Transcription of 医薬品安全性情報 Vol.10 No.06 2012/03/15
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医薬品安全性情報 Vol.10 No.06 2012/03/15
1 I FDA U. S. Food and Drug Administration FDA/CDER 2012 1 .. 2 EU EMA European Medicines Agency Orlistat / .. 6 Aprotinin .. 8 Aliskiren EMA .. 10 MHRA Medicines and Healthcare products Regulatory Agency Drug Safety Update Vol. 5 No. 7 2012 .. 12 Health Canada Vandetanib Caprelsa QTc .. 13 1 2 MedDRA-J 2012/03/15 2012/03/15 2 I 2012 03/15 R01 FDA FDA/CDER 2012 1 2012 Summary view: safety labeling changes approved by FDA Center for Drug Evaluation and Research CDER January FDA MedWatch 2012/02/17 A BW boxed warning C contraindications W warnings P precautions
* Anti-Hypertensive Drugs ; . ; . Accuretic （quinapril HCl/ hydrochlorothiazide） 10/12.5 mg, 20/12.5 mg, 20/25 mg Tablets * Anti-Hypertensive Drugs
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