Transcription of 平成 28 30 - pmda.go.jp
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29 17 .. 28 30 .. 29 .. 29 1 18 .. mg .. 28 3 30 . 1 mg . 1 .. C32H34N4O6 C7H8O3S.. (5R)-17-( )-6,7- -4,5- -3,6,14- -N- [2-(3- -1,2,4- -5- ) -2- ] -7- . (4- ).. (5R)-17-(cyclopropylmethyl)-6,7-didehydr o-4,5-epoxy-3,6,14-trihydroxy-N-[2-(3-ph enyl-1,2,4- oxadiazol-5-yl)propan-2-yl]morphinan-7-c arboxamide mono(4-methylbenzenesulfonate).. 1 mg 1 1 .. 2.. 1 . 28 11 30 .. mg .. 28 3 30 . 1 mg .. 1 mg 1 1 .. 1. 1.. 4. 2.. 4. 3.. 6. 4.. 11. 5.. 15. 6.. 21. 7.. 35. 8.. 59. 9. 1 .. 59.. ALP Alkaline phosphatase . ALT Alanine aminotransferase . AST Aspartate aminotransferase . AUC Area under concentration-time curve . AUC0-24h Area under concentration-time curve 0 24 . up to 24 hours AUC0- Area under concentration-time curve . during dose interval.
審査報告書 平成29 年1 月18 日 独立行政法人医薬品医療機器総合機構 承認申請のあった下記の医薬品にかかる医薬品医療機器総合機構での審査結果は、以下のとおりであ
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