Paul-Ehrlich-Institut

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Bul­letin on Drug Safe­ty - Cur­rent Is­sue 1/2021 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 on current aspects of the assessment of drugs from both federal institutes. 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 language.

Topics of the Current Issue

  • Editorial: COVID-19 Vaccines - pharmacovigilance systems work
  • First-generation antihistamines - risk aspects in the elderly and discussion on classification for supply
  • Fluoroquinolones and their risk for valvular regurgitation/insufficiency - new product information warning
  • COVID-19 vaccines - overview of vaccine types approved or in the process of approval in Europe
  • What needs to be considered in case of positive allergy history before vaccination against COVID-19?
  • Reports from BfArM and PEI
  • PRAC recommendations within the framework of EU referral procedures – January to March 2021
  • Revision of the product information wording
  • References to ‘Dear Doctor Letter’ (Rote-Hand-Brief) and safety information

Further Information

Bulletin on Drug Safety, Issue 1/2021 (German only)
www.pei.de/bulletin-safety

Updated: 08.04.2021