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平 2 6 薬 務 第 3 3 6 号 平成 26 年(2014 年)7 月 9 日
ᖹ ⸆ ົ ➨ ྕ ᖹ ᡂ ᖺ ᖺ ᭶ ᪥ ୍⯡♫ᅋἲேᒣཱྀ┴་ᖌ㛗 බ┈♫ᅋἲேᒣཱྀ┴ṑ⛉་ᖌ㛗 ୍⯡♫ᅋἲேᒣཱྀ┴⸆ᖌ㛗 ୍⯡♫ᅋἲேᒣཱྀ┴㝔༠㛗 ᒣ ཱྀ ┴ 㝔 ⸆ ᖌ 㛗 ᵝ ᒣ ཱྀ ┴ ⸆ ᴗ ༺ ༠ 㛗 ᒣཱྀ┴་⒪ᶵჾ㈍ᴗ༠㛗 ᒣཱྀ┴ᗣ⚟♴㒊⸆ົㄢ㛗 ࠕ་⸆ရ࣭་⒪ᶵჾ➼ࡢᅇࡘ࠸࡚ࠖࡢ୍㒊ᨵṇࡘ࠸࡚ ࡇࡢࡇࡘ࠸࡚ࠊཌ⏕ປാ┬་⸆ရ㣗ရᒁ㛗ࡽูῧࡋࡢ࠾ࡾ㏻▱ࡀ࠶ࡾࡲࡋࡓ ࡢ࡛ࠊ࠾▱ࡽࡏࡋࡲࡍࠋ ⸆ົㄢ〇⸆ᣦᑟ⌜ ᢸᙜ㸸ᯘ 7(/ )$; 㸱㸬ᅇ㏻▱ࡢู⣬㸰ࡋ࡚ࠊูῧ㸱ࢆຍ࠼ࡿࠋ 㸲㸬ᅇ㏻▱ࡢู⣬㸲ࡋ࡚ࠊูῧ㸲ࢆຍ࠼ࡿࠋ 㸯 ሗᥦ౪ಀࡿᇶᮏⓗ⪃࠼᪉ 㸦␎㸧 㸦㸯㸧ࢡࣛࢫศ㢮ࡘ࠸࡚ ᪧ 㸰 ࣥࢱ࣮ࢿࢵࢺࢆά⏝ࡋࡓሗᥦ౪ 㸦␎㸧 㸰 ࣥࢱ࣮ࢿࢵࢺࢆά⏝ࡋࡓሗᥦ౪ 㸦␎㸧 ࠋ࡞࠾ཧ⪃ࡲ࡛㈨ᩱࢆ㸦ู⣬㸯㸧♧ࡍࠋ࡞࠾ࠊ ᅇ╔ᡭࡋࡓ་⸆ရࡀࠊḢᕞඹྠయ࠾࠸࡚ࡶ㈍ ࠋ࡞࠾ࠊཧ⪃ࡲ࡛㈨ᩱࢆ㸦ู⣬㸯㸧♧ࡍࠋ ࡉࢀ࡚࠸ࡿᛮࢃࢀࡿࡶࡢ࡛࠶ࡗ࡚ࠊࠕ┦ᢎㄆ㛵 ㈨ᩱࡣ௨ୗࡢ㡯ࢆグ㍕ࡍࡿࡇࡋࠊ⡆₩ࡘ ࢃࡾࡸࡍ࠸ෆᐜ࡞ࡿࡼ࠺༑ศ࡞㓄៖ࢆồࡵࡿࡇ 㸬ᥦฟࡍࡁ㈨ᩱ ㈨ᩱࡣ௨ୗࡢ㡯ࢆグ㍕ࡍࡿࡇࡋࠊ⡆₩ࡘ ࢃࡾࡸࡍ࠸ෆᐜ࡞ࡿࡼ࠺༑ศ࡞㓄៖ࢆồࡵࡿࡇ 㸬ᥦฟࡍࡁ㈨ᩱ 㸦㸯㸧〇㐀㈍ᴗ⪅➼ࡼࡿࣥࢱ࣮ࢿࢵࢺᥖ㍕⏝㈨ᩱࡢస 㸦㸯㸧〇㐀㈍ᴗ⪅➼ࡼࡿࣥࢱ࣮ࢿࢵࢺᥖ㍕⏝㈨ᩱࡢస ᡂཬࡧᥦฟࡘ࠸࡚ ᡂཬࡧᥦฟࡘ࠸࡚ 㸦␎㸧 㸦␎㸧 㸦␎㸧 ࠸࠺ࠋ ࡣࡲࡎ⪃࠼ࡽࢀ࡞࠸≧ἣࢆ࠸࠺ࠋ 㸦␎㸧 ࡢཎᅉ࡞ࡿྍ⬟ᛶࡀ࠶ࡿཪࡣ㔜⠜࡞ ᗣ⿕ᐖࡢ࠾ࡑࢀࡣࡲࡎ⪃࠼ࡽࢀ࡞࠸≧ἣࢆ ࡢཎᅉ࡞ࡿྍ⬟ᛶࡀ࠶ࡿ≧ἣཪࡣࡑࡢ〇 ရࡢ⏝➼ࡼࡿ㔜⠜࡞ᗣ⿕ᐖࡢ࠾ࡑࢀ 㸦␎㸧 㸦␎㸧 ࢡࣛࢫϩ㸸ࢡࣛࢫϩࡣࠊࡑࡢ〇ရࡢ⏝➼ࡀࠊ୍ ࢡࣛࢫϩ㸸ࢡࣛࢫϩࡣࠊࡑࡢ〇ရࡢ⏝➼ࡀࠊ୍ ⓗ࡞ⱝࡋࡃࡣ་Ꮫⓗ⒵ྍ⬟࡞ᗣ⿕ᐖ ⓗ࡞ⱝࡋࡃࡣ་Ꮫⓗ⒵ྍ⬟࡞ᗣ⿕ᐖ 㸦␎㸧 㸦㸯㸧ࢡࣛࢫศ㢮ࡘ࠸࡚ 㸯 ሗᥦ౪ಀࡿᇶᮏⓗ⪃࠼᪉ ᪂ ู࠙ῧ㸯ࠚ ฟࢆồࡵࡿࡇࠋ ࢡࣛࢫϩ㸸ᅇᑐ㇟〇ရࢆᑐ㇟ᅜࡢ࠸ࡎࢀᑐࡋ࡚㍺ 㐀㈍ᴗ⪅➼ᑐࡋ࡚ࠊ⥭ᛴᅇ㏻ሗࡢཎ✏ᥦ ᅇࡢࢡࣛࢫศ㢮ᛂࡌ࡚ࠊ௨ୗࡢᑐᛂࡍࡿࠋ ࢡࣛࢫϨ㸸ᅇᑐ㇟〇ရࢆ㍺ฟࡋ࡚࠸ࡿ࠺㛵ࢃ ࡽࡎ⥭ᛴᅇ㏻ሗࡢⓎಙࡀᚲせ࡞ࡿࡓࡵࠊ〇 GMP ┬௧㐺ྜࡉࡏ࡞ࡅࢀࡤ࡞ࡽ࡞࠸ ࡉࢀ࡚࠸ࡿ་⸆ရ 㸦㸰㸧ᑐ㇟ရ┠ࡘ࠸࡚ᅇࡀⓎ⏕ࡋࡓሙྜࡢᑐᛂ ู⣬㸰♧ࡍࠋ᭱᪂ࡢᑐ㇟ᅜࡘ࠸࡚ࡣࠊ PIC/S ཬࡧḢᕞ㐃ྜࡢ࢙࢘ࣈࢧࢺ➼ࡼ ࡾࠊሗࢆධᡭࡍࡿࡇࠋ .ᑐ㇟ရ┠㸸〇㐀ᡤࡢ〇㐀⟶⌮ཬࡧရ㉁⟶⌮ࡢ᪉ἲࢆ 㸦PIC/S㸧ຍ┕ᅜཬࡧḢᕞ㐃ྜ ཧ⪃ࡋ࡚ࠊᖹᡂ 26 ᖺ㸵᭶⌧ᅾࡢᑐ㇟ᅜࢆ 㸱 ᾏእࡢᅇሗࡢⓎಙ 㸦᪂タ㸧 㸦㸯㸧ᑐ㇟ᅜཬࡧᑐ㇟ရ┠ .ᑐ㇟ᅜ㸸་⸆ရᰝᐹ༠ᐃ࣭་⸆ရᰝᐹ༠ྠࢫ࣮࣒࢟ ရಀࡿඃⰋ〇㐀ᡤᇶ‽㸦㹅㹋㹎㸧㛵ࡍࡿศ㔝ู ᒓ᭩ࠖࡼࡾ㐺⏝ࡉࢀࡿࡶࡢ࡛࠶ࡿሙྜࡣࠊู⣬㸰 ㈨ᩱࢆసᡂࡍࡿࡼ࠺ồࡵࡿࡇࠋ ࡍࡿ᪥ᮏᅜḢᕞඹྠయࡢ㛫ࡢ༠ᐃࠖࡀࡑࡢࠕ་⸆ ᑟ࣭㯞⸆ᑐ⟇ㄢᥦฟࡋࡓ᪥⥭ᛴᅇ㏻ሗࡢཎ✏ࡶ 㟁Ꮚ࣓࣮ࣝࡼࡾ⥭ᛴᅇ㏻ሗࡢཎ✏ࢆᥦฟࡍࡿࡇ ࠋཎ๎ࡋ࡚ࠊࣥࢱ࣮ࢿࢵࢺᥖ㍕⏝㈨ᩱࢆ┘どᣦ ࢆⱥㄒ࡛సᡂࡍࡿࡇࠋ .㒔㐨ᗓ┴ࡣࠊ〇㐀㈍ᴗ⪅➼ࡽ⥭ᛴᅇ㏻ሗࡢཎ✏ ᥦฟࢆཷࡅࡓᚋࠊ㏿ࡸ┘どᣦᑟ࣭㯞⸆ᑐ⟇ㄢࡲ࡛ 㸦㸱㸧⥭ᛴᅇ㏻ሗࡢཎ✏సᡂࡽ⥭ᛴᅇ㏻ሗⓎಙࡲ࡛ࡢ ᡭ㡰 .〇㐀㈍ᴗ⪅➼ࡣࠊู⣬㸱ࡼࡾ⥭ᛴᅇ㏻ሗࡢཎ✏ ⪅➼ᑐࡋ࡚⥭ᛴᅇ㏻ሗࡢཎ✏ᥦฟࢆồࡵ ࡿࡇࠋ ࢡࣛࢫϪ㸸⥭ᛴᅇ㏻ሗࡢⓎಙࡣࠊཎ๎ࡋ࡚せ࡛࠶ ࡿࠋ ㇟〇ရࢆ㍺ฟࡋ࡚࠸ࡿྍ⬟ᛶࡀ࠶ࡿሙྜࡣࠊ᪥ ᮏᅜෆ࡛ࡢᅇࢆỴᐃࡋࡓⅬ࡛ࠊ〇㐀㈍ᴗ ࡿࠋ㸧 ࡞࠾ࠊᅇᑐ㇟ࣟࢵࢺࡸ㍺ฟඛࡀ≉ᐃ࡛ࡁ࡚ ࠸࡞ࡃࡶࠊᑐ㇟ᅜࡢ࠸ࡎࢀᑐࡋ࡚ᅇᑐ ࡞ࡿࡓࡵࠊࡑࡢሙྜࡣ〇㐀㈍ᴗ⪅➼ᑐࡋ ࡚ࠊ⥭ᛴᅇ㏻ሗࡢཎ✏ᥦฟࢆồࡵࡿࡇࠋ 㸦ᅇ ᑐ㇟〇ရࢆᑐ㇟ᅜ㍺ฟࡋ࡚࠸࡞࠸ሙྜࡣࠊ ⥭ᛴᅇ㏻ሗࡢⓎಙࡣࠊཎ๎ࡋ࡚せ࡛࠶ ฟࡋ࡚࠸ࡿሙྜࡣ⥭ᛴᅇ㏻ሗࡢⓎಙࡀᚲせ 㸲 ሗ㐨ᶵ㛵ᑐࡍࡿ༠ຊࡢせㄳ 㸦␎㸧 ࢆồࡵࡿࡇࠋࣇ࢛࣮ࣟࢵࣉሗࡢཎ✏సᡂࡽⓎಙ ࡲ࡛ࡢᡭ㡰ࡣࠊୖグ㸦㸱㸧ྠᵝ࡛࠶ࡿࠋ ࡾࣇ࢛࣮ࣟࢵࣉሗࢆᑐ㇟ᅜⓎಙࡍࡿᚲせࡀ࠶ࡿࡢ ࡛ࠊ〇㐀㈍ᴗ⪅➼ᑐࡋ࡚ࣇ࢛࣮ࣟࢵࣉሗࡢᥦฟ ᪥ᮏᅜෆ࡛ࡢᅇࢆỴᐃࡋࡓⅬ࡛ࡣᅇᑐ㇟⠊ᅖ ࡀ≉ᐃ࡛ࡁ࡚࠸࡞ࡗࡓࡀࠊࡑࡢᚋࠊᅇᑐ㇟⠊ᅖ㸦ࣟ ࢵࢺࠊ㍺ฟඛᅜ➼㸧ࡀ≉ᐃ࡛ࡁࡓሙྜࡣࠊู⣬㸲ࡼ ࢘.┘どᣦᑟ࣭㯞⸆ᑐ⟇ㄢࡣࠊ㒔㐨ᗓ┴ࡽ⥭ᛴᅇ㏻ሗ ࡢཎ✏ᥦฟࢆཷࡅࡓᚋࠊ㏿ࡸ㟁Ꮚ࣓࣮ࣝࡼࡾᑐ ㇟ᅜ⥭ᛴᅇ㏻ሗࢆⓎಙࡍࡿࠋ 㸦㸲㸧ࣇ࢛࣮ࣟࢵࣉሗ ᥦฟࡍࡿࡇࠋ 㸱 ሗ㐨ᶵ㛵ᑐࡍࡿ༠ຊࡢせㄳ 㸦␎㸧 ู࠙ῧ㸰ࠚ 㸦ู⣬㸱㸧 MINISTRY OF HEALTH, LABOUR AND WELFARE GOVERNMENT OF JAPAN 2-2, KASUMIGASEKI 1-CHOME, CHIYODA-KU, TOKYO 100-8916 IMPORTANT - DELIVER IMMEDIATELY This is intended only for the use of the party to whom it is addressed and may contain information that is privileged, confidential and protected from disclosure under the Mutual Recognition Agreement and PIC/S and other applicable domestic laws and regulations. 