Danish Pharmacovigilance Update, January 2016

10 February 2016

News from the EU

  • EU's list of recommendations on safety signals, page 2

News from the Danish Medicines Agency

  • Safety monitoring following switch from Gardasil® to Cervarix® as HPV vaccine in the childhood immunisation programme, page 3
  • ADHD medicines and cardiovascular adverse reactions, page 4
  • Healthcare professionals to observe new rules on the monitoring of biological medicines and biosimilars, page 12
  • Intrauterine exposure to paracetamol and effect on fertility, page 13
  • SSRIs and tricyclic antidepressants, dry mouth and oral cavities, page 15

Short news

  • Most recent Direct Healthcare Professional Communications (DHPCs), page 16


Danish Pharmacovigilance Update, January 2016