࡢ᝟ሗ➼ࡀ㞟⣙ࡉࢀࡓ⥲ྜⓗ࡞ಶูࡢ་⸆ရゎㄝ᭩࡜ࡋ࡚ࠊ᪥⑓⸆ࡀグ㍕せ㡿ࢆ⟇ᐃࡋࠊ
⸆๣ᖌ➼ࡢࡓࡵ࡟ᙜヱ་⸆ရࡢ〇⸆௻ᴗ࡟సᡂཬࡧᥦ౪ࢆ౫㢗ࡋ࡚࠸ࡿᏛ⾡㈨ᩱࠖ࡜఩⨨௜ࡅࡽࢀࡿࠋ
ࡓࡔࡋࠊ⸆஦ἲ࣭〇⸆௻ᴗᶵᐦ➼࡟㛵ࢃࡿࡶࡢࠊ〇⸆௻ᴗࡢ〇๣ດຊࢆ↓ຠ࡟ࡍࡿࡶࡢཬࡧ⸆๣ᖌ⮬ࡽ
ࡀホ౯ุ࣭᩿࣭ᥦ౪ࡍ࡭ࡁ஦㡯➼ࡣIFࡢグ㍕஦㡯࡜ࡣ࡞ࡽ࡞࠸ࠋゝ࠸᥮࠼ࡿ࡜ࠊ〇⸆௻ᴗ࠿ࡽᥦ౪ࡉࢀࡓ
IFࡣࠊ⸆๣ᖌ⮬ࡽࡀホ౯ุ࣭᩿࣭⮫ᗋ㐺ᛂࡍࡿ࡜࡜ࡶ࡟ࠊᚲせ࡞⿵᏶ࢆࡍࡿࡶࡢ࡜࠸࠺ㄆ㆑ࢆᣢࡘࡇ࡜ࢆ
๓ᥦ࡜ࡋ࡚࠸ࡿࠋ
㹙IFࡢᵝᘧ㹛
ձつ᱁ࡣA4∧ࠊᶓ᭩ࡁ࡜ࡋࠊཎ๎࡜ࡋ࡚9࣏࢖ࣥࢺ௨ୖࡢᏐయ㸦ᅗ⾲ࡣ㝖ࡃ㸧࡛グ㍕ࡋࠊ୍Ⰽๅࡾ࡜ࡍࡿࠋ
ࡓࡔࡋࠊῧ௜ᩥ᭩࡛㉥ᯟ࣭㉥Ꮠࢆ⏝࠸ࡓሙྜ࡟ࡣࠊ㟁Ꮚ፹య࡛ࡣࡇࢀ࡟ᚑ࠺ࡢࡶ࡜ࡍࡿࠋ
ղIFグ㍕せ㡿࡟ᇶ࡙ࡁసᡂࡋࠊྛ㡯┠ྡࡣࢦࢩࢵࢡయ࡛グ㍕ࡍࡿࠋ
ճ⾲⣬ࡢグ㍕ࡣ⤫୍ࡋࠊ⾲⣬࡟⥆ࡅ࡚᪥⑓⸆సᡂࡢࠕIF฼⏝ࡢᡭᘬࡁࡢᴫせࠖࡢ඲ᩥࢆグ㍕ࡍࡿࡶࡢ࡜ࡋࠊ
2㡫࡟ࡲ࡜ࡵࡿࠋ
㹙IFࡢసᡂ㹛
ձIFࡣཎ๎࡜ࡋ࡚〇๣ࡢᢞ୚⤒㊰ู㸦ෆ⏝๣ࠊὀᑕ๣ࠊእ⏝๣㸧࡟సᡂࡉࢀࡿࠋ
ղIF࡟グ㍕ࡍࡿ㡯┠ཬࡧ㓄ิࡣ᪥⑓⸆ࡀ⟇ᐃࡋࡓIFグ㍕せ㡿࡟‽ᣐࡍࡿࠋ
ճῧ௜ᩥ᭩ࡢෆᐜࢆ⿵᏶ࡍࡿ࡜ࡢIFࡢ୺᪨࡟ἢࡗ࡚ᚲせ࡞᝟ሗࡀグ㍕ࡉࢀࡿࠋ
մ〇⸆௻ᴗࡢᶵᐦ➼࡟㛵ࡍࡿࡶࡢࠊ〇⸆௻ᴗࡢ〇๣ດຊࢆ↓ຠ࡟ࡍࡿࡶࡢཬࡧ⸆๣ᖌࢆࡣࡌࡵ་⒪ᚑ஦⪅
⮬ࡽࡀホ౯ุ࣭᩿࣭ᥦ౪ࡍ࡭ࡁ஦㡯࡟ࡘ࠸࡚ࡣグ㍕ࡉࢀ࡞࠸ࠋ
յࠕ་⸆ရ࢖ࣥࢱࣅ࣮ࣗࣇ࢛࣮࣒グ㍕せ㡿2013ࠖ㸦௨ୗࠊࠕIFグ㍕せ㡿2013ࠖ࡜␎ࡍ㸧࡟ࡼࡾసᡂࡉࢀࡓIF
ࡣࠊ㟁Ꮚ፹య࡛ࡢᥦ౪ࢆᇶᮏ࡜ࡋࠊᚲせ࡟ᛂࡌ࡚⸆๣ᖌࡀ㟁Ꮚ፹య㸦PDF㸧࠿ࡽ༳ๅࡋ࡚౑⏝ࡍࡿࠋ௻
ᴗ࡛ࡢ〇ᮏࡣᚲ㡲࡛ࡣ࡞࠸ࠋ
㹙IFࡢⓎ⾜㹛
ձࠕIFグ㍕せ㡿2013ࠖࡣࠊᖹᡂ25ᖺ10᭶௨㝆࡟ᢎㄆࡉࢀࡓ᪂་⸆ရ࠿ࡽ㐺⏝࡜࡞ࡿࠋ
ղୖグ௨እࡢ་⸆ရ࡟ࡘ࠸࡚ࡣࠊ
ࠕIFグ㍕せ㡿2013ࠖ࡟ࡼࡿసᡂ࣭ᥦ౪ࡣᙉไࡉࢀࡿࡶࡢ࡛ࡣ࡞࠸ࠋ
ճ౑⏝ୖࡢὀពࡢᨵゞࠊ෌ᑂᰝ⤖ᯝཪࡣ෌ホ౯⤖ᯝ㸦⮫ᗋ෌ホ౯㸧ࡀබ⾲ࡉࢀࡓ᫬Ⅼ୪ࡧ࡟㐺ᛂ⑕ࡢᣑ኱
➼ࡀ࡞ࡉࢀࠊグ㍕ࡍ࡭ࡁෆᐜࡀ኱ࡁࡃኚࢃࡗࡓሙྜ࡟ࡣIFࡀᨵゞࡉࢀࡿࠋ
3㸬IFࡢ฼⏝࡟࠶ࡓࡗ࡚
ࠕIFグ㍕せ㡿2013ࠖ࡟࠾࠸࡚ࡣࠊPDFࣇ࢓࢖ࣝ࡟ࡼࡿ㟁Ꮚ፹య࡛ࡢᥦ౪ࢆᇶᮏ࡜ࡋ࡚࠸ࡿࠋ᝟ሗࢆ฼⏝
ࡍࡿ⸆๣ᖌࡣࠊ㟁Ꮚ፹య࠿ࡽ༳ๅࡋ࡚฼⏝ࡍࡿࡇ࡜ࡀཎ๎࡛࠶ࡿࠋ
㟁Ꮚ፹యࡢIF࡟ࡘ࠸࡚ࡣࠊ་⸆ရ་⒪ᶵჾ⥲ྜᶵᵓࡢ་⸆ရ་⒪ᶵჾ᝟ሗᥦ౪࣮࣒࣮࣍࣌ࢪ࡟ᥖ㍕ሙᡤ
ࡀタᐃࡉࢀ࡚࠸ࡿࠋ
〇⸆௻ᴗࡣࠕ་⸆ရ࢖ࣥࢱࣅ࣮ࣗࣇ࢛࣮࣒సᡂࡢᡭᘬࡁࠖ࡟ᚑࡗ࡚సᡂ࣭ᥦ౪ࡍࡿࡀࠊIFࡢཎⅬࢆ㋃ࡲ
࠼ࠊ་⒪⌧ሙ࡟୙㊊ࡋ࡚࠸ࡿ᝟ሗࡸIFసᡂ᫬࡟グ㍕ࡋ㞴࠸᝟ሗ➼࡟ࡘ࠸࡚ࡣ〇⸆௻ᴗࡢMR➼࡬ࡢ࢖ࣥࢱࣅ
࣮ࣗ࡟ࡼࡾ⸆๣ᖌ➼⮬ࡽࡀෆᐜࢆ඘ᐇࡉࡏࠊIFࡢ฼⏝ᛶࢆ㧗ࡵࡿᚲせࡀ࠶ࡿࠋࡲࡓࠊ㝶᫬ᨵゞࡉࢀࡿ౑⏝
ୖࡢὀព➼࡟㛵ࡍࡿ஦㡯࡟㛵ࡋ࡚ࡣࠊIFࡀᨵゞࡉࢀࡿࡲ࡛ࡢ㛫ࡣࠊᙜヱ་⸆ရࡢ〇⸆௻ᴗࡀᥦ౪ࡍࡿῧ௜
ᩥ᭩ࡸ࠾▱ࡽࡏᩥ᭩➼ࠊ࠶ࡿ࠸ࡣ་⸆ရ་⒪ᶵჾ᝟ሗ㓄ಙࢧ࣮ࣅࢫ➼࡟ࡼࡾ⸆๣ᖌ➼⮬ࡽࡀᩚഛࡍࡿ࡜࡜
ࡶ࡟ࠊIFࡢ౑⏝࡟࠶ࡓࡗ࡚ࡣࠊ᭱᪂ࡢῧ௜ᩥ᭩ࢆ་⸆ရ་⒪ᶵჾ᝟ሗᥦ౪࣮࣒࣮࣍࣌ࢪ࡛☜ㄆࡍࡿࠋ
࡞࠾ࠊ㐺ṇ౑⏝ࡸᏳ඲ᛶࡢ☜ಖࡢⅬ࠿ࡽグ㍕ࡉࢀ࡚࠸ࡿࠕ⮫ᗋᡂ⦼ࠖࡸࠕ୺࡞እᅜ࡛ࡢⓎ኎≧ἣࠖ࡟㛵
ࡍࡿ㡯┠➼ࡣᢎㄆ஦㡯࡟㛵ࢃࡿࡇ࡜ࡀ࠶ࡾࠊࡑࡢྲྀᢅ࠸࡟ࡣ༑ศ␃ពࡍ࡭ࡁ࡛࠶ࡿࠋ
4㸬฼⏝࡟㝿ࡋ࡚ࡢ␃ពⅬ
IFࢆ⸆๣ᖌ➼ࡢ᪥ᖖᴗົ࡟࠾࠸࡚Ḟ࠿ࡍࡇ࡜ࡀ࡛ࡁ࡞࠸་⸆ရ᝟ሗ※࡜ࡋ࡚ά⏝ࡋ࡚㡬ࡁࡓ࠸ࠋࡋ࠿ࡋࠊ
⸆஦ἲࡸ་⒪⏝་⸆ရࣉ࣮ࣟࣔࢩࣙࣥࢥ࣮ࢻ➼࡟ࡼࡿつไ࡟ࡼࡾࠊ〇⸆௻ᴗࡀ་⸆ရ᝟ሗ࡜ࡋ࡚ᥦ౪࡛ࡁ
ࡿ⠊ᅖ࡟ࡣ⮬ࡎ࡜㝈⏺ࡀ࠶ࡿࠋIFࡣ᪥⑓⸆ࡢグ㍕せ㡿ࢆཷࡅ࡚ࠊᙜヱ་⸆ရࡢ〇⸆௻ᴗࡀసᡂ࣭ᥦ౪ࡍࡿ
ࡶࡢ࡛࠶ࡿࡇ࡜࠿ࡽࠊグ㍕࣭⾲⌧࡟ࡣไ⣙ࢆཷࡅࡊࡿࢆᚓ࡞࠸ࡇ࡜ࢆㄆ㆑ࡋ࡚࠾࠿࡞ࡅࢀࡤ࡞ࡽ࡞࠸ࠋ
ࡲࡓ〇⸆௻ᴗࡣࠊIFࡀ࠶ࡃࡲ࡛ࡶῧ௜ᩥ᭩ࢆ⿵᏶ࡍࡿ᝟ሗ㈨ᮦ࡛࠶ࡾࠊ௒ᚋ࢖ࣥࢱ࣮ࢿࢵࢺ࡛ࡢබ㛤➼
ࡶ㋃ࡲ࠼ࠊ⸆஦ἲୖࡢᗈ࿌つไ࡟᢬ゐࡋ࡞࠸ࡼ࠺␃ពࡋసᡂࡉࢀ࡚࠸ࡿࡇ࡜ࢆ⌮ゎࡋ࡚᝟ሗࢆά⏝ࡍࡿᚲ
せࡀ࠶ࡿࠋ
㸦2013 ᖺ 4 ᭶ᨵゞ㸧
┠ ḟ
㹇㸬ᴫせ࡟㛵ࡍࡿ㡯┠
㸯㸬㛤Ⓨࡢ⤒⦋ ------------------------------------------------------------------------------------------------------------------ 1
㸰㸬〇ရࡢ἞⒪Ꮫⓗ࣭〇๣Ꮫⓗ≉ᛶ --------------------------------------------------------------------------------------- 1
㹇㹇㸬ྡ⛠࡟㛵ࡍࡿ㡯┠
㸯.㈍኎ྡ
㸦㸯㸧࿴ྡ ------------------------------------------------------------------------------------------------------------------------ 2
㸦㸰㸧ὒྡ ------------------------------------------------------------------------------------------------------------------------ 2
㸦㸱㸧ྡ⛠ࡢ⏤᮶ --------------------------------------------------------------------------------------------------------------- 2
㸰㸬୍⯡ྡ
㸦㸯㸧࿴ྡ㸦࿨ྡἲ㸧 --------------------------------------------------------------------------------------------------------- 2
㸦㸰㸧ὒྡ㸦࿨ྡἲ㸧 --------------------------------------------------------------------------------------------------------- 2
㸦㸱㸧ࢫࢸ࣒ --------------------------------------------------------------------------------------------------------------------- 2
㸱㸬ᵓ㐀ᘧཪࡣ♧ᛶᘧ --------------------------------------------------------------------------------------------------------- 2
㸲㸬ศᏊᘧཬࡧศᏊ㔞 --------------------------------------------------------------------------------------------------------- 2
㸳㸬໬Ꮫྡ㸦࿨ྡἲ㸧 --------------------------------------------------------------------------------------------------------- 2
