MAHs of non-steroidal anti-inflammatory drugs (NSAIDs) for systemic use, including fixed dose combinations, authorized via national procedures or for which Italy is RMS, are reminded of their obligation to update the product information in accordance with the recommendations of the CMDh ("Related links").

These MAHs should submit a variation application to the AIFA Post-Authorization Procedures Office, pursuant to EC Regulation No. 1234/2008 and subsequent amendments.

Of note, in case the product information already includes a stricter advice on use in pregnancy, the stricter advice remains valid and should remain.

Further details on the submission of the applications and the texts to be implemented are reported in the CMDh press release. In the cover page it should be mentioned that the request comes from the Pharmacovigilance Office.

If the mentioned variation has already been submitted, please disregard this communication; otherwise, MAHs that have not yet complied should submit the variation in accordance to the timelines reported in the CMDh Press Release.