Bulletin on Drug Safety - Current Issue 2/2022 Published
The Bulletin on Drug Safety is a cooperation between the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) and the Paul-Ehrlich-Institut (PEI). The quarterly publication provides information from both federal institutes on current aspects of the assessment of drugs. It focuses on pharmacovigilance – the continuous monitoring and evaluation of drug safety before and after marketing authorisation. The Bulletin includes articles on individual drugs as well as background information for understanding pharmacovigilance and research in this area.
The publication is available in German only.
Topics in the Current Issue
- Editorial: The SARS-CoV-2 pandemic and new tasks for BfArM and Paul-Ehrlich-Institut
- Temporal trend of prescribing antiepileptic drugs in Germany
- Accidental transfer of topically applied sex hormones to children and pets
- Nuvaxovid® – suspected adverse events reported in the first three months since the start of vaccination with this vaccine
- Farewell to “-mab” – new international nonproprietary names (INN) for monoclonal antibodies
- T-type Ca2 + channel blockers and Alzheimer's – new preclinical findings, translational pharmacotherapeutic aspects and potential pharmacovigilance implications
- Reports from BfArM and PEI
- PRAC recommendations within the framework of EU referral procedures – April to June 2022
- Revision of product information wording – excerpts from the PRAC recommendations on signals
- References to ‘Dear Doctor Letters’ (Rote-Hand-Briefe) and safety information
Further Information
Bulletin on Drug Safety, Issue 2/2022 (German only)
www.pei.de/bulletin-safety