㸴㸬័⏝ྡࠊูྡࠊ␎ྕࠊグྕ␒ྕ --------------------------------------------------------------------------------------- 2
㸵㸬CAS Ⓩ㘓␒ྕ -------------------------------------------------------------------------------------------------------------- 2
㹇㹇㹇㸬᭷ຠᡂศ࡟㛵ࡍࡿ㡯┠
㸯㸬≀⌮໬Ꮫⓗᛶ㉁
㸦㸯㸧እほ࣭ᛶ≧ --------------------------------------------------------------------------------------------------------------- 3
㸦㸰㸧⁐ゎᛶ --------------------------------------------------------------------------------------------------------------------- 3
㸦㸱㸧྾‵ᛶ --------------------------------------------------------------------------------------------------------------------- 3
㸦㸲㸧⼥Ⅼ㸦ศゎⅬ㸧
ࠊἛⅬࠊจᅛⅬ ------------------------------------------------------------------------------------- 3
㸦㸳㸧㓟ሷᇶゎ㞳ᐃᩘ --------------------------------------------------------------------------------------------------------- 3
㸦㸴㸧ศ㓄ಀᩘ ------------------------------------------------------------------------------------------------------------------ 3
㸦㸵㸧ࡑࡢ௚ࡢ୺࡞♧ᛶ್ --------------------------------------------------------------------------------------------------- 3
㸰㸬᭷ຠᡂศࡢྛ✀᮲௳ୗ࡟࠾ࡅࡿᏳᐃᛶ ------------------------------------------------------------------------------ 3
㸱㸬᭷ຠᡂศࡢ☜ㄆヨ㦂ἲ --------------------------------------------------------------------------------------------------- 3
㸲㸬᭷ຠᡂศࡢᐃ㔞ἲ --------------------------------------------------------------------------------------------------------- 3
㹇㹔㸬〇๣࡟㛵ࡍࡿ㡯┠
㸯㸬๣ᙧ
㸦㸯㸧๣ᙧࡢ༊ูࠊእほཬࡧᛶ≧ ------------------------------------------------------------------------------------------ 4
㸦㸰㸧〇๣ࡢ≀ᛶ --------------------------------------------------------------------------------------------------------------- 4
㸦㸱㸧㆑ูࢥ࣮ࢻ --------------------------------------------------------------------------------------------------------------- 4
㸦㸲㸧pHࠊᾐ㏱ᅽẚࠊ⢓ᗘࠊẚ㔜ࠊ↓⳦ࡢ᪨ཬࡧᏳᐃ࡞ pH ᇦ➼ ----------------------------------------------- 4
㸰㸬〇๣ࡢ⤌ᡂ
㸦㸯㸧᭷ຠᡂศ㸦άᛶᡂศ㸧ࡢྵ㔞 --------------------------------------------------------------------------------------- 4
㸦㸰㸧ῧຍ≀ --------------------------------------------------------------------------------------------------------------------- 4
㸦㸱㸧ࡑࡢ௚ --------------------------------------------------------------------------------------------------------------------- 4
㸱㸬ᠱ⃮๣ࠊங๣ࡢศᩓᛶ࡟ᑐࡍࡿὀព --------------------------------------------------------------------------------- 4
㸲㸬〇๣ࡢྛ✀᮲௳ୗ࡟࠾ࡅࡿᏳᐃᛶ ------------------------------------------------------------------------------------ 4
㸳㸬ㄪᩚἲཬࡧ⁐ゎᚋࡢᏳᐃᛶ --------------------------------------------------------------------------------------------- 4
㸴㸬௚๣࡜ࡢ㓄ྜኚ໬㸦≀⌮໬Ꮫⓗኚ໬㸧 ------------------------------------------------------------------------------ 4
㸵㸬⁐ฟᛶ ------------------------------------------------------------------------------------------------------------------------ 4
㸶㸬⏕≀Ꮫⓗヨ㦂ἲ ------------------------------------------------------------------------------------------------------------ 4
㸷㸬〇๣୰ࡢ᭷ຠᡂศࡢ☜ㄆヨ㦂ἲ --------------------------------------------------------------------------------------- 5
㸯㸮㸬〇๣୰ࡢ᭷ຠᡂศࡢᐃ㔞ἲ ------------------------------------------------------------------------------------------ 5
