Danish translation of the PhVWP's revised recommendation for the product information of fluoroquinolones

The European Pharmacovigilance Working Party, PhVWP, has prepared a revised recommendation for the wording of the product information for fluoroquinolones.

The Danish Health and Medicines Authority has now translated this recommendation into Danish: Fluoroquinolones and risk of QT-interval prolongation.

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