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Thank you. ⥭ᛴᅇ㏻ሗ Rapid Alert Notification of a Quality Defect/Recall 1.㸨ᐄඛ To: 2.㸨ᅇࢡࣛࢫ Product Recall Class of D 3.㸨ഇ㐀ရྰ Counterfeit /Fraud: efect: ࠙ Yes ࣭ No ࠚ ࠙ I ࣭ II ࠚ(ヱᙜࢡࣛࢫࢆ࡛ۑᅖࡴ) 4.〇ရ Product: 5.ᢎㄆ␒ྕ Marketing Authorization Number: 6.㈍ྡ Brand/Trade Name: 7.୍⯡ྡ INN or Generic Name: 8.ᆺ Dosage Form: 9.ศ㔞 Strength: 10.ࣟࢵࢺ␒ྕ Batch/Lot Number: 11.᭷ຠᮇ㝈 Expiry Date: 12.ໟࢧࢬ➼ Pack size and Presentation: 13.〇㐀ᖺ᭶᪥ Date Manufactured: 14.ᢎㄆಖᣢ⪅ Marketing Authorization Holder: 15. 〇㐀ᴗ⪅ Manufacturer: 㐃⤡ඛ Contact Person: 16. ᅇᐇᴗ⪅ Recalling Firm (if different) 㸦〇㐀ᴗ⪅␗࡞ࡿሙྜグ㍕ࡍࡿࡇ㸧 㐃⤡ඛ Contact Person: 㟁ヰ Telephone: 㟁ヰ Telephone: 17.㸨ᅇ␒ྕ Recall Number Assigned: 18.ရ㉁Ḟ㝗ࡢヲ⣽㸭ᅇ⌮⏤ Details of Defects/Reason for Recall: 19.ὶ㏻ሗ Information on distribution including exports (type of customer, e.g. hospitals ): 20.㸨㏻ሗඖᙜᒁࡼࡿᥐ⨨ Action taken by Issuing Authority: 21.㸨ᥦࡉࢀࡿᥐ⨨ Proposed Action: 22.㏻ሗඖᙜᒁ From (Issuing Authority): 23.㐃⤡ඛ Contact Person: Compliance and Narcotics Division GMP Section Pharmaceutical and Food Safety Bureau FAX: +81-3-3501-0034 Ministry of Health, Labour and Welfare of Japan 24.㸨⨫ྡ Signed: 25.㸨ᖺ᭶᪥ Date: 26.㸨 Time: 㸦ὀព㸧 ࣭ ⏝⣬ࡢࡁࡉࡣࠊ᪥ᮏᕤᴗつ᱁ A4 ࡍࡿࡇ ࣭ ࠕ㸨ࠖࢆࡘࡅࡓ㡯┠ࡣࠊ✵ḍࡋ࡚࠾ࡃࡇࠋ ࣭ ࠕ4.〇ရ Productࠖḍࡣࠊ㈍ྡࡢ࠺ࡕ௦⾲ⓗ࡞ࡶࡢࢆグ㍕ࡍࡿࡶࠊ〇ရࡢ እᙧⓗ࡞≉ᚩ㸦㸸ࠕwhite tablets㸦ⓑ࠸㘄㸧ࠖ㸧ࢆ⡆༢グ㍕ࡍࡿࡇࠋ ࣭ ࠕ6.㈍ྡ Brand/Trade Nameࠖḍࡣࠊ㈍ྡࢆグ㍕ࡍࡿࡇࠋ᪥ᮏࡣูࡢ㈍ ྡ࡛㈍ࡋ࡚࠸ࡿᅜࡀ࠶ࡿሙྜࡣࠊᅜྡᙜヱᅜ࡛ࡢ㈍ྡࢆิᣲࡍࡿࡇࠋ ࣭ ࠕ7.୍⯡ྡ INN or Generic Nameࠖḍࡣࠊ᭷ຠᡂศࡢ୍⯡ྡࢆグ㍕ࡍࡿࡇࠋ」ᩘ ࡢ᭷ຠᡂศࢆྵ᭷ࡍࡿሙྜࡣࠊิᣲࡍࡿࡇࠋ ࣭ ࠕ19.ὶ㏻ሗ Information on distribution including exportsࠖḍࠊ㍺ฟඛࡢᅜྡࢆグ ධࡍࡿࡇࠋ ࣭ࠕ4.〇ရ Product:ࠖࠊ ࠕ6.㈍ྡ Brand/Trade Nameࠖࠊ ࠕ10.ࣟࢵࢺ␒ྕ Batch/Lot Numberࠖࠊ ࠕ11.᭷ຠᮇ㝈 Expiry Dateࠖࠊࠕ13.〇㐀ᖺ᭶᪥ Date Manufacturedࠖ➼ࡢ㛵㐃ࡍࡿ㡯┠ ࢆ୍ぴ⾲ࡋࠊู⣬ࡋ࡚♧ࡍࡇ࡛ࡶᕪࡋᨭ࠼࡞࠸ࠋࡑࡢሙྜࠊู⣬グ㍕ࡋࡓ㡯 ┠ࡢḍࡣࠕsee the attached fileࠖグ㍕ࡍࡿࡇࠋ ࣭ ᫂࡞ሙྜࡣࠊࠕN/Aࠖグ㍕ࡍࡿࡇࠋ ู࠙ῧ㸱ࠚ 㸦ู⣬㸰㸧 ⥭ᛴᅇ㏻ሗⓎಙࡢᑐ㇟࡞ࡿᅜ㸦ᖹᡂ ᖺ㸵᭶Ⅼ㸧 ࣋ࣝࢠ࣮ࠊࣈࣝ࢞ࣜࠊࢳ࢙ࢥࠊࢹ࣐࣮ࣥࢡࠊࢻࢶࠊ࢚ࢫࢺࢽࠊࣝࣛࣥࢻࠊࢠࣜ ࢩࣕࠊࢫ࣌ࣥࠊࣇࣛࣥࢫࠊࢡࣟࢳࠊࢱࣜࠊ࢟ࣉࣟࢫࠊࣛࢺࣅࠊࣜࢺࢽࠊ ࣝࢡࢭࣥࣈࣝࢡࠊࣁ࣮ࣥ࢞ࣜࠊ࣐ࣝࢱࠊ࢜ࣛࣥࢲࠊ࣮࢜ࢫࢺࣜࠊ࣏࣮ࣛࣥࢻࠊ࣏ࣝࢺ࢞ ࣝࠊ࣮࣐ࣝࢽࠊࢫࣟ࣋ࢽࠊࢫࣟࣂ࢟ࠊࣇࣥࣛࣥࢻࠊࢫ࢙࣮࢘ࢹࣥࠊࢠࣜࢫࠊ ࢫࣛࣥࢻࠊࢫ࢚ࣛࣝࠊࣜࣄࢸࣥࢩࣗࢱࣥࠊࣀ࢙࣮ࣝ࢘ࠊࢫࢫࠊ࢘ࢡࣛࢼࠊ࢝ࢼ ࢲࠊ࣓ࣜ࢝ྜ⾗ᅜࠊࣝࢮࣥࢳࣥࠊ࣐࣮ࣞࢩࠊࢩ࣏࣮ࣥ࢞ࣝࠊࣥࢻࢿࢩࠊྎ‴ࠊ 㡑ᅜࠊ࣮࢜ࢫࢺࣛࣜࠊࢽ࣮ࣗࢪ࣮ࣛࣥࢻࠊ༡ࣇࣜ࢝ 㸦ͤ㸧ୗ⥺㸸05$ ༠ᐃᇶ࡙ࡁࠊࠕ་⸆ရಀࡿඃⰋ〇㐀ᡤᇶ‽㸦*03㸧㛵ࡍ ࡿศ㔝ูᒓ᭩ࠖࡼࡾ㐺⏝ࡉࢀࡿ་⸆ရࡘ࠸࡚ࡣࠊᖹᡂ ᖺ㸵 ᭶௨๓ࡽࠊ⥭ᛴᅇ㏻ሗࢆⓎಙࡋ࡚࠸ࡓᅜ 3,&6 ຍ┕ᅜ㸦ᖹᡂ ᖺ㸵᭶Ⅼ㸧 ᆅᇦ 3,&6 ຍ┕ᅜ Ḣᕞ ࣮࢜ࢫࢺࣜࠊ࣋ࣝࢠ࣮ࠊ࢟ࣉࣟࢫࠊࢳ࢙ࢥࠊࢹ࣐࣮ࣥࢡࠊ࢚ࢫࢺࢽࠊ ࣇࣥࣛࣥࢻࠊࣇࣛࣥࢫࠊࢻࢶࠊࢠࣜࢩࣕࠊࣁ࣮ࣥ࢞ࣜࠊࢫࣛࣥࢻࠊ ࣝࣛࣥࢻࠊࢫ࢚ࣛࣝࠊࢱࣜࠊࣛࢺࣅࠊࣜࣄࢸࣥࢩࣗࢱࣥࠊ ࣜࢺࢽࠊ࣐ࣝࢱࠊ࢜ࣛࣥࢲࠊࣀ࢙࣮ࣝ࢘ࠊ࣏࣮ࣛࣥࢻࠊ࣏ࣝࢺ࢞ࣝࠊ ࣮࣐ࣝࢽࠊࢫࣟࣂ࢟ࠊࢫࣟ࣋ࢽࠊࢫ࣌ࣥࠊࢫ࢙࣮࢘ࢹࣥࠊࢫࢫࠊ ࢘ࢡࣛࢼࠊࢠࣜࢫ ⡿ ࢝ࢼࢲࠊ࣓ࣜ࢝ྜ⾗ᅜ ୰༡⡿ ࣝࢮࣥࢳࣥ ࢪ ࣐࣮ࣞࢩࠊࢩ࣏࣮ࣥ࢞ࣝࠊࣥࢻࢿࢩࠊྎ‴ࠊ㡑ᅜࠊ᪥ᮏ ࢜ࢭࢽ ࣮࢜ࢫࢺࣛࣜࠊࢽ࣮ࣗࢪ࣮ࣛࣥࢻ ࣇࣜ࢝ ༡ࣇࣜ࢝ 㸦ͤ㸧3,&6 ຍ┕ᅜࡣࠊ௨ୗࡢ࣮࣒࣮࣍࣌ࢪ࡛☜ㄆ࡛ࡁࡿࠋ KWWSSLFVFKHPHRUJPHPEHUVSKS Ḣᕞ㐃ྜ㸦ᖹᡂ ᖺ㸵᭶⌧ᅾ㸧 ࣋ࣝࢠ࣮ࠊࣈࣝ࢞ࣜࠊࢳ࢙ࢥࠊࢹ࣐࣮ࣥࢡࠊࢻࢶࠊ࢚ࢫࢺࢽࠊࣝࣛࣥࢻࠊࢠࣜ ࢩࣕࠊࢫ࣌ࣥࠊࣇࣛࣥࢫࠊࢡࣟࢳࠊࢱࣜࠊ࢟ࣉࣟࢫࠊࣛࢺࣅࠊࣜࢺࢽࠊ ࣝࢡࢭࣥࣈࣝࢡࠊࣁ࣮ࣥ࢞ࣜࠊ࣐ࣝࢱࠊ࢜ࣛࣥࢲࠊ࣮࢜ࢫࢺࣜࠊ࣏࣮ࣛࣥࢻࠊ࣏ࣝࢺ࢞ ࣝࠊ࣮࣐ࣝࢽࠊࢫࣟ࣋ࢽࠊࣇࣥࣛࣥࢻࠊࢫ࢙࣮࢘ࢹࣥࠊࢠࣜࢫ ู࠙ῧ㸲ࠚ 㸦ู⣬㸲㸧 MINISTRY OF HEALTH, LABOUR AND WELFARE GOVERNMENT OF JAPAN 2-2, KASUMIGASEKI 1-CHOME, CHIYODA-KU, TOKYO 100-8916 FOLLOW-UP AND NON-URGENT INFORMATION FOR QUALITY DEFECTS . 1.㸨ᐄඛ To: 2.㸨ᅇ␒ྕ Recall Number Assigned: 2a.㸨ᅜෆ࠾ࡅࡿᅇ␒ྕ National reference number (When applicable) 4.〇ရ Product: 5.ᢎㄆ␒ྕ Marketing Authorization number: 6.㈍ྡ Brand/Trade name: 7.୍⯡ྡ INN or Generic Name: 8.ᙧ Dosage form: 9.ศ㔞 Strength: 10.ࣟࢵࢺ␒ྕ Batch number (and bulk, if different) 14.ᢎㄆಖᣢ⪅ Marketing Authorization folder: 15.〇㐀ᴗ⪅ Manufacturer: 16.㐃⤡ඛ Contact Person: 17.ヲ⣽ Subject title: 22.㏻ሗඖᙜᒁ From (issuing Authority): 23.㐃⤡ඛ Contact Person: Compliance and Narcotics Division GMP Section Pharmaceutical and Food Safety Bureau FAX: +81-3-3501-0034 Ministry of Health, Labour and Welfare of Japan 24.㸨⨫ྡ Signed: 25.㸨ᖺ᭶᪥ Date: 26.㸨 Time: 㸦ὀព㸧 ࣭ ⏝⣬ࡢࡁࡉࡣࠊ᪥ᮏᕤᴗつ᱁ A4 ࡍࡿࡇ ࣭ ࠕ㸨ࠖࢆࡘࡅࡓ㡯┠ࡣࠊ✵ḍࡋ࡚࠾ࡃࡇࠋ ࣭ ࠕ17. ヲ⣽ Subject titleࠖḍࡣࠊ᪂ࡓุ᫂ࡋࡓᅇᑐ㇟⠊ᅖ㸦ࣟࢵࢺࠊ㍺ฟඛᅜ ➼㸧ࡢሗࢆグ㍕ࡍࡿࡇࠋ ་⸆ရ࣭་⒪ᶵჾ➼ࡢᅇࡘ࠸࡚ 㸦ᖹᡂ㸯㸰ᖺ㸱᭶㸶᪥ ་⸆Ⓨ➨㸰㸱㸵ྕ㸧 㸦ྛ㒔㐨ᗓ┴▱࠶࡚ཌ⏕┬་⸆Ᏻᒁ㛗㏻▱㸧 ᨵṇᖹᡂ㸯㸳ᖺ㸵᭶㸱㸮᪥ ⸆㣗Ⓨ➨ ྕ ᖹᡂ㸯㸴ᖺ㸳᭶㸰㸶᪥ ⸆㣗Ⓨ➨ ྕ ᖹᡂ㸯㸵ᖺ㸱᭶㸱㸯᪥ ⸆㣗Ⓨ➨ ྕ ᖹᡂ㸰㸱ᖺ㸱᭶㸰㸰᪥ ⸆ 㣗 Ⓨ ➨ 㸱 ྕ ᖹ ᡂ 㸰 㸴 ᖺ 㸵 ᭶ 㸯 ᪥ ⸆ 㣗 Ⓨ ➨ 㸰 ྕ ⸆ἲ㸦㸱㸳ᖺἲᚊ➨㸯㸲㸳ྕࠋ௨ୗࠕἲࠖ࠸࠺ࠋ㸧➨㸵㸵᮲ࡢ㸲ࡢ㸱ࡢつᐃ ᇶ࡙ࡁࠊ་⸆ရࠊ་⸆㒊እရࠊ⢝ရⱝࡋࡃࡣ་⒪ᶵჾ㸦௨ୗࠕ་⸆ရ࣭་⒪ᶵჾ➼ࠖ ࠸࠺ࠋ㸧ࡢ〇㐀㈍ᴗ⪅ⱝࡋࡃࡣእᅜ≉ᢎㄆྲྀᚓ⪅ཪࡣἲ➨㸶㸮᮲➨㸯㡯つᐃࡍࡿ㍺ ฟ⏝ࡢ་⸆ရ࣭་⒪ᶵჾ➼ࡢ〇㐀ᴗ⪅㸦௨ୗࠕ〇㐀㈍ᴗ⪅➼ࠖ࠸࠺ࠋ㸧ࡣࠊࡑࡢ〇㐀 ㈍ࢆࡋࠊ〇㐀ࢆࡋࠊཪࡣᢎㄆࢆཷࡅࡓ་⸆ရ࣭་⒪ᶵჾ➼ࡢᅇ╔ᡭࡋࡓࡁࠊࡑࡢ ᪨ࢆཌ⏕ປാ┬௧࡛ᐃࡵࡿࡇࢁࡼࡾཌ⏕ປാ⮧㸦ἲ➨㸶㸯᮲ࡢつᐃᇶ࡙ࡃ⸆ἲ ⾜௧㸱㸴ᖺᨻ௧➨㸯㸯ྕ㸧➨㸶㸮᮲➨㸯㡯➨㸲ྕࠊ➨㸰㡯➨㸰ྕཪࡣྠ㡯➨㸲ྕ ಀࡿሙྜ࠶ࡗ࡚ࡣ㒔㐨ᗓ┴▱㸧ሗ࿌ࡍࡿᚲせࡀ࠶ࡿࡀࠊᮏ᮶ᅇࡍࡿᚲせࡀ࠶ࡿ ⪃࠼ࡽࢀࡿ་⸆ရ࣭་⒪ᶵჾ➼ࡘ࠸࡚㐺ษᅇࡉࢀࡎᚲせ࡞ሗ࿌ࡀࡉࢀ࡞࠸ࡇࡸᚲ せ௨ୖࡢ⠊ᅖࡢ་⸆ရ࣭་⒪ᶵჾ➼ࡀᅇࡉࢀࡿࡇ➼ࡼࡿಖ⾨⏕ୖࡢၥ㢟ࡀ⏕ࡌ࡞ ࠸ࡼ࠺ࠊ⯡ࠕ་⸆ရ࣭་⒪ᶵჾ➼ࡢᅇ㛵ࡍࡿ┘どᣦᑟせ㡿ࠖࢆูῧ㸯ࡢ࠾ࡾࡾ ࡲࡵࡓࡢ࡛ࠊࡑࡢᐇᙜࡓࡗ࡚ࡣ㑇₃࡞ࡁࡼ࠺ࡍࡿࡶࠊ㈗⟶ୗ〇㐀㈍ᴗ⪅ ➼ᑐࡍࡿᣦᑟ᪉ࡼࢁࡋࡃᚚ㓄៖ࢆ࠾㢪࠸ࡋࡓ࠸ࠋ ࡲࡓࠊἲ➨㸵㸵᮲ࡢ㸱ࡢつᐃᇶ࡙ࡁࠊ་⸆ရ࣭་⒪ᶵჾ➼ࡢ〇㐀㈍ᴗ⪅➼ࡀࠊࡑࡢ 〇㐀㈍ࢆࡋࠊ〇㐀ࢆࡋࠊཪࡣᢎㄆࢆཷࡅࡓ་⸆ရ࣭་⒪ᶵჾ➼ࡢᅇ╔ᡭࡋࡓሙྜࠊ ಖ⾨⏕ୖࡢ⿕ᐖࡢⓎ⏕ཪࡣᣑࡢ㜵Ṇࡢࡓࡵࠊᙜヱ〇㐀㈍ᴗ⪅➼ࡣ㐺ษᅇሗ ࢆᥦ౪ࡍࡿᚲせࡀ࠶ࡾࠊ⯡ࠊࡼࡾ㐺ษ࡞ሗᥦ౪ࢆ⾜࠺ほⅬࡽࠊࠕ་⸆ရ࣭་⒪ᶵჾ ➼ࡢᅇሗࡢᥦ౪᪉ἲ㛵ࡍࡿせ㡿ࠖࢆูῧ㸰ࡢ࠾ࡾᐃࡵࡓࡢ࡛ࠊᚋࡣᙜヱせ㡿 ᚑࡗ࡚㈗⟶ୗࡢ〇㐀㈍ᴗ⪅➼ࡢᣦᑟ᪉ࠊࡼࢁࡋࡃᚚ㓄៖ࢆ࠾㢪࠸ࡋࡓ࠸ࠋ ࡉࡽࠊᮍᅇ〇ရࡼࡿᗣ⿕ᐖࡢⓎ⏕ࢆ㜵Ṇࡍࡿࡓࡵࠊ⸆ົ⟶ㄢ་ົ⟶ㄢࡢ ༠ຊࡢୗࠊ㈗⟶ୗᨻ௧ᕷࠊಖᡤタ⨨ᕷཬࡧ≉ู༊㐃ᦠࡢୖࠊ་⒪ᶵ㛵➼ࡢ㛵ಀ⪅ᑐ ࡋࠊ〇㐀㈍ᴗ⪅➼ࡽᙜヱ་⒪ᶵ㛵➼ᅇࡢ౫㢗ࡀ࠶ࡗࡓሙྜࡣࠊᅇ₃ࢀࡀ࡞࠸ࡼ ࠺་⒪ᶵ㛵➼ෆࡢ㛵ಀ⪅࡛ሗࡀඹ᭷ࡉࢀࠊಖ᭷ࡍࡿ〇ရࢆ㐺ษ☜ㄆࡍࡿ࡞ࠊᅇ ࡈ༠ຊ࠸ࡓࡔࡁࡓ࠸᪨ࢆ࿘▱ࡋࠊ〇㐀㈍ᴗ⪅➼ࡀ་⸆ရ࣭་⒪ᶵჾ➼ࡢᅇࢆ⾜࠺㝿 ࡢᑐᛂࡢᚭᗏ᪉ࠊࡼࢁࡋࡃᚚ㓄៖ࢆ࠾㢪࠸ࡋࡓ࠸ࠋ ࡞࠾ࠊูῧ㸯㸦㸰㸦㸰㸧ཬࡧ㸱㸦㸰㸧ࢆ㝖ࡃࠋ㸧ࡘ࠸࡚ࡣࠊἲ➨㸴㸷᮲➨㸯㡯ཬࡧ➨ 㸱㡯ࠊ➨㸵㸳᮲➨㸯㡯ཪࡣ➨㸵㸵᮲ࡢ㸲ࡢ㸱ࡢつᐃᇶ࡙ࡃົࢆฎ⌮ࡍࡿ㝿ࡢᆅ᪉⮬ ἲ㸦㸰㸰ᖺἲᚊ➨㸴㸵ྕ㸧➨㸰㸲㸳᮲ࡢ㸷つᐃࡍࡿฎ⌮ᇶ‽ࡍࡿࠋ ࡲࡓࠊࡇࡢ㏻▱ࡢⓎฟక࠸ᖹᡂ㸷ᖺ㸱᭶㸰㸵᪥⸆Ⓨ➨㸲㸰㸯ྕ⸆ົᒁ㛗㏻▱ࠊグࡢ➨ 㸳ࠊ㸲ཬࡧ㸳ࡘ࠸࡚ࡣᖹᡂ㸯㸰ᖺ㸲᭶㸯᪥๐㝖ࡍࡿࠋࡲࡓࡇࡢ㏻▱ࡢูῧ㸯ࡢ㸯ࡘ ࠸࡚ࡣࡇࡢ㏻▱Ⓨฟࡢ᪥ࡼࡾࠊࡑࡢࡘ࠸࡚ࡣᖹᡂ㸯㸰ᖺ㸲᭶㸯᪥ࡼࡾ⾜ࡋࠊᖹᡂ㸯 㸰ᖺ㸱᭶㸱㸯᪥௨๓╔ᡭࡋࡓ་⸆ရ࣭་⒪ᶵჾ➼ࡢᅇࡘ࠸࡚ࡣᚑ๓ࡢࡼࡿࡇ ࡍࡿࠋ ูῧ㸯 ་⸆ရ࣭་⒪ᶵჾ➼ࡢᅇ㛵ࡍࡿ┘どᣦᑟせ㡿 㸯 ᅇࡢᐃ⩏࣭ᇶᮏⓗ⪃࠼᪉ ἲ➨㸵㸵᮲ࡢ㸲ࡢ㸱ࡢつᐃᇶ࡙ࡃᅇሗ࿌ࡘ࠸࡚ࡣࠊ〇㐀㈍ᴗ⪅➼ࡀ⮬ⓗ ᅇ╔ᡭࡋࡓሙྜࠊࡑࡢᐇࢆሗ࿌ࡉࡏࡿࡇࡼࡾࠊⰋ་⸆ရ࣭་⒪ᶵჾ➼ 㛵ࡍࡿሗࢆ᪩ᮇᢕᥱࡋࠊࡇࡢࡼ࠺࡞་⸆ရ࣭་⒪ᶵჾ➼ࡼࡿಖ⾨⏕ୖࡢ༴ ᐖࡢⓎ⏕ཪࡣᣑࢆ㜵Ṇࡍࡿࡓࡵࡢไᗘ࡛࠶ࡿࠋ௬་⸆ရ࣭་⒪ᶵჾ➼ఱࡽࡢ Ⰻཪࡣලྜ㸦௨ୗࠕⰋࠖ࠸࠺ࠋ㸧ࡀ⏕ࡌࡓሙྜࠊⓎ⏕ࡍࡿ࠾ࡑࢀࡢ࠶ࡿᗣ ⿕ᐖࡢ⛬ᗘࠊⰋࡀ⏕ࡌ࡚࠸ࡿྍ⬟ᛶࡢ㧗࠸〇ရ⠊ᅖࡢ≉ᐃ➼ࡘ࠸࡚⛉Ꮫⓗぢᆅ ࡽ༑ศ᳨ウࡋࠊ〇㐀㈍ᴗ⪅➼ࡼࡾ☜ᐇᚲせ࡞ᅇࡀᐇࡉࢀࡿࡇࡀ㔜せ࡛࠶ ࡿࠋᅇࡢᐃ⩏ཬࡧᅇᙜࡓࡗ࡚ࡢᇶᮏⓗ࡞⪃࠼᪉ࡘ࠸࡚ࡣ௨ୗࡢ࠾ࡾ࡛࠶ࡿ ࡢ࡛ࠊ〇㐀㈍ᴗ⪅➼ᑐࡋࠊ㐺ษᅇࢆ⾜࠺ࡇཬࡧࡑࡢሗ࿌㑇₃࡞ࡁࡼ࠺ᣦ ᑟࡍࡿࡇࠋ ࡞࠾ࠊᅇಀࡿಶูලయⓗ࡞⩏ࡀ⏕ࡌࡓሙྜࡣ㒔㐨ᗓ┴⸆ົ⟶ㄢࡼࡾཌ⏕ ປാ┬་⸆㣗ရᒁ┘どᣦᑟ࣭㯞⸆ᑐ⟇ㄢ↷ࡍࡿࡇࠋ 㸦㸯㸧ᅇࡢᐃ⩏ 㸬ࠕᅇࠖࡣࠊ〇㐀㈍ᴗ⪅➼ࡀࡑࡢ〇㐀㈍ࢆࡋࠊ〇㐀ࢆࡋࠊཪࡣᢎㄆࢆཷ ࡅࡓ་⸆ရ࣭་⒪ᶵჾ➼ࢆᘬࡁྲྀࡿࡇࠊཪࡣࠕᨵಟࠖࡍࡿࡇࢆ࠸࠺ࠋࡓࡔ ࡋࠕᅾᗜฎ⌮ࠖཬࡧࠕ⌧ရࠖࢆ㝖ࡃࠋࡲࡓ〇㐀㈍ᴗ⪅➼ࡀ᪂〇ရࡢ㈍ ᙜࡓࡾရ㉁ࠊ᭷ຠᛶཬࡧᏳᛶၥ㢟ࡢ࡞࠸ᪧ〇ရࢆ⨨ࡁ࠼ࡿ⾜Ⅽࢆ㝖 ࡃࠋ 㸬ࠕᨵಟࠖࡣࠊ〇㐀㈍ᴗ⪅➼ࡀࡑࡢ〇㐀㈍ࢆࡋࠊ〇㐀ࢆࡋࠊཪࡣᢎㄆࢆཷ ࡅࡓ་⒪ᶵჾࢆ≀⌮ⓗࡢሙᡤ⛣ືࡍࡿࡇ࡞ࡃࠊಟ⌮ࠊᨵⰋࠊㄪᩚࠊᗫ Რཪࡣ┘ど㸦ᝈ⪅ࡢࣔࢽࢱࣜࣥࢢࢆྵࡴ㸧ࢆ⾜࠺ࡇࢆ࠸࠺ࠋ ࢘㸬ࠕᅾᗜฎ⌮ࠖࡣࠊ〇㐀㈍ᴗ⪅➼ࡀࡑࡢ〇㐀㈍ࢆࡋࠊ〇㐀ࢆࡋࠊཪࡣᢎㄆ ࢆཷࡅࡓ་⸆ရ࣭་⒪ᶵჾ➼࡛࠶ࡗ࡚ᮍࡔ㈍ࡋ࡚࠸࡞࠸ࡶࡢࠊཪࡣᮍࡔ〇㐀 ㈍ᴗ⪅➼ࡢ┤᥋ࡢ⟶⌮ࡽ㞳ࢀ࡚࠸࡞࠸ࡶࡢࡘ࠸࡚ࠊ〇㐀㈍ᴗ⪅➼ࡀࡇ ࢀࢆᘬࡁྲྀࡾࠊཪࡣಟ⌮ࠊᨵⰋࠊㄪᩚⱝࡋࡃࡣᗫᲠࡍࡿࡇࢆ࠸࠺ࠋࡓࡔࡋࠊ ㈤㈚➼ࠊ〇㐀㈍ᴗ⪅➼ࡀᡤ᭷ᶒࢆ᭷ࡋ࡞ࡀࡽ〇㐀㈍ᴗ⪅➼௨እࡢ⪅ࡀࡑࡢ ་⒪ᶵჾࢆ⌧⏝ࡋ࡚࠸ࡿࡶࡢཪࡣ⏝ࡍࡿ┠ⓗ࡛〇㐀㈍ᴗ⪅➼௨እࡢ ሙᡤ࡛㈓ⶶࡋ࡚࠸ࡿࡶࡢᑐࡍࡿࡇࢀࡽࡢ⾜Ⅽࢆ㝖ࡃࠋ ࢚㸬ࠕ⌧ရࠖࡣࠊಖ⾨⏕ୖࡢၥ㢟ࡀ⏕ࡌ࡞࠸ࡇࡀ᫂ࡽ࡞ሙྜ࡛࠶ࡗ࡚ࠊ ࡘࣟࢵࢺཪࡣ࠶ࡿ୍ᐃ⠊ᅖࡢ་⸆ရ࣭་⒪ᶵჾ➼ࠊᙜヱ〇ရ௨እࡢ་⸆ရ࣭ ་⒪ᶵჾ➼ྠᵝ࡞⍗⑅ࡀ⏕ࡌ࡞࠸ࡇࡀ᫂ࡽ࡞ࡁࠊᴗ⪅ࡀᙜヱ་⸆ရ ࣭་⒪ᶵჾ➼ࢆᘬࡁྲྀࡾࡍࡿࡇ㸦་⒪ᶵჾ࠶ࡗ࡚ࡣࠊಟ⌮ࠊᨵⰋࠊㄪ ᩚࠊᗫᲠཪࡣ┘どࢆ⾜࠺ࡇ㸧ࢆ࠸࠺ࠋ 㸦㸰㸧ᅇᙜࡓࡗ࡚ࡢᇶᮏⓗ⪃࠼᪉ 㸬᭷ຠᛶཬࡧᏳᛶࡢほⅬࡽࡢุ᩿ 㸦㺏㸧ఱࡽࡢⰋࡼࡾ་⸆ရ࣭་⒪ᶵჾ➼ࡢᏳᛶၥ㢟ࡀ࠶ࡿሙྜࡣᅇࡍ ࡿࡇࠋ Ᏻᛶၥ㢟ࡀ࡞࠸ሙྜ࡛࠶ࡗ࡚ࡶ᭷ຠᛶࡢၥ㢟➼ࡼࡾᮇᚅࡉࢀࡿຠᯝ ࡀᚓࡽࢀ࡞࠸ሙྜࡣᅇࡍࡿࡇࠋࡲࡓࠊ〇㐀㈍ᴗ⪅➼ࡀࡑࡢ〇㐀㈍ࢆ ࡋࠊ〇㐀ࢆࡋࠊཪࡣᢎㄆࢆཷࡅࡓ་⸆ရ࣭་⒪ᶵჾ➼ࡢⰋ㛵ࡋ࡚᭷ຠᛶཬ ࡧᏳᛶၥ㢟ࡀ࡞࠸᫂☜ㄝ࡛᫂ࡁ࡞࠸ሙྜࡣᙜヱ་⸆ရ࣭་⒪ᶵჾ➼ ࢆᅇࡍࡿࡇࠋ 㸦㺐㸧⸆ἲཪࡣᢎㄆ㡯㐪ࡍࡿ་⸆ရ࣭་⒪ᶵჾ➼ࡣᅇࡍࡿࡇࠋ 㸬Ⰻ⠊ᅖࡢ≉ᐃ㛵ࡍࡿุ᩿ 㸦㺏㸧་⸆ရ࣭་⒪ᶵჾ➼ఱࡽࡢⰋࡀ⏕ࡌࡓሙྜࠊᙜヱ〇㐀㈍ᴗ⪅➼ࡀࡑ ࡢⰋࡘ࠸࡚ࣟࢵࢺཪࡣ〇ရయཬࡪࡶࡢ࡛ࡣ࡞࠸᫂☜ㄝ࡛᫂ࡁ࡞ ࠸ሙྜࡣᅇࡍࡿࡇࠋලయⓗࡣ௨ୗࡢࡍ࡚ࡢ᮲௳ࢆ‶ࡓࡋ࡚࠸ࡿሙྜ ௨እࡘ࠸࡚ࡣࠊࣟࢵࢺཪࡣ〇ရయⰋࡀཬࡤ࡞࠸࠸࠼࡞࠸ࡶࡢࡋ࡚ ᅇࡍࡿࡇࠋ ձ ⰋရⓎ⏕ࡢཎᅉᕤ⛬ࡀ≉ᐃ࡛ࡁࡿࡇࠋ ղ ⰋⓎ⏕㜵Ṇࡢࡓࡵࡢᥐ⨨ࡀ㐺ษㅮࡌࡽࢀ࡚࠾ࡾࠊ㹅㹋㹎ୖࡢၥ㢟ࡀ ㄆࡵࡽࢀ࡞࠸ࡇࠋ ճ ಖᏑရࡢရ㉁␗ᖖࡀ࡞࠸ࡇࠋ մ ရ㉁ᙳ㡪ࢆཬࡰࡍ㹅㹏㹎ୖࡢၥ㢟ࡀㄆࡵࡽࢀ࡞࠸ࡇࠋ 㸦㺐㸧ᙜึࡣࣟࢵࢺཪࡣ〇ရయⰋࡀཬࡤ࡞࠸⪃࠼ࡽࢀࡓሙྜ࡛࠶ࡗ࡚ࡶࠊ ᐇ㝿」ᩘタ࠾࠸࡚ᙜヱⰋࡀ⏕ࡌࡓሙྜࡣࠊᙜヱⰋࡢⓎ⏕⋡ࡢ㛵 ಀࢆ⪃៖ࡋࡓୖ࡛ཎ๎ⓗᅇࡍࡿࡇࠋ 㸦㺑㸧ᆺ་⒪ᶵჾࠊᇙࡵ㎸ࡳᆺࡢ་⒪ᶵჾ➼ࠊࣟࢵࢺࢆᵓᡂࡋ࡞࠸་⒪ᶵჾࡢ Ⰻࡘ࠸࡚ࠊྠ✀〇ရྠᵝ࡞Ⰻࡀ࠶ࡿሙྜࠊᙜヱ〇ရ⩌ࢆࣟࢵࢺࡳ࡞ ࡋᅇ‽ࡌࡓᢅ࠸ࢆ⾜࠺ࡇࠋྠᵝⰋࡀྠ✀〇ရཬࡤ࡞࠸᫂☜ ㄝ࡛᫂ࡁࡿሙྜࡣࠊࠕ⌧ရࠖ‽ࡌࡓᢅ࠸ࡍࡿࡇࠋ ࢘㸬ΰධࡋࡓ␗≀ࡢ✀㢮〇ရࡢᛶ㉁ࡽࡢุ᩿ 