㸯㸯㸬ຊ౯ ------------------------------------------------------------------------------------------------------------------------ 5
㸯㸰㸬ΰධࡍࡿྍ⬟ᛶࡢ࠶ࡿ∝㞧≀ --------------------------------------------------------------------------------------- 5
㸯㸱㸬ὀពࡀᚲせ࡞ᐜჾ࣭እほࡀ≉Ṧ࡞ᐜჾ࡟㛵ࡍࡿ᝟ሗ --------------------------------------------------------- 5
㸯㸲㸬ࡑࡢ௚ --------------------------------------------------------------------------------------------------------------------- 5
㹔㸬἞⒪࡟㛵ࡍࡿ㡯┠
㸯㸬ຠ⬟ཪࡣຠᯝ --------------------------------------------------------------------------------------------------------------- 6
㸰㸬⏝ἲཬࡧᐜ㔞 --------------------------------------------------------------------------------------------------------------- 6
㸱㸬⮫ᗋᡂ⦼
㸦㸯㸧⮫ᗋࢹ࣮ࢱࣃࢵࢣ࣮ࢪ ------------------------------------------------------------------------------------------------ 6
㸦㸰㸧⮫ᗋຠᯝ ------------------------------------------------------------------------------------------------------------------ 6
㸦㸱㸧⮫ᗋ⸆⌮ヨ㦂 ------------------------------------------------------------------------------------------------------------ 6
㸦㸲㸧᥈⣴ⓗヨ㦂 --------------------------------------------------------------------------------------------------------------- 6
㸦㸳㸧᳨ドⓗヨ㦂
㸯㸧↓సⅭ໬୪⾜⏝㔞཯ᛂヨ㦂 -------------------------------------------------------------------------------------- 6
㸰㸧ẚ㍑ヨ㦂 -------------------------------------------------------------------------------------------------------------- 6
㸱㸧Ᏻ඲ᛶヨ㦂 ----------------------------------------------------------------------------------------------------------- 6
㸲㸧ᝈ⪅࣭⑓ែูヨ㦂 -------------------------------------------------------------------------------------------------- 6
㸦㸴㸧἞⒪ⓗ౑⏝
㸯㸧౑⏝ᡂ⦼ㄪᰝ࣭≉ᐃ౑⏝ᡂ⦼ㄪᰝ㸦≉ูㄪᰝ㸧
࣭〇㐀㈍኎ᚋ⮫ᗋヨ㦂㸦ᕷ㈍ᚋ⮫ᗋヨ㦂㸧------- 6
㸰㸧ᢎㄆ᮲௳࡜ࡋ࡚ᐇ᪋ணᐃࡢෆᐜཪࡣᐇ᪋ࡋࡓヨ㦂ࡢᴫせ ----------------------------------------------- 6
㹔,㸬⸆ຠ⸆⌮࡟㛵ࡍࡿ㡯┠
㸯㸬⸆⌮Ꮫⓗ࡟㛵㐃࠶ࡿ໬ྜ≀ཪࡣ໬ྜ≀⩌ --------------------------------------------------------------------------- 7
㸰㸬⸆⌮స⏝
㸦㸯㸧స⏝㒊఩࣭స⏝ᶵᗎ --------------------------------------------------------------------------------------------------- 7
㸦㸰㸧⸆ຠࢆ⿬௜ࡅࡿヨ㦂ᡂ⦼ --------------------------------------------------------------------------------------------- 7
㸦㸱㸧స⏝Ⓨ⌧᫬㛫࣭ᣢ⥆᫬㛫 --------------------------------------------------------------------------------------------- 7
㹔,,㸬⸆≀ືែ࡟㛵ࡍࡿ㡯┠
㸯㸬⾑୰⃰ᗘࡢ᥎⛣࣭ ᐃἲ
㸦㸯㸧἞⒪ୖ᭷ຠ࡞⾑୰⃰ᗘ ------------------------------------------------------------------------------------------------ 8
㸦㸰㸧᭱㧗⾑୰⃰ᗘ฿㐩᫬㛫 ------------------------------------------------------------------------------------------------ 8
㸦㸱㸧⮫ᗋヨ㦂࡛☜ㄆࡉࢀࡓ⾑୰⃰ᗘ ------------------------------------------------------------------------------------ 8
㸦㸲㸧୰ẘᇦ --------------------------------------------------------------------------------------------------------------------- 8
㸦㸳㸧㣗஦࣭ే⏝⸆ࡢᙳ㡪 --------------------------------------------------------------------------------------------------- 8
㸦㸴㸧ẕ㞟ᅋ㸦࣏ࣆ࣮ࣗࣞࢩࣙࣥ㸧ゎᯒ࡟ࡼࡾุ᫂ࡋࡓ⸆≀యෆືែኚືせᅉ ------------------------------ 9
㸰㸬⸆≀㏿ᗘㄽⓗࣃ࣓࣮ࣛࢱ
㸦㸯㸧ゎᯒ᪉ἲ ------------------------------------------------------------------------------------------------------------------ 9
㸦㸰㸧྾཰㏿ᗘᐃᩘ ------------------------------------------------------------------------------------------------------------ 9
