Danish Pharmacovigilance Update, January 2015

10 February 2015

The January issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news:

News from the EU

  • Chlorhexidine may cause skin damage to newborns, page 2
  • Small risk of severe allergic reactions to ambroxol and bromhexine (Flavamed® etc.), page 2
  • EU's list of recommendations on safety signals, page 3

News from the DHMA

  • Atorvastatin and hepatitis, page 4

Short news

  • Most recent Direct Healthcare Professional Communications (DHPCs), page 5
  • New report from the DHMA on monitoring the safety of medicines used off-label in Denmark, page 5
  • Classification of causality assessments, page 5


Danish Pharmacovigilance Update January 2015