Current Information on the Safety of Medicinal Products: Decisions of Foreign Regulatory Authorities

Abstract

The experts of the Department for Medicine Safety Evaluation of the Scientific Centre for Expert Evaluation of Medicinal Products analysed administrative decisions of international pharmacovigilance regulatory authorities on the necessary labelling updates. The analysis revealed 16 decisions containing safety updates for the following medicines registered in Russia: avatrombopag, amphotericin B, acetazolamide, belimumab, bendamustine, hydrocortisone, dabrafenib, dexamethasone, denosumab, ibuprofen, cortisone, prednisolone, trametinib, nilotinib, pirfenidone, and cefotaxime.

Keywords

• adverse drug reactions
• post-marketing studies
• drugs
• labeling, foreign regulatory authorities, pharmacovigilance