Danish translation of the PhVWP's recommendation for the product information of topiramate

The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for topiramate-containing medicines. The Danish Health and Medicines Authority has now translated this recommendation into Danish: Topiramate and risk of congenital malformations.

The text is used to prepare new product information. Furthermore, marketing authorisation holders of topiramate-containing medicines must implement the new text by submitting variation applications for all relevant products.