㸦㺏㸧་⸆ရࡢሙྜࠊ〇ࡢ✀㢮㸦↓⳦〇࣭㠀↓⳦〇㸧ཬࡧΰධࡋࡓ␗≀ࡢ✀ 㢮㸦࢞ࣛࢫ∦➼ࡢෆᅾᛶ␗≀ࠊᮌ∦࡞ࡢእ᮶ᛶ␗≀ࠊẟ㧥࣭➼ࡢ⏕య⏤᮶ ≀㸧ࢆ຺ࡋุ࡚᩿ࡍࡿࡇࠋ↓⳦〇ࡘ࠸࡚ࡣཎ๎ⓗ↓⳦ᛶಖドࡀ☜ᐇ ྰࢆ㔜せ࡞ุ᩿ᇶ‽ࡋࠊእ᮶ᛶ␗≀ཬࡧ⏕య⏤᮶≀ࡀΰධࡋࡓሙྜࡣ ᅇࡍࡿࡇࠋ㠀↓⳦ᛶ〇ࡘ࠸࡚ࡣࠊ⏕య⏤᮶≀ࡀΰධࡋࡓሙྜࡣᅇ ࡍࡿࡇࠋ 㸦㺐㸧་⒪ᶵჾࡢ࠺ࡕࠊࢹࢫ࣏࣮ࢧࣈࣝ〇ရࡘ࠸࡚ࡣୖグ㺏ࢆ‽⏝ࡍࡿࡇࠋ 㸰 ᅇ╔ᡭሗ࿌ࡢྲྀᢅ࠸ࡘ࠸࡚ 㸦㸯㸧ᅇ╔ᡭሗ࿌ࡘ࠸࡚ ἲ➨㸵㸵᮲ࡢ㸲ࡢ㸱ᇶ࡙ࡃᅇ╔ᡭሗ࿌ࡘ࠸࡚ࡣࠊ⸆ἲ⾜つ๎㸦 㸱 㸴ᖺཌ⏕┬௧➨㸯ྕࠋ௨ୗࠕ┬௧ࠖ࠸࠺ࠋ㸧➨㸰㸳㸲᮲࠾࠸࡚ࡑࡢሗ࿌ࡍࡁ 㡯ࢆᐃࡵ࡚࠸ࡿࡀࠊཎ๎ⓗᙜヱሗ࿌ࡣᩥ᭩ࡼࡿࡶࡢࡍࡿࡇࠋࡓࡔࡋࠊಖ ⾨⏕ୖࡢ⿕ᐖⓎ⏕ཪࡣᣑࡢ㜵Ṇࡢࡓࡵ༴ᛴࡢࡀ࠶ࡿሙྜࡣࡑࡢᴫせࢆ ࣇࢵࢡࢫ➼ࡼࡾሗ࿌ࡢᚋࠊᚋ᪥ᩥ᭩ࢆᥦฟࡍࡿࡇ࡛ᕪࡋᨭ࠼࡞࠸ࠋ ࡞࠾ࠊᙜヱሗ࿌ࡢ㝿ࡣ┬௧➨㸰㸳㸲᮲ࡢつᐃᇶ࡙ࡁࠊ௨ୗࡢ㡯␃ពࡍࡿ ࡼ࠺ሗ࿌⪅ࢆᣦᑟࡍࡿࡇࠋ 㸬➨㸯ྕつᐃࡍࡿࠕᅇࢆ⾜࠺⪅ࡢẶྡཬࡧఫᡤࠖࡘ࠸࡚ࡣࠊἲே࠶ࡗ ࡚ࡣࡑࡢྡ⛠ࠊ௦⾲⪅ࡢẶྡཬࡧ⥲ᣓ〇㐀㈍㈐௵⪅ࡀࡑࡢᴗົࢆ⾜࠺ົ ᡤࡢᡤᅾᆅ୪ࡧᢸᙜ⪅Ặྡཬࡧࡑࡢ㐃⤡ඛࡘ࠸࡚᫂ࡽࡍࡿࡇࠋ 㸬➨㸰ྕつᐃࡍࡿࠕᅇࡢᑐ㇟࡞ࡿ་⸆ရࠊ་⸆㒊እရࠊ⢝ရཪࡣ་⒪ ᶵჾࡢྡ⛠ࠖࡘ࠸࡚ࡣࠊ୍⯡ⓗྡ⛠ཬࡧ㈍ྡࢆ᫂ࡽࡍࡿࡇࠋ ࢘㸬➨㸵ྕつᐃࡍࡿࠕᅇࡢ᪉ἲࠖࡘ࠸࡚ࡣࠊᅇᑐ㇟་⸆ရ࣭་⒪ᶵჾ➼ ࡢࣟࢵࢺ␒ྕࠊᩘ㔞ࠊฟⲴᮇࠊᅇᑐ㇟་⒪ᶵ㛵࣭ᝈ⪅➼㸦௨ୗࠕ་⒪ᶵ 㛵➼ࠖ࠸࠺ࠋ㸧ࡢ⠊ᅖࠊᙜヱᅇሗࡢ࿘▱᪉ἲࠊᅇ⤊ணᐃ᪥ཬࡧᅇ ඛ࠾࠸࡚ヱᙜရࢆཷ㡿ࡋࡓࡇࢆᩥ᭩ࡼࡾ☜ㄆࡍࡿ᪨ࢆྵࡴࡇࠋ ࢚㸬➨㸶ྕつᐃࡍࡿࠕࡑࡢಖ⾨⏕ୖࡢ⿕ᐖࡢⓎ⏕ཪࡣᣑࡢ㜵Ṇࡢࡓࡵ ㅮࡌࡼ࠺ࡍࡿᥐ⨨ࡢෆᐜࠖࡘ࠸࡚ࡣࠊᅇࡢ⌮⏤ཬࡧணࡉࢀࡿᗣ⿕ ᐖࡢ⛬ᗘࢆྵࡴࡇࠋ 㸦㸰㸧ᅇ╔ᡭሗ࿌ಀࡿ㒔㐨ᗓ┴ࡽཌ⏕ປാ┬ࡢ㐃⤡ 〇㐀㈍ᴗ⪅➼ࡽᅇ╔ᡭሗ࿌ࡀ࠶ࡗࡓሙྜࠊሗ࿌ࢆཷࡅࡓ㒔㐨ᗓ┴ࡣ㏿ࡸ ཌ⏕ປാ┬་⸆㣗ရᒁ┘どᣦᑟ࣭㯞⸆ᑐ⟇ㄢ࠶࡚ࡑࡢ᪨㐃⤡ࡍࡿࡼ࠺ᚚ༠ຊࢆ࠾ 㢪࠸ࡍࡿࠋࡑࡢ㝿ࠊ〇㐀㈍ᴗ⪅➼ࡼࡿᅇ╔ᡭሗ࿌ಀࡿᩥ᭩ࡢࡋࢆ㏦ࡍ ࡿࡼ࠺ᚚ༠ຊࢆ࠾㢪࠸ࡍࡿࠋࡓࡔࡋࠊಖ⾨⏕ୖࡢ⿕ᐖⓎ⏕ཪࡣᣑࡢ㜵Ṇࡢࡓࡵ ༴ᛴࡢࡀ࠶ࡾ㏿ࡸᩥ᭩ࢆ㏦ࡍࡿࡇࡀᅔ㞴࡞ሙྜࡣཱྀ㢌ሗ࿌ࡢᚋࠊ ᚋ᪥ᩥ᭩ࡢࡋࢆ㏦ࡍࡿࡇ࡛ᕪࡋᨭ࠼࡞࠸ࠋ 㸦㸱㸧ᅇ╔ᡭሗ࿌ᇶ࡙ࡃ〇㐀㈍ᴗ⪅➼ࡢᣦ♧➼ 㸬〇㐀㈍ᴗ⪅➼ࡽᅇ╔ᡭሗ࿌ࡀ࠶ࡗࡓሙྜࠊᚲせᛂࡌࠊሗ࿌ࢆཷࡅࡓ㒔㐨 ᗓ┴ࡣᙜヱ〇㐀㈍ᴗ⪅➼ᑐࡋࠊ௨ୗࡢ㡯➼ࠊᅇࡢ᪉ἲࡘࡁᣦ♧ࡍࡿࡇࠋ ࡞࠾ࠊᅇࡢᣦ♧ಀࡿྲྀᢅ࠸ࡢヲ⣽ࡘ࠸࡚ࡣࠊࠕ་⸆ရ➼ᗣ༴ᶵ⟶⌮ᐇ せ㡿ࠖࢆཧ⪃ࡍࡿࡇࠋ 㸦㺏㸧ᅇ⤊ணᐃ᪥ 㸦㺐㸧ᅇࡢ⠊ᅖ 㸦㺑㸧ᅇሗࡢ࿘▱᪉ἲ 㸦㺒㸧ᅇࡢ㐍ᤖ≧ἣࡘࡁᐃᮇⓗሗ࿌ࢆồࡵࡿ᪨ 㸦㺓㸧ࡑࡢᚲせ࡞㡯 㸬ୖグ㸦㺑㸧ࡘ࠸࡚ࡣࠊ௨ୗࡢ㡯ࡘࡁᣦ♧ࡍࡿࡇࠋ 㸦㺏㸧⣡ධඛࡢ་⒪ᶵ㛵➼௨እࡶᅇࡢᑐ㇟࡞ࡿ་⸆ရ࣭་⒪ᶵჾ➼ࡢᏑᅾࡀ⪃ ࠼ࡽࢀࡿሙྜࡣࠊ⣡ධඛ௨እᑐࡋ࡚ࡶࠊᗈࡃሗࡢ࿘▱ཬࡧᅇࢆ⾜࠺ࡇࠋ 㸦㺐㸧≉ࢡࣛࢫϨࡢᅇࡢሙྜࡣࠕ་⸆ရᏳ⟶⌮㈐௵⪅ࠖ㺂ࠕ་⒪ᶵჾᏳ⟶⌮ ㈐௵⪅ࠖཪࡣࠕႠᴗᡤ⟶⌮⪅ࠖ➼ሗࡢ࿘▱ࡀ⾜ࢃࢀ࡚࠸ࡿࡇࢆ☜ㄆࡋࡓୖ ࡛ࠊᩥ᭩ࡼࡾᅇရࡢ᭷↓ࡢ☜ㄆࢆ⾜࠺ࡇࠋ 㸱 ᅇ⤊ሗ࿌ࡘ࠸࡚ 㸦㸯㸧ᅇ⤊ಀࡿ〇㐀㈍ᴗ⪅➼ࡽ㒔㐨ᗓ┴ࡢሗ࿌ 〇㐀㈍ᴗ⪅➼ࡽᅇ╔ᡭሗ࿌ࡀ࠶ࡗࡓሙྜࠊሗ࿌ࢆཷࡅࡓ㒔㐨ᗓ┴ࡣ๓グ㸰 㸦㸱㸧ࡢᣦ♧ࡢࠊᙜヱ〇㐀㈍ᴗ⪅➼ᑐࡋᙜヱᅇࡀ⤊ࡋࡓ㝿ࠊ㏿ࡸ ࡑࡢ᪨ࢆᩥ᭩ࡼࡾሗ࿌ࡍࡿࡼ࠺ồࡵࡿࡇࠋࡲࡓࠊ᪤ㅮࡌࡓཪࡣᚋㅮࡌࡿᨵ ၿ⟇ࡢෆᐜཬࡧᅇࡋࡓ་⸆ရ࣭་⒪ᶵჾ➼ࡢฎศ᪉ἲࡘ࠸࡚࠶ࢃࡏ࡚ሗ࿌ࢆồ ࡵࡿࡇࠋ 㸦㸰㸧ᅇ⤊ಀࡿ㒔㐨ᗓ┴ࡽཌ⏕ປാ┬ࡢ㐃⤡ 〇㐀㈍ᴗ⪅➼ࡽᅇ⤊ಀࡿሗ࿌ࡀ࠶ࡗࡓሙྜࠊሗ࿌ࢆཷࡅࡓ㒔㐨ᗓ┴ࡣ ㏿ࡸཌ⏕ປാ┬་⸆㣗ရᒁ┘どᣦᑟ࣭㯞⸆ᑐ⟇ㄢ࠶࡚ࡑࡢ᪨㐃⤡ࡍࡿࡼ࠺ᚚ༠ ຊࢆ࠾㢪࠸ࡍࡿࠋࡑࡢ㝿ࠊ〇㐀㈍ᴗ⪅➼ࡼࡾᥦฟࡢ࠶ࡗࡓᅇ⤊ಀࡿሗ࿌ᩥ ᭩ࡢࡋࢆ㏦ࡍࡿࡼ࠺ᚚ༠ຊࢆ࠾㢪࠸ࡍࡿࠋ 㸲 ᅇ⤊ᚋᮍᅇ〇ရࡀⓎぢࡉࢀࡓሙྜࡢᥐ⨨ࡘ࠸࡚ ᅇࡢᚭᗏࡀࡉࢀ࡚࠸࡞࠸ࡇࡼࡾᮍᅇ〇ရࡀ་⒪ᶵ㛵➼Ꮡᅾࡋ࡚࠸ࡿࡇ ࡀุ᫂ࡋࡓሙྜࡣࠊᮍᅇ〇ရࡢ⏝➼ࡀᗣ⿕ᐖࡢཎᅉ࡞ࡿྍ⬟ᛶࡀ࠶ࡿࡇ ࡽࠊ་⒪ᶵ㛵➼ࡢ㛵ಀ⪅ཬࡧ୍⯡⏝⪅ᑐࡍࡿ㎿㏿࡞ὀពႏ㉳୪ࡧᅇࡢᚭᗏࢆ ᅗࡿࡼ࠺ᣦ♧ࡍࡿࡇࠋ 㸳 ࡑࡢ 㸦㸯㸧ᚲせᛂࡌࠊ〇㐀㈍ᴗ⪅➼ࡀ⾜࠺ᨵၿ⟇ࡢᐇ≧ἣཬࡧᅇࡋࡓ་⸆ရ࣭་⒪ ᶵჾ➼ࡢฎศ≧ἣࡘ࠸࡚☜ㄆࢆ⾜࠺ࡇࠋ 㸦㸰㸧๓グࡢࠊἲ➨㸴㸷᮲ᇶ࡙ࡃ〇㐀㈍ᴗ⪅➼ཪࡣ〇㐀ᴗ⪅➼ᑐࡍࡿ❧ධࡾ ᙜࡓࡗ࡚ࡣࠊࠕ་⸆ရࠊ་⸆㒊እရࠊ⢝ရཬࡧ་⒪ᶵჾࡢရ㉁⟶⌮ࡢᇶ‽㛵 ࡍࡿ┬௧ࠖ㸦ᖹᡂ㸯㸴ᖺཌ⏕ປാ┬௧➨㸯㸱㸴ྕ㸧ࠊࠕ་⸆ရཬࡧ་⸆㒊እရࡢ〇 㐀⟶⌮ཬࡧရ㉁⟶⌮ࡢᇶ‽㛵ࡍࡿ┬௧ࠖ㸦ᖹᡂ㸯㸴ᖺཌ⏕ປാ┬௧➨㸯㸵㸷ྕ㸧 ཪࡣࠕ་⒪ᶵჾཬࡧయእデ᩿⏝་⸆ရࡢ〇㐀⟶⌮ཬࡧရ㉁⟶⌮ࡢᇶ‽㛵ࡍࡿ┬ ௧ࠖ㸦ᖹᡂ㸯㸴ᖺཌ⏕ປാ┬௧➨㸯㸴㸷ྕ㸧ᇶ࡙ࡁᅇࡀ㐺ษ⾜ࢃࢀ࡚࠸ࡿ ࡘ࠸࡚ࡶ☜ㄆࢆ⾜࠺ࡇࠋ 㸦ูῧ㸰㸧 ་⸆ရ࣭་⒪ᶵჾ➼ࡢᅇሗࡢᥦ౪᪉ἲ㛵ࡍࡿせ㡿 㸯 ሗᥦ౪ಀࡿᇶᮏⓗ⪃࠼᪉ ᅇሗࡘ࠸࡚ࡣᚑ᮶࠾ࡾࡍ࡚ࡇࢀࢆබ㛤ࡍࡿࡇࡍࡿࠋᅇሗࡢᥦ౪ ᙜࡓࡗ࡚ࡣಶู〇㐀㈍ᴗ⪅➼ẖ་⒪ᶵ㛵➼ᑐࡋ࡚㏿ࡸࡑࡢሗࢆᥦ౪ࡍࡿ ࠊ〇㐀㈍ᴗ⪅➼ࡀ⾜࠺ሗᥦ౪ࢆ✚ᴟⓗᨭࡍࡿࡶࠊ་⒪ᶵ㛵➼ࡼࡿ ሗ㞟ࢆᐜ᫆ࡍࡿࡓࡵࠊಶูᅇẖᗣ⿕ᐖࡢⓎ⏕ཪࡣࡑࡢ࠾ࡑࢀࡢ⛬ᗘᛂ ࡌࡓ㐺ษ࡞ᡭẁࢆㅮࡌࡿࡇࡍࡿࠋ 㸦㸯㸧ࢡࣛࢫศ㢮ࡘ࠸࡚ ᅇᙜࡓࡗ࡚ࡣࠊᅇࡉࢀࡿ〇ရࡼࡾࡶࡓࡽࡉࢀࡿᗣࡢ༴㝤ᛶࡢ⛬ᗘ ࡼࡾࠊ௨ୗࡢ࠾ࡾಶูᅇࡈϨࠊϩཪࡣϪࡢᩘᏐࢆࡾᙜ࡚ࡿࡇ㸦௨ ୗࠕࢡࣛࢫศ㢮ࠖ࠸࠺ࠋ㸧ࡍࡿࠋ ࢡࣛࢫϨ㸸ࢡࣛࢫϨࡣࠊࡑࡢ〇ရࡢ⏝➼ࡀࠊ㔜⠜࡞ᗣ⿕ᐖཪࡣṚஸࡢཎ ᅉ࡞ࡾᚓࡿ≧ἣࢆ࠸࠺ࠋ ࢡࣛࢫϩ㸸ࢡࣛࢫϩࡣࠊࡑࡢ〇ရࡢ⏝➼ࡀࠊ୍ⓗ࡞ⱝࡋࡃࡣ་Ꮫⓗ ⒵ྍ⬟࡞ᗣ⿕ᐖࡢཎᅉ࡞ࡿྍ⬟ᛶࡀ࠶ࡿ≧ἣཪࡣࡑࡢ〇ရࡢ ⏝➼ࡼࡿ㔜⠜࡞ᗣ⿕ᐖࡢ࠾ࡑࢀࡣࡲࡎ⪃࠼ࡽࢀ࡞࠸≧ἣࢆ ࠸࠺ࠋ ࢡࣛࢫϪ㸸ࢡࣛࢫϪࡣࠊࡑࡢ〇ရࡢ⏝➼ࡀࠊᗣ⿕ᐖࡢཎᅉ࡞ࡿࡣࡲ ࡎ⪃࠼ࡽࢀ࡞࠸≧ἣࢆ࠸࠺ࠋ 㸦㸰㸧ࢡࣛࢫศ㢮ᙜࡓࡗ࡚ࡢᇶᮏⓗ⪃࠼᪉ 㸬ࢡࣛࢫศ㢮ࢆ⾜࠺ሙྜࠊᙜヱⰋ་⸆ရ࣭་⒪ᶵჾ➼ࡢ⏝㉳ᅉࡍࡿ┤᥋ⓗ ࡞Ᏻᛶಀࡿ≧ἣ㸦ᡭ⾡㛫ࡢᘏ㛗ࢆ⏕ࡌࡿ࠾ࡑࢀࡢ࠶ࡿ≧ἣ➼ࢆྵࡴࠋ㸧 ࡔࡅ࡛࡞ࡃࠊࡑࡢ⏝ࡼࡾᮇᚅࡉࢀࡿຠᯝࡀᚓࡽࢀ࡞࠸➼᭷ຠᛶಀࡿ≧ἣ 㸦ṇ☜࡞デ᩿ࡢᙳ㡪ࢆཬࡰࡍ࠾ࡑࢀࡢ࠶ࡿ≧ἣ➼ࢆྵࡴࠋ㸧ࡘ࠸࡚ࡶ຺ ࡋࠊࡇࢀࡽࢆ⥲ྜⓗ࡞ࠕᗣ⿕ᐖࠖࡋ࡚ࢡࣛࢫศ㢮ࢆ⾜࠺ࡇࠋ 㸬ᅇᙜࡓࡗ࡚ࡣᇶᮏⓗࢡࣛࢫϩヱᙜࡍࡿࡶࡢ⪃࠼ࠊᗣ⿕ᐖⓎ⏕ࡢཎ ᅉ࡞ࡿࡣࡲࡎ⪃࠼ࡽࢀ࡞࠸ࡍࡿ✚ᴟⓗ࡞⌮⏤ࡀ࠶ࢀࡤࢡࣛࢫϪࠊࢡࣛ ࢫϩࡼࡾࡶ᭦㔜⠜࡞ᗣ⿕ᐖⓎ⏕ࡢ࠾ࡑࢀࡀ࠶ࡿሙྜࡣࢡࣛࢫϨุ᩿ ࡍࡿࡇࠋ ࢘㸬ࢡࣛࢫϨⱝࡋࡃࡣࢡࣛࢫϪุ᩿ࡍࡿࡇࡀጇᙜᛮࢃࢀࡿሙྜࠊཪࡣࡑࡢᚋ ࡢ≧ἣࡼࡾᙜึࡢࢡࣛࢫศ㢮ࢆኚ᭦ࡍࡿࡇࡀጇᙜᛮࢃࢀࡿሙྜࡣࠊࡑ ࡢ⌮⏤ࢆ᫂☜ࡋࡓୖ࡛㒔㐨ᗓ┴⸆ົ⟶ㄢࡼࡾ๓ཌ⏕ປാ┬་⸆㣗ရ ᒁ┘どᣦᑟ࣭㯞⸆ᑐ⟇ㄢ┦ㄯࡍࡿࡇࠋ 㸰 ࣥࢱ࣮ࢿࢵࢺࢆά⏝ࡋࡓሗᥦ౪ 〇㐀㈍ᴗ⪅➼ࡣಶู་⒪ᶵ㛵➼ᑐࡍࡿ㎿㏿࡞ᅇሗࡢᥦ౪ࢆ⾜࠺ࠊ㎿㏿ ࡘᗈ⠊࡞ሗᥦ౪ࡢࡓࡵࠊࡍ࡚ࡢᅇሗࢆࣥࢱ࣮ࢿࢵࢺୖ㸦་⸆ရ་⒪ᶵჾ ሗᥦ౪࣮࣒࣮࣍࣌ࢪ㸧ᥖ㍕ࡍࡿࡇࠋ 㸦㸯㸧〇㐀㈍ᴗ⪅➼ࡼࡿࣥࢱ࣮ࢿࢵࢺᥖ㍕⏝㈨ᩱࡢసᡂཬࡧᥦฟࡘ࠸࡚ ་⸆ရ࣭་⒪ᶵჾ➼ࡢ〇㐀㈍ᴗ⪅➼ࡀࠊࡑࡢ〇㐀㈍ࢆࡋࠊ〇㐀ࢆࡋࠊཪࡣᢎ ㄆࢆཷࡅࡓ་⸆ရ࣭་⒪ᶵჾ➼ࡢᅇ╔ᡭࡋࡓሙྜࠊἲ➨㸵㸵᮲ࡢ㸲ࡢ㸱ࡢつᐃ ᇶ࡙ࡃᅇሗ࿌࠶ࢃࡏ࡚ࠊ㏿ࡸࣥࢱ࣮ࢿࢵࢺᥖ㍕⏝㈨ᩱ௨ୗࠕ㈨ᩱࠖ ࠸࠺ࠋࢆᥦฟࡍࡿࡼ࠺ồࡵࡿࡇࠋ 㸬ᥦฟࡍࡁ㈨ᩱ ㈨ᩱࡣ௨ୗࡢ㡯ࢆグ㍕ࡍࡿࡇࡋࠊ⡆₩ࡘࢃࡾࡸࡍ࠸ෆᐜ࡞ࡿ ࡼ࠺༑ศ࡞㓄៖ࢆồࡵࡿࡇࠋ࡞࠾ࠊཧ⪃ࡲ࡛㈨ᩱࢆ㸦ู⣬㸯㸧♧ࡍࠋ 㸦㺏㸧㈨ᩱసᡂᖺ᭶᪥ 㸦㺐㸧་⸆ရࠊ་⸆㒊እရࠊ⢝ရཪࡣ་⒪ᶵჾࡢู 㸦㺑㸧ࢡࣛࢫศ㢮ࡢู 㸦㺒㸧୍⯡ྡཬࡧ㈍ྡ 㸦㺓㸧ᑐ㇟ࣟࢵࢺࠊᩘ㔞ཬࡧฟⲴᮇ 㸦㺔㸧〇㐀㈍ᴗ⪅➼ྡ⛠ 㸦㺕㸧ᅇ⌮⏤ 㸦㺖㸧༴ࡉࢀࡿලయⓗ࡞ᗣ⿕ᐖ 㸦㺗㸧ᅇ㛤ጞᖺ᭶᪥ 㸦㺘㸧ຠ⬟࣭ຠᯝཪࡣ⏝㏵➼ 㸦㺙㸧ࡑࡢ 㸦㺚㸧ᢸᙜ⪅ཬࡧ㐃⤡ඛ 㸬ࡑࡢ 㸦㺏㸧㈨ᩱࡣཎ๎୍ရ┠ࡘࡁ୍㈨ᩱࡍࡿࡇࠋ 㸦㺐㸧 〇㐀㈍ᴗ⪅➼ᑐࡋࠊ㈨ᩱࡣࢸ࢟ࢫࢺᙧᘧ࡛సᡂࡍࡿࡼ࠺ồࡵࡿࡇࠋ 㸦㺑㸧㈨ᩱࡢ㒔㐨ᗓ┴ࡢᥦฟᙜࡓࡗ࡚ࡣࠊ㟁Ꮚ࣓࣮ࣝཪࡣࣇࣟࢵࣆ࣮ࢹ ࢫࢡ➼ࠊ㐺ษ࡞ᡭẁࡼࡿࡼ࠺ồࡵࡿࡇࠋ 㸦㸰㸧㒔㐨ᗓ┴ࡼࡾཌ⏕ປാ┬ࡢ㈨ᩱࡢ㌿㏦ࡘ࠸࡚ 〇㐀㈍ᴗ⪅➼ࡼࡾᥦฟࡢ࠶ࡗࡓ㈨ᩱࡘ࠸࡚ࡣ㏿ࡸཌ⏕ປാ┬་⸆㣗ရ ᒁ┘どᣦᑟ࣭㯞⸆ᑐ⟇ㄢ㌿㏦ࡍࡿࡇࠋ㌿㏦ᙜࡓࡗ࡚ࡣ㟁Ꮚ࣓࣮ࣝࡼࡿࡇ ࡀᮃࡲࡋ࠸ࠋ 㸱 ᾏእࡢᅇሗࡢⓎಙ 㸦㸯㸧ᑐ㇟ᅜཬࡧᑐ㇟ရ┠ ᑐ㇟ᅜ㸸་⸆ရᰝᐹ༠ᐃ࣭་⸆ရᰝᐹ༠ྠࢫ࣮࣒࢟㸦3,&6㸧ຍ┕ᅜཬࡧḢᕞ㐃ྜ ཧ⪃ࡋ࡚ࠊᖹᡂ ᖺ㸵᭶⌧ᅾࡢᑐ㇟ᅜࢆู⣬㸰♧ࡍࠋ᭱᪂ࡢᑐ㇟ᅜ ࡘ࠸࡚ࡣࠊ3,&6 ཬࡧḢᕞ㐃ྜࡢ࢙࢘ࣈࢧࢺ➼ࡼࡾࠊሗࢆධᡭࡍ ࡿࡇࠋ ᑐ㇟ရ┠㸸〇㐀ᡤࡢ〇㐀⟶⌮ཬࡧရ㉁⟶⌮ࡢ᪉ἲࢆ *03 ┬௧㐺ྜࡉࡏ࡞ࡅࢀࡤ࡞ ࡽ࡞࠸ࡉࢀ࡚࠸ࡿ་⸆ရ 㸦㸰㸧ᑐ㇟ရ┠ࡘ࠸࡚ᅇࡀⓎ⏕ࡋࡓሙྜࡢᑐᛂ ᅇࡢࢡࣛࢫศ㢮ᛂࡌ࡚ࠊ௨ୗࡢᑐᛂࡍࡿࠋ ࢡࣛࢫϨ㸸ᅇᑐ㇟〇ရࢆ㍺ฟࡋ࡚࠸ࡿ࠺㛵ࢃࡽࡎ⥭ᛴᅇ㏻ሗࡢⓎಙࡀᚲ せ࡞ࡿࡓࡵࠊ〇㐀㈍ᴗ⪅➼ᑐࡋ࡚ࠊ⥭ᛴᅇ㏻ሗࡢཎ✏ᥦฟࢆồࡵࡿ ࡇࠋ ࢡࣛࢫϩ㸸ᅇᑐ㇟〇ရࢆᑐ㇟ᅜࡢ࠸ࡎࢀᑐࡋ࡚㍺ฟࡋ࡚࠸ࡿሙྜࡣ⥭ᛴᅇ㏻ ሗࡢⓎಙࡀᚲせ࡞ࡿࡓࡵࠊࡑࡢሙྜࡣ〇㐀㈍ᴗ⪅➼ᑐࡋ࡚ࠊ⥭ᛴᅇ ㏻ሗࡢཎ✏ᥦฟࢆồࡵࡿࡇࠋ㸦ᅇᑐ㇟〇ရࢆᑐ㇟ᅜ㍺ฟࡋ࡚࠸࡞࠸ሙ ྜࡣࠊ⥭ᛴᅇ㏻ሗࡢⓎಙࡣࠊཎ๎ࡋ࡚せ࡛࠶ࡿࠋ㸧 ࡞࠾ࠊᅇᑐ㇟ࣟࢵࢺࡸ㍺ฟඛࡀ≉ᐃ࡛ࡁ࡚࠸࡞ࡃࡶࠊᑐ㇟ᅜࡢ࠸ࡎࢀ ᑐࡋ࡚ᅇᑐ㇟〇ရࢆ㍺ฟࡋ࡚࠸ࡿྍ⬟ᛶࡀ࠶ࡿሙྜࡣࠊ᪥ᮏᅜෆ࡛ࡢ ᅇࢆỴᐃࡋࡓⅬ࡛ࠊ〇㐀㈍ᴗ⪅➼ᑐࡋ࡚⥭ᛴᅇ㏻ሗࡢཎ✏ᥦฟࢆ ồࡵࡿࡇࠋ ࢡࣛࢫϪ㸸⥭ᛴᅇ㏻ሗࡢⓎಙࡣࠊཎ๎ࡋ࡚せ࡛࠶ࡿࠋ 㸦㸱㸧⥭ᛴᅇ㏻ሗࡢཎ✏సᡂࡽ⥭ᛴᅇ㏻ሗⓎಙࡲ࡛ࡢᡭ㡰 〇㐀㈍ᴗ⪅➼ࡣࠊู⣬㸱ࡼࡾ⥭ᛴᅇ㏻ሗࡢཎ✏ࢆⱥㄒ࡛సᡂࡍࡿࡇࠋ 㒔㐨ᗓ┴ࡣࠊ〇㐀㈍ᴗ⪅➼ࡽ⥭ᛴᅇ㏻ሗࡢཎ✏ࡢᥦฟࢆཷࡅࡓᚋࠊ㏿ࡸ ┘どᣦᑟ࣭㯞⸆ᑐ⟇ㄢࡲ࡛㟁Ꮚ࣓࣮ࣝࡼࡾ⥭ᛴᅇ㏻ሗࡢཎ✏ࢆᥦฟࡍࡿࡇࠋ ཎ๎ࡋ࡚ࠊࣥࢱ࣮ࢿࢵࢺᥖ㍕⏝㈨ᩱࢆ┘どᣦᑟ࣭㯞⸆ᑐ⟇ㄢᥦฟࡋࡓ᪥⥭ ᛴᅇ㏻ሗࡢཎ✏ࡶᥦฟࡍࡿࡇࠋ ࢘┘どᣦᑟ࣭㯞⸆ᑐ⟇ㄢࡣࠊ㒔㐨ᗓ┴ࡽ⥭ᛴᅇ㏻ሗࡢཎ✏ᥦฟࢆཷࡅࡓᚋࠊ㏿ࡸ 㟁Ꮚ࣓࣮ࣝࡼࡾᑐ㇟ᅜ⥭ᛴᅇ㏻ሗࢆⓎಙࡍࡿࠋ 㸦㸲㸧ࣇ࢛࣮ࣟࢵࣉሗ ᪥ᮏᅜෆ࡛ࡢᅇࢆỴᐃࡋࡓⅬ࡛ࡣᅇᑐ㇟⠊ᅖࡀ≉ᐃ࡛ࡁ࡚࠸࡞ࡗࡓࡀࠊࡑࡢ ᚋࠊᅇᑐ㇟⠊ᅖ㸦ࣟࢵࢺࠊ㍺ฟඛᅜ➼㸧ࡀ≉ᐃ࡛ࡁࡓሙྜࡣࠊู⣬㸲ࡼࡾࣇ࢛ࣟ ࣮ࢵࣉሗࢆᑐ㇟ᅜⓎಙࡍࡿᚲせࡀ࠶ࡿࡢ࡛ࠊ〇㐀㈍ᴗ⪅➼ᑐࡋ࡚ࣇ࢛࣮ࣟ ࢵࣉሗࡢᥦฟࢆồࡵࡿࡇࠋࣇ࢛࣮ࣟࢵࣉሗࡢཎ✏సᡂࡽⓎಙࡲ࡛ࡢᡭ㡰ࡣࠊ ୖグ㸦㸱㸧ྠᵝ࡛࠶ࡿࠋ 㸲 ሗ㐨ᶵ㛵ᑐࡍࡿ༠ຊࡢせㄳ 㸦㸯㸧ሗ㐨ᶵ㛵ྥࡅࡢᗈሗࡘ࠸࡚ ࣥࢱ࣮ࢿࢵࢺࢆ⏝ࡋ࡚ሗࢆධᡭࡋ࡚࠸ࡿ⪅௨እࡢ⪅ᑐࡋ࡚ࡶಖ⾨⏕ ୖࡢほⅬࡽᅇሗࢆ㎿㏿ࡘᗈ⠊ᥦ౪ࡍࡿᚲせࡀ࠶ࡿሙྜࡣࠊሗ㐨ᶵ㛵ࡢ ༠ຊࢆᚓࡿࡓࡵ〇㐀㈍ᴗ⪅➼ᑐࡋ࡚ሗ㐨ᶵ㛵ྥࡅࡢᗈሗ㸦௨ୗࠕࣉࣞࢫࣜࣜ ࣮ࢫࠖ࠸࠺ࠋ㸧ࢆ⾜࠺ࡼ࠺ồࡵࡿࡇࠋ ලయⓗࡣ௨ୗࡢሙྜࣉࣞࢫ࣮ࣜࣜࢫࡀᚲせ⪃࠼ࡽࢀࡿࡀࠊᚲせᛂࡌࡑࡢ ࡢሙྜ࠾࠸࡚ࣉࣞࢫ࣮ࣜࣜࢫࢆ⾜࠺ࡇࡣᕪࡋᨭ࠼࡞࠸ࠋ 㸬ࢡࣛࢫϨヱᙜࡍࡿᅇ㸦ࡓࡔࡋࠊࣟࢵࢺࢆᵓᡂࡋ࡞࠸་⸆ရ࣭་⒪ᶵჾ➼ ࡛࠶ࡗ࡚ྠ✀〇ရⰋࡀཬࡤࡎࠊࡘࠊᙜヱ་⸆ရ࣭་⒪ᶵჾ➼ࡀ⏝ ࡉࢀ࡞࠸ࡇࡀ☜ᐇ࡞ሙྜࢆ㝖ࡃࠋ㸧 㸬ࢡࣛࢫϩヱᙜࡍࡿᅇ㸦ࡓࡔࡋࠊ〇㐀㈍ᴗ⪅➼ࡀ᪤ᑐ㇟࡞ࡿ་⒪ᶵ 㛵➼ࢆ࡚ᢕᥱࡋ࡚࠸ࡿሙྜ➼ࠊሗ㐨ᶵ㛵ࢆ⏝ࡋࡓሗᥦ౪ࡢᚲせᛶஈ ࡋ࠸ሙྜࢆ㝖ࡃࠋ㸧 㸦㸰㸧ࣉࣞࢫ࣮ࣜࣜࢫ⏝㈨ᩱࡘ࠸࡚ 〇㐀㈍ᴗ⪅➼ࡼࡿࣉࣞࢫ࣮ࣜࣜࢫ⏝㈨ᩱࡢసᡂᙜࡓࡗ࡚ࡣࠊ๓グ㸰㸦㸯㸧 㸬♧ࡍྛ㡯ࡘ࠸࡚グ㍕ࡋࠊࡑࡢሙྜࠊᑓ㛛⏝ㄒࢆᴟຊ㑊ࡅࠊᅗ⾲ࢆ⏝࠸ࡿ ➼ࡢ㓄៖ࢆồࡵࡿࡇࠋ 㸦ู⣬㸯㸧 㸦㈨ᩱసᡂᖺ᭶᪥㸧 㸦་⸆ရ࣭་⸆㒊እရ࣭⢝ရ࣭་⒪ᶵჾࡢู㸧ᅇࡢᴫせ 㸦ࢡࣛࢫϨ࣭ࢡࣛࢫϩ࣭ࢡࣛࢫϪࡢู㸧 㸯㸬୍⯡ྡཬࡧ㈍ྡ 㸰㸬ᑐ㇟ࣟࢵࢺࠊᩘ㔞ཬࡧฟⲴᮇ 㸱㸬〇㐀㈍ᴗ⪅➼ྡ⛠ 㸲㸬ᅇ⌮⏤ 㸳㸬༴ࡉࢀࡿලయⓗ࡞ᗣ⿕ᐖ 㸴㸬ᅇ㛤ጞᖺ᭶᪥ 㸵㸬ຠ⬟࣭ຠᯝཪࡣ⏝㏵➼ 㸶㸬ࡑࡢ 㸷㸬ᢸᙜ⪅ཬࡧ㐃⤡ඛ 㸦ู⣬㸰㸧 ⥭ᛴᅇ㏻ሗⓎಙࡢᑐ㇟࡞ࡿᅜ㸦ᖹᡂ ᖺ㸵᭶Ⅼ㸧 ࣋ࣝࢠ࣮ࠊࣈࣝ࢞ࣜࠊࢳ࢙ࢥࠊࢹ࣐࣮ࣥࢡࠊࢻࢶࠊ࢚ࢫࢺࢽࠊࣝࣛࣥࢻࠊࢠࣜ ࢩࣕࠊࢫ࣌ࣥࠊࣇࣛࣥࢫࠊࢡࣟࢳࠊࢱࣜࠊ࢟ࣉࣟࢫࠊࣛࢺࣅࠊࣜࢺࢽࠊ ࣝࢡࢭࣥࣈࣝࢡࠊࣁ࣮ࣥ࢞ࣜࠊ࣐ࣝࢱࠊ࢜ࣛࣥࢲࠊ࣮࢜ࢫࢺࣜࠊ࣏࣮ࣛࣥࢻࠊ࣏ࣝࢺ࢞ ࣝࠊ࣮࣐ࣝࢽࠊࢫࣟ࣋ࢽࠊࢫࣟࣂ࢟ࠊࣇࣥࣛࣥࢻࠊࢫ࢙࣮࢘ࢹࣥࠊࢠࣜࢫࠊ ࢫࣛࣥࢻࠊࢫ࢚ࣛࣝࠊࣜࣄࢸࣥࢩࣗࢱࣥࠊࣀ࢙࣮ࣝ࢘ࠊࢫࢫࠊ࢘ࢡࣛࢼࠊ࢝ࢼ ࢲࠊ࣓ࣜ࢝ྜ⾗ᅜࠊࣝࢮࣥࢳࣥࠊ࣐࣮ࣞࢩࠊࢩ࣏࣮ࣥ࢞ࣝࠊࣥࢻࢿࢩࠊྎ‴ࠊ 㡑ᅜࠊ࣮࢜ࢫࢺࣛࣜࠊࢽ࣮ࣗࢪ࣮ࣛࣥࢻࠊ༡ࣇࣜ࢝ 㸦ͤ㸧ୗ⥺㸸05$ ༠ᐃᇶ࡙ࡁࠊࠕ་⸆ရಀࡿඃⰋ〇㐀ᡤᇶ‽㸦*03㸧㛵ࡍࡿศ㔝ู ᒓ᭩ࠖࡼࡾ㐺⏝ࡉࢀࡿ་⸆ရࡘ࠸࡚ࡣࠊᖹᡂ ᖺ㸵᭶௨๓ࡽࠊ⥭ᛴᅇ ㏻ሗࢆⓎಙࡋ࡚࠸ࡓᅜ 3,&6 ຍ┕ᅜ㸦ᖹᡂ ᖺ㸵᭶Ⅼ㸧 ᆅᇦ 3,&6 ຍ┕ᅜ Ḣᕞ ࣮࢜ࢫࢺࣜࠊ࣋ࣝࢠ࣮ࠊ࢟ࣉࣟࢫࠊࢳ࢙ࢥࠊࢹ࣐࣮ࣥࢡࠊ࢚ࢫࢺࢽࠊ ࣇࣥࣛࣥࢻࠊࣇࣛࣥࢫࠊࢻࢶࠊࢠࣜࢩࣕࠊࣁ࣮ࣥ࢞ࣜࠊࢫࣛࣥࢻࠊ ࣝࣛࣥࢻࠊࢫ࢚ࣛࣝࠊࢱࣜࠊࣛࢺࣅࠊࣜࣄࢸࣥࢩࣗࢱࣥࠊ ࣜࢺࢽࠊ࣐ࣝࢱࠊ࢜ࣛࣥࢲࠊࣀ࢙࣮ࣝ࢘ࠊ࣏࣮ࣛࣥࢻࠊ࣏ࣝࢺ࢞ࣝࠊ ࣮࣐ࣝࢽࠊࢫࣟࣂ࢟ࠊࢫࣟ࣋ࢽࠊࢫ࣌ࣥࠊࢫ࢙࣮࢘ࢹࣥࠊࢫࢫࠊ ࢘ࢡࣛࢼࠊࢠࣜࢫ ⡿ ࢝ࢼࢲࠊ࣓ࣜ࢝ྜ⾗ᅜ ୰༡⡿ ࣝࢮࣥࢳࣥ ࢪ ࣐࣮ࣞࢩࠊࢩ࣏࣮ࣥ࢞ࣝࠊࣥࢻࢿࢩࠊྎ‴ࠊ㡑ᅜࠊ᪥ᮏ ࢜ࢭࢽ ࣮࢜ࢫࢺࣛࣜࠊࢽ࣮ࣗࢪ࣮ࣛࣥࢻ ࣇࣜ࢝ ༡ࣇࣜ࢝ 㸦ͤ㸧3,&6 ຍ┕ᅜࡣࠊ௨ୗࡢ࣮࣒࣮࣍࣌ࢪ࡛☜ㄆ࡛ࡁࡿࠋ KWWSSLFVFKHPHRUJPHPEHUVSKS Ḣᕞ㐃ྜ㸦ᖹᡂ ᖺ㸵᭶⌧ᅾ㸧 ࣋ࣝࢠ࣮ࠊࣈࣝ࢞ࣜࠊࢳ࢙ࢥࠊࢹ࣐࣮ࣥࢡࠊࢻࢶࠊ࢚ࢫࢺࢽࠊࣝࣛࣥࢻࠊࢠࣜ ࢩࣕࠊࢫ࣌ࣥࠊࣇࣛࣥࢫࠊࢡࣟࢳࠊࢱࣜࠊ࢟ࣉࣟࢫࠊࣛࢺࣅࠊࣜࢺࢽࠊ ࣝࢡࢭࣥࣈࣝࢡࠊࣁ࣮ࣥ࢞ࣜࠊ࣐ࣝࢱࠊ࢜ࣛࣥࢲࠊ࣮࢜ࢫࢺࣜࠊ࣏࣮ࣛࣥࢻࠊ࣏ࣝࢺ࢞ ࣝࠊ࣮࣐ࣝࢽࠊࢫࣟ࣋ࢽࠊࣇࣥࣛࣥࢻࠊࢫ࢙࣮࢘ࢹࣥࠊࢠࣜࢫ 㸦ู⣬㸱㸧 MINISTRY OF HEALTH, LABOUR AND WELFARE GOVERNMENT OF JAPAN 2-2, KASUMIGASEKI 1-CHOME, CHIYODA-KU, TOKYO 100-8916 IMPORTANT - DELIVER IMMEDIATELY This is intended only for the use of the party to whom it is addressed and may contain information that is privileged, confidential and protected from 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Thank you. ⥭ᛴᅇ㏻ሗ Rapid Alert Notification of a Quality Defect/Recall 1.㸨ᐄඛ To: 2.㸨ᅇࢡࣛࢫ Product Recall Class of 3.㸨ഇ㐀ရྰ Counterfeit /Fraud: Defect: ࠙ Yes ࣭ No ࠚ ࠙ I ࣭ II ࠚ(ヱᙜࢡࣛࢫࢆ࡛ۑᅖࡴ) 4.〇ရ Product: 5.ᢎㄆ␒ྕ Marketing Authorization Number: 6.㈍ྡ Brand/Trade Name: 7.୍⯡ྡ INN or Generic Name: 8.ᆺ Dosage Form: 9.ศ㔞 Strength: 10.ࣟࢵࢺ␒ྕ Batch/Lot Number: 11.᭷ຠᮇ㝈 Expiry Date: 12.