Translation of the PhVWP's recommendation for product information concerning use of antipsychotics during pregnancy

The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for antipsychotics. The Danish Medicines Agency has now translated this recommendation into Danish.

The translation is available in the box to the right. The text is used to prepare new product information.

Furthermore, marketing authorisation holders of antipsychotics must implement the new text by submitting variation applications for all relevant products.