The EMA launched a safety review of ranitidine-based medicines upon the European Commission’s request on 13 September, after tests found the presence of NDMA in some of these medicines. In this regard, evaluations are underway by the European Medicines Agency (EMA) in collaboration with AIFA and other European and international medicines agencies.
AIFA and the other national agencies have ordered restrictive measures in their respective States and are collaborating with the EMA. AIFA has ordered the withdrawal from pharmacies and the distribution chain of all batches of medicines containing ranitidine produced at the SARACA LABORATORIES LTD pharmaceutical workshop.
It also ordered a precautionary ban on the use of all batches marketed in Italy of medicines containing ranitidine produced by other pharmaceutical companies, pending their analysis. AIFA communicated the withdrawal and prohibition of use measures to doctors and pharmacists, issued a press release and shared information on its social channels. All updated information is available on the institutional portal.