Paul-Ehrlich-Institut

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Bulletin on Drug Safety – Current Issue 2/2024 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: Pharmacovigilance perspectives
  • False-positive amphetamine test on methyldopa
  • Bottle design improvement and label change intended to help prevent octenisept® misuse and confusion
  • Reports from BfArM and PEI
  • PRAC recommendations within EU referral procedures – April to June 2024
  • Revised product information wording – Extracts from the PRAC recommendations on signals
  • References to direct healthcare professional communications (Rote-Hand-Briefe) and safety information

Further Information

Bulletin on Drug Safety, Issue 2/2024 (German only)
www.pei.de/bulletin-safety

Updated: 27.06.2024