Paul-Ehrlich-Institut

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Bul­letin on Drug Safe­ty - Cur­rent Is­sue 1/2022 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: development of vaccines and therapies
  • Dabigatran and rivaroxaban: treating and preventing recurrence of venous thromboembolisms in children and adolescents
  • Suspected cases of adverse events and vaccine complications after Comirnaty vaccination among children aged 5-11 in Germany
  • Reports of adverse events in Germany: updates and background
  • PRAC recommendations within the framework of EU referral procedures – January to March 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 1/2022 (German only)
www.pei.de/bulletin-safety

Updated: 30.03.2022