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

The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for SSRIs (fluvoxamine, citalopram, escitalopram, fluoxetine, sertraline and paroxetine). The Danish Health and Medicines Authority has now translated this recommendation into Danish:

SSRIs – fluvoxamine, citalopram, escitalopram, fluoxetine, sertraline and paroxetine

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