㸦㸱㸧ࣂ࢖࢜࢔࣋࢖ࣛࣅࣜࢸ࢕ --------------------------------------------------------------------------------------------- 9
㸦㸲㸧ᾘኻ㏿ᗘᐃᩘ ------------------------------------------------------------------------------------------------------------ 9
㸦㸳㸧ࢡࣜ࢔ࣛࣥࢫ ------------------------------------------------------------------------------------------------------------ 9
㸦㸴㸧ศᕸᐜ✚ ------------------------------------------------------------------------------------------------------------------ 9
㸦㸵㸧⾑₢⺮ⓑ⤖ྜ⋡ --------------------------------------------------------------------------------------------------------- 9
㸱㸬྾཰ --------------------------------------------------------------------------------------------------------------------------- 9
㸲㸬ศᕸ
㸦㸯㸧⾑ᾮ㸫⬻㛵㛛㏻㐣ᛶ --------------------------------------------------------------------------------------------------- 9
㸦㸰㸧⾑ᾮ㸫⫾┙㛵㛛㏻㐣ᛶ ------------------------------------------------------------------------------------------------ 9
㸦㸱㸧ஙỒ࡬ࡢ⛣⾜ᛶ --------------------------------------------------------------------------------------------------------- 9
㸦㸲㸧㧊ᾮ࡬ࡢ⛣⾜ᛶ --------------------------------------------------------------------------------------------------------- 9
㸦㸳㸧ࡑࡢ௚ࡢ⤌⧊࡬ࡢ⛣⾜ᛶ --------------------------------------------------------------------------------------------- 9
㸳㸬௦ㅰ
㸦㸯㸧௦ㅰ㒊఩ཬࡧ௦ㅰ⤒㊰ ------------------------------------------------------------------------------------------------ 9
㸦㸰㸧௦ㅰ࡟㛵୚ࡍࡿ㓝⣲㸦CYP450 ➼㸧ࡢศᏊ✀ ------------------------------------------------------------------ 9
㸦㸱㸧ึᅇ㏻㐣ຠᯝࡢ᭷↓ཬࡧࡑࡢ๭ྜ --------------------------------------------------------------------------------- 9
㸦㸲㸧௦ㅰ≀ࡢάᛶࡢ᭷↓ཬࡧẚ⋡ --------------------------------------------------------------------------------------- 9
㸦㸳㸧άᛶ௦ㅰ≀ࡢ㏿ᗘㄽⓗࣃ࣓࣮ࣛࢱ -------------------------------------------------------------------------------- 10
㸴㸬᤼ἥ
㸦㸯㸧᤼ἥ㒊఩ཬࡧ⤒㊰ ----------------------------------------------------------------------------------------------------- 10
㸦㸰㸧᤼ἥ⋡ -------------------------------------------------------------------------------------------------------------------- 10
㸦㸱㸧᤼ἥ㏿ᗘ ----------------------------------------------------------------------------------------------------------------- 10
㸵㸬ࢺࣛࣥࢫ࣏࣮ࢱ࣮࡟㛵ࡍࡿ᝟ሗ -------------------------------------------------------------------------------------- 10
㸶㸬㏱ᯒ➼࡟ࡼࡿ㝖ཤ⋡ ----------------------------------------------------------------------------------------------------- 10
㹔,,,㸬Ᏻ඲ᛶ㸦౑⏝ୖࡢὀព➼㸧࡟㛵ࡍࡿ㡯┠
㸯㸬㆙࿌ෆᐜ࡜ࡑࡢ⌮⏤ ---------------------------------------------------------------------------------------------------- 11
㸰㸬⚗ᚷෆᐜ࡜ࡑࡢ⌮⏤㸦ཎ๎⚗ᚷࢆྵࡴ㸧 ------------------------------------------------------------------------- 11
㸱㸬ຠ⬟ཪࡣຠᯝ࡟㛵㐃ࡍࡿ౑⏝ୖࡢὀព࡜ࡑࡢ⌮⏤ ------------------------------------------------------------- 11
㸲㸬⏝ἲཬࡧ⏝㔞࡟㛵㐃ࡍࡿ౑⏝ୖࡢὀព࡜ࡑࡢ⌮⏤ ------------------------------------------------------------- 11
㸳㸬ៅ㔜ᢞ୚ෆᐜ࡜ࡑࡢ⌮⏤ ---------------------------------------------------------------------------------------------- 11
㸴㸬㔜せ࡞ᇶᮏⓗὀព࡜ࡑࡢ⌮⏤ཬࡧฎ⨨᪉ἲ ---------------------------------------------------------------------- 11
㸵㸬┦஫స⏝
㸦㸯㸧ే⏝⚗ᚷ࡜ࡑࡢ⌮⏤ ------------------------------------------------------------------------------------------------- 11
