Glatiramer – Scientific Conclusions and Basis for Modification of Registration Approval Terms – PSUSA-00001529-202011

November 23rd, 2021|0 Comments

In view of the available evidence of severe liver damage from clinical trials and spontaneous reports, including in some cases a close temporal relationship, positive withdrawal, and/or re-challenge, PRAC believes that a causal relationship between [...]

Information letter No. 01I-1468/21 of 09.11.2021 on introduction of new safety info into the instruction for use of the drug Baeta® (INN – Exenatide)

November 23rd, 2021|0 Comments

New data on the efficacy and safety of the drug were obtained, therefore significant changes were made to the Instructions for Medical Use (SMPC), including the sections Pharmacodynamics, Pharmacokinetics, Indications for use, Use during pregnancy [...]

Information letter from 09.11.2021 № 01I-1463/21 On the results of state quality control of the drug “Amiodarone”

November 23rd, 2021|0 Comments

Federal Service for Surveillance in Healthcare reports information about the detection of the drug "AMIODARON, concentrate for preparation of solution for intravenous injection 50 mg/ml 3 ml, ampoules (10), packs of cartons, series 080519 manufactured [...]