Revised Danish translation of the PhVWP's recommendation for the product information of rosuvastatin (Crestor)

The European Pharmacovigilance Working Party, PhVWP, has revised its recommendation for the wording of the product information for rosuvastatin.

The undesirable effect “gynecomastia” has been revised to only involve men.

The Danish National Board of Health has now translated this recommendation into Danish: Rosuvastatin and risk of gynecomastia - revised (pdf)

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