㸦㸰㸧ే⏝ὀព࡜ࡑࡢ⌮⏤ ------------------------------------------------------------------------------------------------- 11
㸶㸬๪స⏝
㸦㸯㸧๪స⏝ࡢᴫせ ---------------------------------------------------------------------------------------------------------- 11
㸦㸰㸧㔜኱࡞๪స⏝࡜ึᮇ⑕≧ ------------------------------------------------------------------------------------------- 11
㸦㸱㸧ࡑࡢ௚ࡢ๪స⏝ ------------------------------------------------------------------------------------------------------- 11
㸦㸲㸧㡯┠ู๪స⏝Ⓨ⌧㢖ᗘཬࡧ⮫ᗋ᳨ᰝ್␗ᖖ୍ぴ ------------------------------------------------------------- 12
㸦㸳㸧ᇶ♏⑌ᝈࠊྜే⑕ࠊ㔜⑕ᗘཬࡧᡭ⾡ࡢ᭷↓➼⫼ᬒูࡢ๪స⏝Ⓨ⌧㢖ᗘ ------------------------------- 12
㸦㸴㸧⸆≀࢔ࣞࣝࢠ࣮࡟ᑐࡍࡿὀពཬࡧヨ㦂ἲ ---------------------------------------------------------------------- 12
㸷㸬㧗㱋⪅࡬ࡢᢞ୚ ---------------------------------------------------------------------------------------------------------- 12
㸯㸮㸬ዷ፬ࠊ⏘፬ࠊᤵங፬➼࡬ࡢᢞ୚ ---------------------------------------------------------------------------------- 12
㸯㸯㸬ᑠඣ➼࡬ࡢᢞ୚ ------------------------------------------------------------------------------------------------------- 12
㸯㸰㸬⮫ᗋ᳨ᰝ⤖ᯝ࡟ཬࡰࡍᙳ㡪 ---------------------------------------------------------------------------------------- 12
㸯㸱㸬㐣㔞ᢞ୚ ---------------------------------------------------------------------------------------------------------------- 12
㸯㸲㸬㐺⏝ୖࡢὀព ---------------------------------------------------------------------------------------------------------- 12
㸯㸳㸬ࡑࡢ௚ࡢὀព ---------------------------------------------------------------------------------------------------------- 12
㸯㸴㸬ࡑࡢ௚ ------------------------------------------------------------------------------------------------------------------- 12
㹇㹖㸬㠀⮫ᗋヨ㦂࡟㛵ࡍࡿ㡯┠
㸯㸬⸆⌮ヨ㦂
㸦㸯㸧⸆ຠ⸆⌮ヨ㦂 ---------------------------------------------------------------------------------------------------------- 13
㸦㸰㸧๪ḟⓗ⸆⌮ヨ㦂 ------------------------------------------------------------------------------------------------------- 13
㸦㸱㸧Ᏻᐃᛶ⸆⌮ヨ㦂 ------------------------------------------------------------------------------------------------------- 13
㸦㸲㸧ࡑࡢ௚ࡢ⸆⌮ヨ㦂 ---------------------------------------------------------------------------------------------------- 13
㸰㸬ẘᛶヨ㦂
㸦㸯㸧༢ᅇᢞ୚ẘᛶヨ㦂 ---------------------------------------------------------------------------------------------------- 13
㸦㸰㸧཯᚟ᢞ୚ẘᛶヨ㦂 ---------------------------------------------------------------------------------------------------- 13
㸦㸱㸧⏕ṪⓎ⏕ẘᛶヨ㦂 ---------------------------------------------------------------------------------------------------- 13
㸦㸲㸧ࡑࡢ௚ࡢ≉Ṧẘᛶ ---------------------------------------------------------------------------------------------------- 13
㹖㸬⟶⌮ⓗ஦㡯࡟㛵ࡍࡿ㡯┠
㸯㸬つไ༊ศ ------------------------------------------------------------------------------------------------------------------- 14
㸰㸬᭷ຠᮇ㛫ཪࡣ౑⏝ᮇ㝈 ------------------------------------------------------------------------------------------------- 14
㸱㸬㈓ἲ࣭ಖᏑ᮲௳ ---------------------------------------------------------------------------------------------------------- 14
㸲㸬⸆๣ྲྀᢅ࠸ୖࡢὀពⅬ
㸦㸯㸧⸆ᒁ࡛ࡢྲྀࡾᢅ࠸࡟ࡘ࠸࡚ ---------------------------------------------------------------------------------------- 14
㸦㸰㸧⸆๣஺௜᫬ࡢὀព㸦ᝈ⪅➼࡟␃ពࡍ࡭ࡁᚲ㡲஦㡯➼㸧 ---------------------------------------------------- 14
