Translation of the PhVWP's recommendation for product information – proton-pump inhibitors' class effects on magnesium blood levels from long-term use

The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information concerning the class effects of proton-pump inhibitors (dexlansoprazole, esomeprazole, lansoprazole, omeprazole, rabeprazole, pantoprazole) on magnesium blood levels from long-term use.

The Danish Health and Medicines Authority has now translated this recommendation into Danish: Proton-pump inhibitors' class effects on magnesium blood levels from long-term use

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