Companies holding marketing authorization for non-steroidal anti-inflammatory drugs (NSAIDs) for systemic use, both as monocomponents and in combination, authorized with national procedures or for which Italy acts as RMS, are reminded to update the printed matter in accordance the recommendations of the CMDh (Co-ordination group for Mutual recognition and Decentralized procedures - human) "NSAID-containing medicinal products (for systemic use) and use during pregnancy" accessible from "Related links".
To this end, the AIC holders of the mentioned medicines must submit a variation application to the AIFA Post-Authorization Procedures Office, pursuant to EC Regulation No. 1234/2008 and subsequent amendments.
If the currently authorized product information contains more restrictive warnings on use in pregnancy than those reported in the CMDh press release, the more restrictive warnings must be maintained.
Further clarifications on how to submit applications and the texts (in English) to be implemented in the Product Information (RCP and FI) are available in the press release of the CMDh.
In the variation application it must be specified that the request comes from the Pharmacovigilance Office.
If the variation mentioned has already been submitted, please disregard this communication; otherwise, companies that have not yet complied are requested to proceed with the presentation of the change within the deadlines indicated in the press release.
Source: AIFA
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