㸦㸱㸧ㄪ๣᫬ࡢ␃ពⅬ࡟ࡘ࠸࡚ ------------------------------------------------------------------------------------------- 14
㸳㸬ᢎㄆ᮲௳➼ ---------------------------------------------------------------------------------------------------------------- 14
㸴㸬ໟ⿦ ------------------------------------------------------------------------------------------------------------------------- 14
㸵㸬ᐜჾࡢᮦ㉁ ---------------------------------------------------------------------------------------------------------------- 14
㸶㸬ྠ୍ᡂศ࣭ྠຠ⸆ ------------------------------------------------------------------------------------------------------- 14
㸷㸬ᅜ㝿ㄌ⏕ᖺ᭶᪥ ---------------------------------------------------------------------------------------------------------- 14
㸯㸮.〇㐀㈍኎ᢎㄆᖺ᭶᪥ཬࡧᢎㄆ␒ྕ --------------------------------------------------------------------------------- 14
㸯㸯.⸆౯ᇶ‽཰㍕ᖺ᭶᪥ --------------------------------------------------------------------------------------------------- 14
㸯㸰㸬ຠ⬟ཪࡣຠᯝ㏣ຍࠊ⏝ἲཬࡧ⏝㔞ኚ᭦࣭㏣ຍ➼ࡢᖺ᭶᪥ཬࡧࡑࡢෆᐜ ------------------------------- 14
㸯㸱㸬෌ᑂᰝ⤖ᯝࠊ෌ホ౯⤖ᯝබ⾲ᖺ᭶᪥ཬࡧࡑࡢෆᐜ ---------------------------------------------------------- 14
㸯㸲㸬෌ᑂᰝᮇ㛫 ------------------------------------------------------------------------------------------------------------- 14
㸯㸳㸬ᢞ୚ᮇ㛫ไ㝈་⸆ရ࡟㛵ࡍࡿ᝟ሗ ------------------------------------------------------------------------------- 15
㸯㸴㸬ྛ✀ࢥ࣮ࢻ ------------------------------------------------------------------------------------------------------------- 15
㸯㸵㸬ಖ㝤⤥௜ୖࡢὀព ---------------------------------------------------------------------------------------------------- 15
㹖㹇㸬ᩥ⊩
㸯㸬ᘬ⏝ᩥ⊩ ------------------------------------------------------------------------------------------------------------------- 16
㸰㸬ࡑࡢ௚ࡢཧ⪃ᩥ⊩ ------------------------------------------------------------------------------------------------------- 16
㹖㹇㹇㸬ཧ⪃㈨ᩱ
㸯㸬୺࡞እᅜ࡛ࡢⓎ኎≧ἣ ------------------------------------------------------------------------------------------------- 17
㸰㸬ᾏእ࡟࠾ࡅࡿ⮫ᗋᨭ᥼᝟ሗ ------------------------------------------------------------------------------------------- 17
㹖㹇㹇㹇㸬ഛ⪃
ࡑࡢ௚ࡢ㛵㐃㈨ᩱ ------------------------------------------------------------------------------------------------------------- 18
㹇㸬ᴫせ࡟㛵ࡍࡿ㡯┠
㸯㸬㛤Ⓨࡢ⤒⦋
ࢥࢺࣈ࣮ࣟࣝ㘄 15mg ࡣࠊ1992 ᖺ 2 ᭶ 29 ᪥࡟ᑑ〇⸆ᰴᘧ఍♫࡛〇㐀㈍኎
ᢎㄆࢆྲྀᚓࡋࠊ1992 ᖺ 7 ᭶ 10 ᪥࡟⸆౯ᇶ‽཰㍕ࡉࢀࡓࢥࢺࣈ࣮ࣟࣝ㘄ࡢ
㈍኎ྡኚ᭦ရ࡛࠶ࡾࠊ2008 ᖺ 3 ᭶ 6 ᪥࡟ᑑ〇⸆ᰴᘧ఍♫࡛〇㐀㈍኎ᢎㄆ
ࢆྲྀᚓࡋࠊ2008 ᖺ 6 ᭶࡟⸆౯ᇶ‽཰㍕ࡉࢀࡓ〇ရ࡛࠶ࡿࠋ
㸰㸬〇ရࡢ἞⒪Ꮫⓗ࣭〇๣Ꮫ
ⓗ≉ᛶ
࣭Ẽ㐨ᾮࡢศἪࢆಁ㐍ࡍࡿࡇ࡜࡟ࡼࡾࠊẼ㐨ቨࢆ⁥ࡾࡸࡍࡃࡍࡿࠋ
࣭⫵⾲㠃άᛶ≀㉁ࡢศἪಁ㐍࡟స⏝࡟ࡼࡾࠊ⫵⬊ࡸ࿧྾⣽Ẽ⟶ᨭࢆࢡ࣮ࣜ
ࢽࣥࢢࡍࡿࠋ
࣭⥺ẟ㐠ືࢆஹ㐍ࡋࠊẼ㐨ቨࢆ₶⁥࡟ࡋ࡚ࠊၻ⑱࣭ၻฟࢆಁ㐍ࡍࡿࠋ
,,㸬ྡ⛠࡟㛵ࡍࡿ㡯┠
㸯.㈍኎ྡ
㸦㸯㸧࿴ྡ
ࢥࢺࣈ࣮ࣟࣝ㘄 15mg
㸦㸰㸧ὒྡ
KOTOBULOL TAB. 15mg
㸦㸱㸧ྡ⛠ࡢ⏤᮶
≉࡟࡞ࡋ
㸰㸬୍⯡ྡ
㸦㸯㸧࿴ྡ㸦࿨ྡἲ㸧
࢔ࣥࣈࣟ࢟ࢯ࣮ࣝሷ㓟ሷ㸦INN㸧
㸦㸰㸧ὒྡ㸦࿨ྡἲ㸧
Ambroxol Hydrochloride㸦INN㸧
㸦㸱㸧ࢫࢸ࣒
୙᫂
㸱㸬ᵓ㐀ᘧཪࡣ♧ᛶᘧ
㸲㸬ศᏊᘧཬࡧศᏊ㔞
ศᏊᘧ㸸C13H18Br2N2O࣭HCl
ศᏊ㔞㸸414.56
㸳㸬໬Ꮫྡ㸦࿨ྡἲ㸧
trans-4-[(2-amino-3, 5-dibromobenzyl) amino] cyclohexanol
hydrochloride㸦IUPAC ࿨ྡἲ࡟ࡼࡿ㸧
㸴㸬័⏝ྡࠊูྡࠊ␎ྕࠊグ
ྕ␒ྕ
≉࡟࡞ࡋ
㸵㸬CAS Ⓩ㘓␒ྕ
18683-91-5
,,,㸬᭷ຠᡂศ࡟㛵ࡍࡿ㡯┠
㸯㸬≀⌮໬Ꮫⓗᛶ㉁
㸦㸯㸧እほ࣭ᛶ≧
ⓑⰍࡢ⤖ᬗᛶࡢ⢊ᮎ࡛ࠊ࡟࠾࠸ࡣ࡞ࡃࠊࢃࡎ࠿࡟≉␗࡞࿡ࡀ࠶ࡿࠋ
㸦㸰㸧⁐ゎᛶ
࣓ࢱࣀ࣮ࣝ࡟ࡸࡸ⁐ࡅࡸࡍࡃࠊỈཪࡣ࢚ࢱࣀ࣮ࣝ㸦99.5㸧࡟ࡸࡸ⁐ࡅ࡟ࡃ
ࡃࠊ㓑㓟㸦100㸧࡟⁐ࡅ࡟ࡃࡃࠊࢪ࢚ࢳ࢚࣮ࣝࢸࣝ࡟࡯࡜ࢇ࡝⁐ࡅ࡞࠸ࠋ
㸦㸱㸧྾‵ᛶ
྾‵ᛶࡣࡳࡽࢀ࡞࠸ࠋ
㸦㸲㸧⼥Ⅼ㸦ศゎⅬ㸧
ࠊἛⅬࠊ ⼥Ⅼ㸸235Υ(ศゎ)
จᅛⅬ
㸦㸳㸧㓟ሷᇶゎ㞳ᐃᩘ
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸴㸧ศ㓄ಀᩘ
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸵㸧ࡑࡢ௚ࡢ୺࡞♧ᛶ್
ヱᙜ㈨ᩱ࡞ࡋ
㸰㸬᭷ຠᡂศࡢྛ✀᮲௳ୗ࡟
