Danish Pharmacovigilance Update, April 2016

10 May 2016

News from the EU

  • The European Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of the risk of amputations in connection with canagliflozin treatment
  • EU's list of recommendations on safety signals

News from the Danish Medicines Agency

  • Reports of cardiac arrest after treatment with methylphenidate
  • Influenza vaccines and reports of suspected adverse reactions

Short news

  • Most recent Direct Healthcare Professional Communications (DHPCs)
  • Information material for healthcare professionals and patients about biological medicines and biosimilars


Danish Pharmacovigilance Update April 2016 (pdf)