Danish Pharmacovigilance Update, October 2014

11 November 2014

News from the EU

  • EU's Pharmacovigilance Risk Assessment Committee (PRAC) recommends strengthening the restrictions on the use of the epileptic medicine valproate (Deprakine etc.) in women and girls, page 2
  • Monitoring of liver function during treatment with agomelatine (Valdoxan), page 3
  • EU's list of recommendations on safety signals, page 4

News from the DHMA

  • Ethambutol and effects on vision, page 5
  • Safety of products containing botulinum toxin (Botox® etc.) and fillers for cosmetic treatment, page 6

News in brief

  • Most recent Direct Healthcare Professional Communications (DHPCs), page 9
  • Domperidone and new dosage recommendations – clarification of DHPC, page 9

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