࠾ࡅࡿᏳᐃᛶ
ヱᙜ㈨ᩱ࡞ࡋ
㸱㸬᭷ຠᡂศࡢ☜ㄆヨ㦂ἲ
㸦1㸧࿊Ⰽ཯ᛂ
㸦2㸧⣸እྍど྾ගᗘ ᐃἲ㸦ᴟ኱྾཰Ἴ㛗㸸243㹼247nm, 306㹼310nm㸧
㸦3㸧᪥ᒁ୍⯡ヨ㦂ἲࠕ㉥እ྾཰ࢫ࣌ࢡࢺࣝ ᐃἲ㸦⮯໬࣒࢝ࣜ࢘㘄๣ἲ㸧ࠖ
㸦4㸧᪥ᒁ୍⯡ヨ㦂ἲࠕᐃᛶ཯ᛂ㸦ሷ໬≀㸧ࠖ
㸲㸬᭷ຠᡂศࡢᐃ㔞ἲ
0.1mol/L 㐣ሷ⣲㓟࡟ࡼࡿ⁲ᐃ㸦㟁఩ᕪ⁲ᐃἲ㸧
㹇㹔㸬〇๣࡟㛵ࡍࡿ㡯┠
㸯㸬๣ᙧ
㸦㸯㸧๣ᙧࡢ༊ูࠊእほཬࡧ
ᛶ≧
ⓑⰍࡢ๭⥺ධࡾ⣲㘄
Ⰽ࣭๣ᙧ
⾲㠃
⿬㠃
ഃ㠃
┤ᚄ㸦mm㸧
ཌࡉ㸦mm㸧
㔜㔞㸦mg㸧
7.0
2.4
120
እᙧ
኱ࡁࡉ
㸦㸰㸧〇๣ࡢ≀ᛶ
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸱㸧㆑ูࢥ࣮ࢻ
KTB 42
㸦㸲㸧pHࠊᾐ㏱ᅽẚࠊ⢓ᗘࠊ ヱᙜ㈨ᩱ࡞ࡋ
ẚ㔜ࠊ↓⳦ࡢ᪨ཬࡧᏳ
ᐃ࡞ pH ᇦ➼
㸰㸬〇๣ࡢ⤌ᡂ
㸦㸯㸧᭷ຠᡂศ㸦άᛶᡂศ㸧
ࡢྵ㔞
1 㘄୰࢔ࣥࣈࣟ࢟ࢯ࣮ࣝሷ㓟ሷ 15mg
㸦㸰㸧ῧຍ≀
ங⢾Ỉ࿴≀ࠊ⤖ᬗࢭ࣮ࣝࣟࢫࠊࢺ࢘ࣔࣟࢥࢩࢹࣥࣉࣥࠊࣄࢻࣟ࢟ࢩࣉࣟࣆ
ࣝࢭ࣮ࣝࣟࢫࠊࢫࢸ࢔ࣜࣥ㓟 Mg
㸦㸱㸧ࡑࡢ௚
≉࡟࡞ࡋ
㸱㸬ᠱ⃮๣ࠊங๣ࡢศᩓᛶ࡟
ᑐࡍࡿὀព
ヱᙜࡋ࡞࠸
㸲㸬〇๣ࡢྛ✀᮲௳ୗ࡟࠾ࡅ
ࡿᏳᐃᛶ㸱㸧
᭱⤊ໟ⿦〇ရࢆ⏝࠸ࡓຍ㏿ヨ㦂(40Υࠊ┦ᑐ‵ᗘ 75%ࠊ6 ࣧ᭶) ࡢ⤖ᯝࠊࢥ
ࢺࣈ࣮ࣟࣝ㘄 15mg ࡣ㏻ᖖࡢᕷሙὶ㏻ୗ࡟࠾࠸࡚ 3 ᖺ㛫Ᏻᐃ࡛࠶ࡿࡇ࡜ࡀ
᥎ ࡉࢀࡓࠋ
㸳㸬ㄪᩚἲཬࡧ⁐ゎᚋࡢᏳᐃᛶ
ヱᙜ㈨ᩱ࡞ࡋ
㸴㸬௚๣࡜ࡢ㓄ྜኚ໬㸦≀⌮
໬Ꮫⓗኚ໬㸧
ヱᙜ㈨ᩱ࡞ࡋ
㸵㸬⁐ฟᛶ㸰㸧
ࢥࢺࣈ࣮ࣟࣝ㘄 15mg ࡣࠊ᪥ᮏ⸆ᒁ᪉እ་⸆ရつ᱁➨ 3 㒊࡟ᐃࡵࡽࢀࡓሷ
㓟࢔ࣥࣈࣟ࢟ࢯ࣮ࣝ㘄ࡢ⁐ฟつ᱁࡟㐺ྜࡋ࡚࠸ࡿࡇ࡜ࡀ☜ㄆࡉࢀ࡚࠸ࡿࠋ
㸶㸬⏕≀Ꮫⓗヨ㦂ἲ
ヱᙜࡋ࡞࠸
㸷㸬〇๣୰ࡢ᭷ຠᡂศࡢ☜ㄆ
ヨ㦂ἲ
㸦1㸧࿊Ⰽ཯ᛂ
㸦2㸧᪥ᒁ୍⯡ヨ㦂ἲࠕᐃᛶ཯ᛂ㸦ሷ໬≀㸧ࠖ
㸦3㸧᪥ᒁ୍⯡ヨ㦂ἲࠕᐃᛶ཯ᛂ㸦⮯໬≀㸧ࠖ
㸦4㸧⣸እྍど྾ගᗘ ᐃἲ㸦ᴟ኱྾཰Ἴ㛗㸸243㹼247nm, 306㹼310nm㸧
㸦5㸧᪥ᒁ୍⯡ヨ㦂ἲࠕⷧᒙࢡ࣐ࣟࢺࢢࣛࣇἲࠖ
㸯㸮㸬〇๣୰ࡢ᭷ຠᡂศࡢᐃ
㔞ἲ
⣸እྍど྾ගᗘ ᐃἲ
㸯㸯㸬ຊ౯
ヱᙜࡋ࡞࠸
㸯㸰㸬ΰධࡍࡿྍ⬟ᛶࡢ࠶ࡿ
ዃ㞧≀
ヱᙜ㈨ᩱ࡞ࡋ
㸯㸱㸬ὀពࡀᚲせ࡞ᐜჾ࣭እ
ほࡀ≉Ṧ࡞ᐜჾ࡟㛵ࡍ
ࡿ᝟ሗ
ヱᙜ㈨ᩱ࡞ࡋ
㸯㸲㸬ࡑࡢ௚
≉࡟࡞ࡋ
㹔㸬἞⒪࡟㛵ࡍࡿ㡯┠
㸯㸬ຠ⬟ཪࡣຠᯝ
ୗグ⑌ᝈࡢཤ⑱
ᛴᛶẼ⟶ᨭ⅖ࠊẼ⟶ᨭႍᜥࠊ៏ᛶẼ⟶ᨭ⅖ࠊẼ⟶ᨭᣑᙇ⑕ࠊ⫵⤖᰾ࠊሻ
⫵⑕ࠊᡭ⾡ᚋࡢၻ⑱ၻฟᅔ㞴
៏ᛶ๪㰯⭍⅖ࡢ᤼⮋
㸰㸬⏝ἲཬࡧ⏝㔞
㏻ᖖࠊᡂே࡟ࡣ 1 ᅇ 1 㘄㸦࢔ࣥࣈࣟ࢟ࢯ࣮ࣝሷ㓟ሷ࡜ࡋ࡚ 15mg㸧ࢆ 1 ᪥
3 ᅇ⤒ཱྀᢞ୚ࡍࡿࠋ
࡞࠾ࠊᖺ㱋࣭⑕≧࡟ࡼࡾ㐺ᐅቑῶࡍࡿࠋ
㸱㸬⮫ᗋᡂ⦼
㸦㸯㸧⮫ᗋࢹ࣮ࢱࣃࢵࢣ࣮ࢪ
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸰㸧⮫ᗋຠᯝ
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸱㸧⮫ᗋ⸆⌮ヨ㦂
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸲㸧᥈⣴ⓗヨ㦂
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸳㸧᳨ドⓗヨ㦂
㸯㸧↓సⅭ໬୪⾜⏝㔞཯
ᛂヨ㦂
ヱᙜ㈨ᩱ࡞ࡋ
㸰㸧ẚ㍑ヨ㦂
ヱᙜ㈨ᩱ࡞ࡋ
㸱㸧Ᏻ඲ᛶヨ㦂
ヱᙜ㈨ᩱ࡞ࡋ
㸲㸧ᝈ⪅㺃⑓ែูヨ㦂
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸴㸧἞⒪ⓗ౑⏝
㸯㸧౑⏝ᡂ⦼ㄪᰝ࣭≉ᐃ
౑⏝ᡂ⦼ㄪᰝ㸦≉ู
ㄪᰝ㸧
࣭〇㐀㈍኎ᚋ⮫
ᗋヨ㦂㸦ᕷ㈍ᚋ⮫ᗋ
ヨ㦂㸧
㸰㸧ᢎㄆ᮲௳࡜ࡋ࡚ᐇ᪋
ணᐃࡢෆᐜཪࡣᐇ᪋
ࡋࡓヨ㦂ࡢᴫせ
ヱᙜ㈨ᩱ࡞ࡋ
ヱᙜ㈨ᩱ࡞ࡋ
㹔,㸬⸆ຠ⸆⌮࡟㛵ࡍࡿ㡯┠
㸯㸬⸆⌮Ꮫⓗ࡟㛵㐃࠶ࡿ໬ྜ
≀ཪࡣ໬ྜ≀⩌
㸰㸬⸆⌮స⏝
㸦㸯㸧స⏝㒊఩࣭స⏝ᶵᗎ
ሷ㓟ࣈ࣒ࣟ࣊࢟ࢩࣥ
స⏝㒊఩㸸Ẽ㐨ࠊ⫵
స⏝ᶵᗎ㸸ヱᙜ㈨ᩱ࡞ࡋ
㸦㸰㸧⸆ຠࢆ⿬௜ࡅࡿヨ㦂ᡂ⦼
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸱㸧స⏝Ⓨ⌧᫬㛫࣭ᣢ⥆᫬㛫
ヱᙜ㈨ᩱ࡞ࡋ
㹔,,㸬⸆≀ືែ࡟㛵ࡍࡿ㡯┠
㸯㸬⾑୰⃰ᗘࡢ᥎⛣࣭ ᐃἲ
㸦㸯㸧἞⒪ୖ᭷ຠ࡞⾑୰⃰ᗘ
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸰㸧᭱㧗⾑୰⃰ᗘ฿㐩᫬㛫
ᢞ୚ᚋ⣙ 2 ᫬㛫
㸦㸱㸧⮫ᗋヨ㦂࡛☜ㄆࡉࢀࡓ
⾑୰⃰ᗘ㸯㸧
㸺⏕≀Ꮫⓗྠ➼ᛶヨ㦂㸼
ࢥࢺࣈ࣮ࣟࣝ㘄 15mg ࡜ᶆ‽〇๣ࢆࠊࢡࣟࢫ࣮࢜ࣂ࣮ἲ࡟ࡼࡾࡑࢀࡒࢀ 1
㘄㸦࢔ࣥࣈࣟ࢟ࢯ࣮ࣝሷ㓟ሷ 15mg㸧೺ᗣᡂே⏨Ꮚ࡟⤯㣗༢ᅇ⤒ཱྀᢞ୚ࡋ
࡚⾑₢୰ᮍኚ໬య⃰ᗘࢆ ᐃࡋࠊᚓࡽࢀࡓ⸆≀ືែࣃ࣓࣮ࣛࢱ㸦AUCtࠊ
Cmax㸧࡟ࡘ࠸࡚⤫ィゎᯒࢆ⾜ࡗࡓ⤖ᯝࠊ୧๣ࡢ⏕≀Ꮫⓗྠ➼ᛶࡀ☜ㄆࡉ
ࢀࡓࠋ
AUCt
(ng㺃hr/mL)
Cmax
(ng/mL)
Tmax
(hr)
t1/2
(hr)
75.6 ± 13.7
9.7 ± 2.1
1.7 ± 0.5
7.3 ± 2.2
ᶆ‽〇๣
74.2 ± 15.4
㸦㘄๣ࠊ15mg㸧
9.9 ± 3.6
1.8 ± 0.5
6.9 ± 2.8
ࢥࢺࣈ࣮ࣟࣝ
㘄 15mg
㸦MeansS.D., n=12㸧
⾑₢୰⃰ᗘ୪ࡧ࡟ AUCtࠊCmax ➼ࡢࣃ࣓࣮ࣛࢱࡣࠊ⿕㦂⪅ࡢ㑅ᢥࠊయᾮ
ࡢ᥇ྲྀᅇᩘ࣭᫬㛫➼ࡢヨ㦂᮲௳࡟ࡼࡗ࡚␗࡞ࡿྍ⬟ᛶࡀ࠶ࡿࠋ
㸦㸲㸧୰ẘᇦ
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸳㸧㣗஦࣭ే⏝⸆ࡢᙳ㡪
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸴㸧ẕ㞟ᅋ㸦࣏ࣆ࣮ࣗࣞࢩ
ࣙࣥ㸧ゎᯒ࡟ࡼࡾุ᫂
ࡋࡓ⸆≀యෆືែኚື
せᅉ
ヱᙜ㈨ᩱ࡞ࡋ
㸰㸬⸆≀㏿ᗘㄽⓗࣃ࣓࣮ࣛࢱ
㸦㸯㸧ゎᯒ᪉ἲ
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸰㸧྾཰㏿ᗘᐃᩘ
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸱㸧ࣂ࢖࢜࢔࣋࢖ࣛࣅࣜࢸ࢕ ヱᙜ㈨ᩱ࡞ࡋ
㸦㸲㸧ᾘኻ㏿ᗘᐃᩘ
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸳㸧ࢡࣜ࢔ࣛࣥࢫ
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸴㸧ศᕸᐜ✚
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸵㸧⾑₢⺮ⓑ⤖ྜ⋡
ヱᙜ㈨ᩱ࡞ࡋ
㸱㸬྾཰
ヱᙜ㈨ᩱ࡞ࡋ
㸲㸬ศᕸ
㸦㸯㸧⾑ᾮ㸫⬻㛵㛛㏻㐣ᛶ
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸰㸧⾑ᾮ㸫⫾┙㛵㛛㏻㐣ᛶ
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸱㸧ஙỒ࡬ࡢ⛣⾜ᛶ
㸦
ࠕ㹔㹇㹇㹇㸬Ᏻ඲ᛶ㸦౑⏝ୖࡢὀព➼㸧࡟㛵ࡍࡿ㡯┠ 㸯㸮㸬ዷ፬ࠊ⏘
፬ࠊᤵங፬➼࡬ࡢᢞ୚ࠖࡢ㡯ཧ↷㸧
