Statins, modifications to product information

Following the recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA, the Pharmacovigilance Office of the Italian Medicines Agency has requested amendments to the printed materials of medicinal products based on atorvastatin, rosuvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin and simvastatin.  The variation application to include the reporting of immune-mediated necrotizing myopathy in paragraphs 4.4 (Special warnings and precautions for use) and 4.8 Undesirable Effects) of the SPC and the corresponding paragraphs 2 and 4 of the Package Leaflet, must be submitted by the 29th March, 2015 for all products authorized nationally or via the mutual recognition/decentralized procedure with Italy as the Reference Member State (RMS). The modifications must be introduced immediately into the SmPC and no later than six months after the publication of the variation in the Official Gazette for the package leaflet. Batches manufactured at the date of publication in the Journal without authorized modifications may remain on the market until the expiry date given on the label of the medicine. The updated Package Leaflet will be provided by the pharmacists for users as of 30 days from the date of publication of the variation. The marketing authorization holder will make the updated Package Leaflet available to the pharmacists within the same period. Marketing authorization holders of parallel import of medicines for systemic use containing the concerned active ingredients must comply with the indications no later than 30 days following the outcome of the adaptation of the product information by Italian marketing authorization holders. The amendments to be made are available on the EMA website.