Новости и публикации
Free scientific and practical webinar on pharmacovigilance issues
Dear colleagues! We invite you to participate in a free-of-charge scientific and practical webinar [...]
Intravenous Iron preparation: CMDh Scientific Conclusions and Reasons for Deviations, Amendments to Product Information and Implementation Schedule — EMEA / H / N / PSR / J / 0026
Based on PRAC's review of the final PASS Study Report Version 1.1, PRAC believes [...]
Information letter No. 01I-1430/21 of 26.10.2021 on the introduction of new safety data in the instructions for use of the drug Nexium® (INN — Esomeprazole) 10 mg
The following sections of the instructions for medical use of the drug have been [...]
Carbamazepine — Scientific Findings and Basis for Modification of Registration Approval — PSUSA-00000539-202012
PRAC proposes the following changes to the Smpc: Interaction with brivaracetam Hyperammonemia Use during [...]
Warfarin — anticoagulant-related nephropathy
PRAC analyzed pooled data from spontaneous case reports, clinical trials, and the literature regarding [...]
Cefoperazone — Scientific Conclusions and Basis for Modification of Registration Approval Terms — PSUSA-00000597-202101 (Hematuria)
In view of the available data on coagulopathy and bleeding from clinical trials, literature, [...]