㸦㸲㸧㧊ᾮ࡬ࡢ⛣⾜ᛶ
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸳㸧ࡑࡢ௚ࡢ⤌⧊࡬ࡢ⛣⾜ᛶ
ヱᙜ㈨ᩱ࡞ࡋ
㸳㸬௦ㅰ
㸦㸯㸧௦ㅰ㒊఩ཬࡧ௦ㅰ⤒㊰
ヱᙜ㈨ᩱ࡞ࡋ
㸦 㸰㸧௦ ㅰ࡟㛵 ୚ࡍࡿ 㓝⣲
㸦CYP450 ➼㸧ࡢศᏊ✀
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸱㸧ึᅇ㏻㐣ຠᯝࡢ᭷↓ཬ
ヱᙜ㈨ᩱ࡞ࡋ
ࡧࡑࡢ๭ྜ
㸦㸲㸧௦ㅰ≀ࡢάᛶࡢ᭷↓ཬ
ࡧẚ⋡
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸳㸧άᛶ௦ㅰ≀ࡢ㏿ᗘㄽⓗ
ࣃ࣓࣮ࣛࢱ
ヱᙜ㈨ᩱ࡞ࡋ
㸴㸬᤼ἥ
㸦㸯㸧᤼ἥ㒊఩ཬࡧ⤒㊰
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸰㸧᤼ἥ⋡
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸱㸧᤼ἥ㏿ᗘ
ヱᙜ㈨ᩱ࡞ࡋ
㸵㸬ࢺࣛࣥࢫ࣏࣮ࢱ࣮࡟㛵ࡍ
ࡿ᝟ሗ
ヱᙜ㈨ᩱ࡞ࡋ
㸶㸬㏱ᯒ➼࡟ࡼࡿ㝖ཤ⋡
ヱᙜ㈨ᩱ࡞ࡋ
㹔,,,㸬Ᏻ඲ᛶ㸦౑⏝ୖࡢὀព➼㸧࡟㛵ࡍࡿ㡯┠
㸯㸬㆙࿌ෆᐜ࡜ࡑࡢ⌮⏤
ヱᙜࡋ࡞࠸
㸰㸬⚗ᚷෆᐜ࡜ࡑࡢ⌮⏤㸦ཎ
๎⚗ᚷࢆྵࡴ㸧
ᮏ๣ࡢᡂศ࡟ᑐࡋ㐣ᩄ⑕ࡢ᪤ Ṕࡢ࠶ࡿᝈ⪅
㸱㸬ຠ⬟ཪࡣຠᯝ࡟㛵㐃ࡍࡿ
౑⏝ୖࡢὀព࡜ࡑࡢ⌮⏤
ヱᙜࡋ࡞࠸
㸲㸬⏝ἲཬࡧ⏝㔞࡟㛵㐃ࡍࡿ
౑⏝ୖࡢὀព࡜ࡑࡢ⌮⏤
ヱᙜࡋ࡞࠸
㸳㸬ៅ㔜ᢞ୚ෆᐜ࡜ࡑࡢ⌮⏤
ヱᙜࡋ࡞࠸
㸴㸬㔜せ࡞ᇶᮏⓗὀព࡜ࡑࡢ
⌮⏤ཬࡧฎ⨨᪉ἲ
ヱᙜࡋ࡞࠸
㸵㸬┦஫స⏝
㸦㸯㸧ే⏝⚗ᚷ࡜ࡑࡢ⌮⏤
㸦㸰㸧ే⏝ὀព࡜ࡑࡢ⌮⏤
㸶㸬๪స⏝
㸦㸯㸧๪స⏝ࡢᴫせ
ヱᙜࡋ࡞࠸
ヱᙜࡋ࡞࠸
ᮏ๣ࡣࠊ౑⏝ᡂ⦼ㄪᰝ➼ࡢ๪స⏝Ⓨ⌧㢖ᗘࡀ᫂☜࡜࡞ࡿㄪᰝࢆᐇ᪋ࡋ࡚࠸
࡞࠸ࠋ
㸦㸰㸧㔜኱࡞๪స⏝࡜ึᮇ⑕≧
1㸧ࢩ
ࢩࣙࢵࢡࠊ࢔ࢼࣇ࢕ࣛ࢟ࢩ࣮ ࢩࣙࢵࢡࠊ࢔ࢼࣇ࢕ࣛ࢟ࢩ࣮㸦Ⓨ⑈ࠊ
㢦㠃ᾋ⭘ࠊ࿧྾ᅔ㞴ࠊ⾑ᅽపୗ➼㸧ࡀ࠶ࡽࢃࢀࡿࡇ࡜ࡀ࠶ࡿࡢ࡛ࠊほᐹ
ࢆ༑ศ࡟⾜࠸ࠊ␗ᖖࡀㄆࡵࡽࢀࡓሙྜ࡟ࡣࠊᢞ୚ࢆ୰Ṇࡋࠊ㐺ษ࡞ฎ⨨
ࢆ⾜࠺ࡇ࡜ࠋ
2㸧⓶
⓶⭵⢓⭷║⑕ೃ⩌㸦Stevens-Johnson ⑕ೃ⩌㸧 ⓶⭵⢓⭷║⑕ೃ⩌
㸦Stevens-Johnson ⑕ೃ⩌㸧ࡀ࠶ࡽࢃࢀࡿࡇ࡜ࡀ࠶ࡿࡢ࡛ࠊほᐹࢆ༑ศ
࡟⾜࠸ࠊ␗ᖖࡀㄆࡵࡽࢀࡓሙྜ࡟ࡣࠊᢞ୚ࢆ୰Ṇࡋࠊ㐺ษ࡞ฎ⨨ࢆ⾜࠺
ࡇ࡜ࠋ
㸦㸱㸧ࡑࡢ௚ࡢ๪స⏝
௨ୗࡢࡼ࠺࡞๪స⏝ࡀ࠶ࡽࢃࢀࡓሙྜ࡟ࡣࠊ⑕≧࡟ᛂࡌ࡚㐺ษ࡞ฎ⨨ࢆ⾜
࠺ࡇ࡜ࠋ
㢖ᗘ୙᫂
ᾘ໬ჾ
⫢⮚
㐣ᩄ⑕㸨1
⫶୙ᛌឤࠊ⫶③ࠊ⭡㒊⭾‶ឤࠊ⭡③ࠊୗ⑩ࠊ჎Ẽࠊ჎
ྤࠊ౽⛎ࠊ㣗ᛮ୙᣺ࠊᾘ໬୙Ⰻ㸦⫶㒊⭾‶ឤࠊ⬚ࡸࡅ
➼㸧
⫢ᶵ⬟㞀ᐖࠝAST㸦GOT㸧ୖ᪼ࠊALT㸦GPT㸧ୖ᪼➼ࠞ
⾑⟶ᾋ⭘㸦㢦㠃ᾋ⭘ࠊ║▛ᾋ⭘ࠊཱྀ၁ᾋ⭘➼㸧ࠊⓎ⑈ࠊ
ⶼ㯞⑈ࠊⶼ㯞⑈ᵝ⣚ᩬࠊ⒍⑛
ࡑࡢ௚
ࡵࡲ࠸ࠊཱྀෆࡋࡧࢀឤࠊୖ⫥ࡢࡋࡧࢀឤ
㸨1 ࡇࡢࡼ࠺࡞⑕≧ࡀ࠶ࡽࢃࢀࡓሙྜ࡟ࡣࠊᢞ୚ࢆ୰Ṇࡍࡿࡇ࡜ࠋ
㸦㸲㸧㡯┠ู๪స⏝Ⓨ⌧㢖ᗘ ヱᙜ㈨ᩱ࡞ࡋ
ཬࡧ⮫ᗋ᳨ᰝ್␗ᖖ୍ぴ
㸦㸳㸧ᇶ♏⑌ᝈࠊྜే⑕ࠊ㔜 ヱᙜ㈨ᩱ࡞ࡋ
⑕ᗘཬࡧᡭ⾡ࡢ᭷↓➼
⫼ᬒูࡢ๪స⏝Ⓨ⌧㢖ᗘ
㸦㸴㸧⸆≀࢔ࣞࣝࢠ࣮࡟ᑐࡍ
ࡿὀពཬࡧヨ㦂ἲ
ヱᙜ㈨ᩱ࡞ࡋ
㸷㸬㧗㱋⪅࡬ࡢᢞ୚
୍⯡࡟㧗㱋⪅࡛ࡣ⏕⌮ᶵ⬟ࡀపୗࡋ࡚࠸ࡿࡢ࡛ῶ㔞ࡍࡿ࡞࡝ὀពࡍࡿࡇ
࡜ࠋ
㸯㸮㸬ዷ፬ࠊ⏘፬ࠊᤵங፬➼
࡬ࡢᢞ୚
㸦1㸧ዷ፬ཪࡣዷፎࡋ࡚࠸ࡿྍ⬟ᛶࡢ࠶ࡿ፬ே࡟ࡣࠊ἞⒪ୖࡢ᭷┈ᛶࡀ༴
㝤ᛶࢆୖᅇࡿ࡜ุ᩿ࡉࢀࡿሙྜ࡟ࡢࡳᢞ୚ࡍࡿࡇ࡜ࠋ㸦ዷፎ୰ࡢᢞ୚
࡟㛵ࡍࡿᏳ඲ᛶࡣ☜❧ࡋ࡚࠸࡞࠸ࠋ
㸧
㸦2㸧ᤵங୰ࡢ፬ே࡟ࡣᮏ๣ᢞ୚୰ࡣᤵஙࢆ㑊ࡅࡉࡏࡿࡇ࡜ࠋࠝື≀ᐇ㦂
㸦ࣛࢵࢺ㸧࡛ẕங୰࡬⛣⾜ࡍࡿࡇ࡜ࡀሗ࿌ࡉࢀ࡚࠸ࡿࠋ
ࠞ
㸯㸯㸬ᑠඣ➼࡬ࡢᢞ୚
ヱᙜ㈨ᩱ࡞ࡋ
㸯㸰㸬⮫ᗋ᳨ᰝ⤖ᯝ࡟ཬࡰࡍ
ᙳ㡪
ヱᙜ㈨ᩱ࡞ࡋ
㸯㸱㸬㐣㔞ᢞ୚
ヱᙜ㈨ᩱ࡞ࡋ
㸯㸲㸬㐺⏝ୖࡢὀព
⸆๣஺௜᫬ PTP ໟ⿦ࡢ⸆๣ࡣ PTP ࢩ࣮ࢺ࠿ࡽྲྀࡾฟࡋ࡚᭹⏝ࡍࡿࡼ࠺
ᣦᑟࡍࡿࡇ࡜ࠋ
㸦PTP ࢩ࣮ࢺࡢㄗ㣧࡟ࡼࡾࠊ◳࠸㗦ゅ㒊ࡀ㣗㐨⢓⭷࡬่
ධࡋࠊ᭦࡟ࡣ✸Ꮝࢆ㉳ࡇࡋ࡚⦪㝸Ὕ⅖➼ࡢ㔜⠜࡞ྜే⑕ࢆేⓎࡍࡿࡇ࡜
ࡀሗ࿌ࡉࢀ࡚࠸ࡿࠋ㸧
㸯㸳㸬ࡑࡢ௚ࡢὀព
ヱᙜࡋ࡞࠸
㸯㸴㸬ࡑࡢ௚
ヱᙜࡋ࡞࠸
,㹖㸬㠀⮫ᗋヨ㦂࡟㛵ࡍࡿ㡯┠
㸯㸬⸆⌮ヨ㦂
㸦㸯㸧⸆ຠ⸆⌮ヨ㦂
㸦
ࠕ㹔㹇㸬⸆ຠ⸆⌮࡟㛵ࡍࡿ㡯┠ࠖࡢ㡯ཧ↷㸧
㸦㸰㸧๪ḟⓗ⸆⌮ヨ㦂
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸱㸧Ᏻᐃᛶ⸆⌮ヨ㦂
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸲㸧ࡑࡢ௚ࡢ⸆⌮ヨ㦂
ヱᙜ㈨ᩱ࡞ࡋ
㸰㸬ẘᛶヨ㦂
㸦㸯㸧༢ᅇᢞ୚ẘᛶヨ㦂
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸰㸧཯᚟ᢞ୚ẘᛶヨ㦂
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸱㸧⏕ṪⓎ⏕ẘᛶヨ㦂
ヱᙜ㈨ᩱ࡞ࡋ
㸦㸲㸧ࡑࡢ௚ࡢ≉Ṧẘᛶ
ヱᙜ㈨ᩱ࡞ࡋ
㹖㸬⟶⌮ⓗ஦㡯࡟㛵ࡍࡿ㡯┠
㸯㸬つไ༊ศ
ヱᙜࡋ࡞࠸
㸰㸬᭷ຠᮇ㛫ཪࡣ౑⏝ᮇ㝈
3 ᖺ㸦እ⟽࡟⾲♧ࡢ౑⏝ᮇ㝈ෆ࡟౑⏝ࡍࡿࡇ࡜ࠋ
㸧
㸱㸬㈓ἲ࣭ಖᏑ᮲௳
㐽ගẼᐦᐜჾಖᏑ
㸲㸬⸆๣ྲྀᢅ࠸ୖࡢὀពⅬ
㸦㸯㸧⸆ᒁ࡛ࡢྲྀࡾᢅ࠸࡟ࡘ
࠸࡚
ヱᙜࡋ࡞࠸
㸦㸰㸧⸆๣஺௜᫬ࡢὀព㸦ᝈ
⪅➼࡟␃ពࡍ࡭ࡁᚲ㡲
஦㡯➼㸧
㸦
ࠕ㹔㹇㹇㹇㸬Ᏻᐃᛶ㸦౑⏝ୖࡢὀព➼㸧࡟㛵ࡍࡿ㡯┠ 㸯㸲㸬㐺⏝ୖࡢ
㸦㸱㸧ㄪ๣᫬ࡢ␃ពⅬ࡟ࡘ࠸࡚
ヱᙜࡋ࡞࠸
㸳㸬ᢎㄆ᮲௳➼
ヱᙜࡋ࡞࠸
㸴㸬ໟ⿦
㸦PTP ໟ⿦㸧100 㘄
㸵㸬ᐜჾࡢᮦ㉁
㹙PTP ໟ⿦ရ㹛
PTP ໟ⿦㸸◳㉁ሷ໬ࣅࢽࣝࠊ࢔࣑ࣝࢽ࣒࢘⟩
ὀពࠖࡢ㡯ཧ↷㸧
ෆ ⿦㸸ࢭࣟࢽ࣒࢘
እ ⟽㸸⣬
㸶㸬ྠ୍ᡂศ࣭ྠຠ⸆
࣒ࢥࢯࣝࣂࣥ㘄㸦ᖇேࣇ࢓࣮࣐㸧➼
㸷㸬ᅜ㝿ㄌ⏕ᖺ᭶᪥
୙᫂
㸯㸮㸬〇㐀㈍኎ᢎㄆᖺ᭶᪥ཬ
ࡧᢎㄆ␒ྕ
〇㐀㈍኎ᢎㄆᖺ᭶᪥㸸2008 ᖺ 3 ᭶ 6 ᪥
〇 㐀 ㈍ ኎ ᢎ ㄆ ␒ ྕ㸸22000AMZ00364000
㸯㸯㸬⸆౯ᇶ‽཰㍕ᖺ᭶᪥
2008 ᖺ 6 ᭶
㸯㸰㸬ຠ⬟ཪࡣຠᯝ㏣ຍࠊ⏝
ἲཬࡧ⏝㔞ኚ᭦࣭㏣ຍ
➼ࡢᖺ᭶᪥ཬࡧࡑࡢෆ
ᐜ
ヱᙜࡋ࡞࠸
㸯㸱㸬෌ᑂᰝ⤖ᯝࠊ෌ホ౯⤖
ᯝබ⾲ᖺ᭶᪥ཬࡧࡑࡢ
ෆᐜ
ヱᙜࡋ࡞࠸
㸯㸲㸬෌ᑂᰝᮇ㛫
ヱᙜࡋ࡞࠸
㸯㸳㸬ᢞ୚ᮇ㛫ᮇ㝈་⸆ရ࡟
㛵ࡍࡿ᝟ሗ
ᮏ๣ࡢ㐺ᛂᝈ⪅ࡢ࠺ࡕࠊࠕẼ⟶ᨭႍᜥࠖࠊࠕẼ⟶ᨭᣑᙇ⑕ࠖཬࡧࠕሻ⫵⑕ࠖ
ࡣࠊཌ⏕┬࿌♧➨ 73 ྕ㸦ᖹᡂ 12 ᖺ 3 ᭶ 17 ᪥㸧࡟ࡼࡾ 1 ᅇ 30 ᪥㛫ศᢞ
⸆ࡀㄆࡵࡽࢀ࡚࠸ࡿࠋ
㸯㸴㸬ྛ✀ࢥ࣮ࢻ
ཌ⏕┬⸆౯ᇶ‽཰㍕་⸆ရࢥ࣮ࢻ㸸2239001F1602
㸯㸵㸬ಖ㝤⤥௜ୖࡢὀព
ヱᙜࡋ࡞࠸
㹖㹇㸬ᩥ⊩
㸯㸬ᘬ⏝ᩥ⊩
1㸧ࢥࢺࣈ࣮ࣟࣝ㘄 15mg ࡜ᶆ‽〇๣࡜ࡢ⏕≀Ꮫⓗྠ➼ᛶヨ㦂㸦ᑑ〇⸆ᰴ
ᘧ఍♫♫ෆ㈨ᩱ㸧
2㸧ࢥࢺࣈ࣮ࣟࣝ㘄 15mg ࡢ⁐ฟᣲື㸦ᑑ〇⸆ᰴᘧ఍♫♫ෆ㈨ᩱ㸧
3㸧ࢥࢺࣈ࣮ࣟࣝ㘄 15mg ࡢᏳᐃᛶヨ㦂㸦ᑑ〇⸆ᰴᘧ఍♫♫ෆ㈨ᩱ㸧
㸰㸬ࡑࡢ௚ࡢཧ⪃ᩥ⊩
࡞ࡋ
㹖,,㸬ཧ⪃㈨ᩱ
㸯㸬୺࡞እᅜ࡛ࡢⓎ኎≧ἣ
Mucosolvan㸦すࢻ࢖ࢶࠊ࢖ࢱࣜ࢔ࠊࢫ࢖ࢫ㸧
Mucosan㸦ࢫ࣌࢖ࣥ㸧
㸰㸬ᾏእ࡟࠾ࡅࡿ⮫ᗋᨭ᥼᝟ሗ
࡞ࡋ
㹖,,,㸬ഛ⪃
ࡑࡢ௚ࡢ㛵㐃㈨ᩱ
࡞ࡋ
〇㐀㈍኎ඖ
ᑑ〇⸆ᰴᘧ఍♫