Transcription of NIHS 医薬品安全性情報 Vol.15 No ... - nihs.go.jp
1 1 EU EMA European Medicines Agency methylprednisolone .. 2 PRAC 2017 6 6 9 PRAC .. 4 Health Canada Finasteride .. 7 nihs MedDRA-J nihs 2017 /10/05 nihs nihs nihs 2017 /10/05 2 2017 10/05 R01 EU EMA methylprednisolone CMDh confirms
2 That methylprednisolone injections containing lactose must not be given to patients allergic to cow's milk proteins Referral 2017 /08/01 PRACA CMDhB methylprednisolone EMA PRAC CMDh methylprednisolone Methylprednisolone methylprednisolone methylprednisolone PRAC C methylprednisolone methylprednisolone methylprednisolone CMDh methylprednisolone PRAC Methylprednisolone
3 A Pharmacovigilance Risk Assessment Committee B Co-ordination Group for Mutual Recognition and Decentralised Procedures Human EU C 2001/83/EC 31 2016 12 1 nihs 2017 /10/05 3 PRAC CMDh 2019 methylprednisolone methylprednisolone methylprednisolone methylprednisolone methylprednisolone
4 100 3 methylprednisolone 2019 12 methylprednisolone methylprednisolone Health Canada 2017 9 6 methylprednisolone SOLU-MEDROL ACT-O-VIAL 40 mg nihs 2017 /10/05 4 nihs TGA 2017 /07/27 Methylprednisolone JP Methylprednisolone Sodium Succinate Methylprednisolone Succinate JP Methylprednisolone Acetate 2017 10/05 R02 EU EMA PRAC 2017 6 6 9 PRAC
5 PRAC recommendations on signals adopted at the 6-9 June 2017 PRAC meeting Signal management 2017 /06/22 Web 2017 /07/03 2017 6 6 9 PRAC A PRAC MAHB PRAC CHMPC CMDhD PRAC MAH PRAC EMA PRAC CHMP 2017 6 19 22 MAH A Pharmacovigilance Risk Assessment Committee B marketing authorisation holder C Committee on Medicinal Products for Human Use D Co-ordination Group for Mutual Recognition and Decentralised Procedures Human nihs 2017 /10/05 5 variation CHMP PRAC 1 E INN MAHB Gabapentin
6 EudraVigilance gabapentin MAH SmPCF variation 2 2 E INN MAH Amitriptyline DILI G 2017 8 23 Dasatinib Warfarin Dasatinib warfarin ADR H PSURI 2017 9 5 Ledipasvir/Sofosbuvir PSUR 2017 9 27 mTOR Everolimus Sirolimus Temsirolimus 2017 8 23 E F summary of product characteristics G drug induced liver injury H adverse drug reaction I Periodic Safety Update Report nihs 2017 /10/05 6 3 E INN MAH Dabigatran Simvastatin lovastatin Dabrafenib Trametinib J Docetaxel Docetaxel
7 ADR H docetaxel ADR / Prednisolone Prednisone PRAC MAH 2017 6 23 Telmisartan Telmisartan/ Hydrochlorothiazide Telmisartan/Amlodipine PRAC Questions and Answers on signal management J routine pharmacovigilance nihs 2017 /10/05 7 2017 10/05 R03 Health Canada Finasteride Summary Safety Review - Finasteride - Assessing the Potential Risk of Serious Muscle-Related Side Effects Safety Reviews 2017 /06/22 Finasteride Health Canada finasteride Propecia Proscar Health Canada finasteride finasteride
8 Health Canada finasteride Health Canada Propecia Proscar Finasteride 5 mg Finasteride 1 mg finasteride 5 mg Proscar 1992 finasteride 1 mg Propecia 1998 Finasteride nihs 2017 /10/05 8 A Health Canada finasteride 11 4 1 1 2 1 finasteride
