The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for prescription-only proton-pump inhibitors (omeprazole esomeprazole/naproxen, omeprazole/ketoprofen, esomeprazole, lansoprazole, pantoprazole, rabeprazole) and risk of fractures of the hip, wrist and spine.
The Danish Health and Medicines Authority has now translated this recommendation into Danish: Prescription-only proton pump inhibitors (omeprazole esomeprazole/naproxen, omeprazole/ketoprofen, esomeprazole, lansoprazole, pantoprazole, rabeprazole) and risk of fractures of the hip, wrist and spine
The text is used to prepare new product information. Furthermore, marketing authorisation holders of prescription-only proton-pump inhibitors must implement the new text by submitting variation applications for all relevant products.
