Danish translation of the PhVWP's recommendation for product information – antiepileptics and possible risk of bone disorder

The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for carbamazepine, phenobarbital, phenytoin, primidone, oxcarbazepine, lamotrigine and sodium valproate.

The Danish National Board of Health has now translated this recommendation into Danish: Antiepileptics and possible risk of bone disorders

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