ໟࢧࢬ➼ Pack size and Presentation: 13.〇㐀ᖺ᭶᪥ Date Manufactured: 14.ᢎㄆಖᣢ⪅ Marketing Authorization Holder: 15. 〇㐀ᴗ⪅ Manufacturer: 㐃⤡ඛ Contact Person: 㟁ヰ Telephone: 16. ᅇᐇᴗ⪅ Recalling Firm (if different) 㸦〇㐀ᴗ⪅␗࡞ࡿሙྜグ㍕ࡍࡿࡇ㸧 㐃⤡ඛ Contact Person: 㟁ヰ Telephone: 17.㸨ᅇ␒ྕ Recall Number Assigned: 18.ရ㉁Ḟ㝗ࡢヲ⣽㸭ᅇ⌮⏤ Details of Defects/Reason for Recall: 19.ὶ㏻ሗ Information on distribution including exports (type of customer, e.g. hospitals ): 20.㸨㏻ሗඖᙜᒁࡼࡿᥐ⨨ Action taken by Issuing Authority: 21.㸨ᥦࡉࢀࡿᥐ⨨ Proposed Action: 22.㏻ሗඖᙜᒁ From (Issuing Authority): 23.㐃⤡ඛ Contact Person: Compliance and Narcotics Division GMP Section Pharmaceutical and Food Safety Bureau FAX: +81-3-3501-0034 Ministry of Health, Labour and Welfare of Japan 24.㸨⨫ྡ Signed: 25.㸨ᖺ᭶᪥ Date: 26.㸨 Time: 㸦ὀព㸧 ࣭ ⏝⣬ࡢࡁࡉࡣࠊ᪥ᮏᕤᴗつ᱁ A4 ࡍࡿࡇ ࣭ ࠕ㸨ࠖࢆࡘࡅࡓ㡯┠ࡣࠊ✵ḍࡋ࡚࠾ࡃࡇࠋ ࣭ ࠕ4.〇ရ Productࠖḍࡣࠊ㈍ྡࡢ࠺ࡕ௦⾲ⓗ࡞ࡶࡢࢆグ㍕ࡍࡿࡶࠊ〇ရ ࡢእᙧⓗ࡞≉ᚩ㸦㸸ࠕwhite tablets㸦ⓑ࠸㘄㸧ࠖ㸧ࢆ⡆༢グ㍕ࡍࡿࡇࠋ ࣭ ࠕ6.㈍ྡ Brand/Trade Nameࠖḍࡣࠊ㈍ྡࢆグ㍕ࡍࡿࡇࠋ᪥ᮏࡣูࡢ㈍ ྡ࡛㈍ࡋ࡚࠸ࡿᅜࡀ࠶ࡿሙྜࡣࠊᅜྡᙜヱᅜ࡛ࡢ㈍ྡࢆิᣲࡍࡿࡇࠋ ࣭ ࠕ7.୍⯡ྡ INN or Generic Nameࠖḍࡣࠊ᭷ຠᡂศࡢ୍⯡ྡࢆグ㍕ࡍࡿࡇࠋ」ᩘ ࡢ᭷ຠᡂศࢆྵ᭷ࡍࡿሙྜࡣࠊิᣲࡍࡿࡇࠋ ࣭ ࠕ19.ὶ㏻ሗ Information on distribution including exportsࠖḍࠊ㍺ฟඛࡢᅜྡࢆグ ධࡍࡿࡇࠋ ࣭ ࠕ4.〇ရ Product:ࠖࠊࠕ6.㈍ྡ Brand/Trade Nameࠖࠊࠕ10.ࣟࢵࢺ␒ྕ Batch/Lot Numberࠖࠊࠕ11.᭷ຠᮇ㝈 Expiry Dateࠖࠊࠕ13.〇㐀ᖺ᭶᪥ Date Manufacturedࠖ➼ࡢ 㛵㐃ࡍࡿ㡯┠ࢆ୍ぴ⾲ࡋࠊู⣬ࡋ࡚♧ࡍࡇ࡛ࡶᕪࡋᨭ࠼࡞࠸ࠋࡑࡢሙྜࠊู⣬ グ㍕ࡋࡓ㡯┠ࡢḍࡣࠕsee the attached fileࠖグ㍕ࡍࡿࡇࠋ ࣭ ᫂࡞ሙྜࡣࠊࠕN/Aࠖグ㍕ࡍࡿࡇࠋ 㸦ู⣬㸲㸧 MINISTRY OF HEALTH, LABOUR AND WELFARE GOVERNMENT OF JAPAN 2-2, KASUMIGASEKI 1-CHOME, CHIYODA-KU, TOKYO 100-8916 . FOLLOW-UP AND NON-URGENT INFORMATION FOR QUALITY DEFECTS 1.㸨ᐄඛ To: 2.㸨ᅇ␒ྕ Recall Number Assigned: 2a.㸨ᅜෆ࠾ࡅࡿᅇ␒ྕ National reference number (When applicable) 4.〇ရ Product: 5.ᢎㄆ␒ྕ Marketing Authorization number: 6.㈍ྡ Brand/Trade name: 7.୍⯡ྡ INN or Generic Name: 8.ᙧ Dosage form: 9.ศ㔞 Strength: 10.ࣟࢵࢺ␒ྕ Batch number (and bulk, if different) 14.ᢎㄆಖᣢ⪅ Marketing Authorization folder: 15.〇㐀ᴗ⪅ Manufacturer: 16.㐃⤡ඛ Contact Person: 17.ヲ⣽ Subject title: 22.㏻ሗඖᙜᒁ From (issuing Authority): 23.㐃⤡ඛ Contact Person: Compliance and Narcotics Division GMP Section Pharmaceutical and Food Safety Bureau FAX: +81-3-3501-0034 Ministry of Health, Labour and Welfare of Japan 24.㸨⨫ྡ Signed: 25.㸨ᖺ᭶᪥ Date: 26.㸨 Time: 㸦ὀព㸧 ࣭ ⏝⣬ࡢࡁࡉࡣࠊ᪥ᮏᕤᴗつ᱁ A4 ࡍࡿࡇ ࣭ ࠕ㸨ࠖࢆࡘࡅࡓ㡯┠ࡣࠊ✵ḍࡋ࡚࠾ࡃࡇࠋ ࣭ ࠕ17. ヲ⣽ Subject titleࠖḍࡣࠊ᪂ࡓุ᫂ࡋࡓᅇᑐ㇟⠊ᅖ㸦ࣟࢵࢺࠊ㍺ฟඛᅜ ➼㸧ࡢሗࢆグ㍕ࡍࡿࡇࠋ