Ranitidine medication withdrawn from Serbian market

Due to the warning issued by the European Medicines Agency, the medication ranitidine is being withdrawn from the Serbian market. Out of precaution, in order to protect the public health of the population of the Republic of Serbia, Hemofarm A.D. has issued a decision on the voluntary, preventive withdrawal of all the batches of Ranitidine from the market. To Hemofarm, as a responsible company, patients’ safety comes first, Hemofarm said in a statement. Ranitidine contains the active substance ranitidine hydrochloride, and according to the warning by the European Medicines Agency, impurities called N-nitrosodimethylamine (NDMA) have been detected in the abovementioned active substance. A document issued by the European Medicines Agency (EMA) raises concern about the possible adverse impact of the detected amount of NDMA impurity on human health, which will be confirmed or refuted in subsequent studies. The European Medicines Agency, in close cooperation with the national medicines agencies, will check all the finished medicines containing the active substance ranitidine hydrochloride from different manufacturers. The check began on 12 September and it is being implemented by the Committee for Medicinal Products for Human Use (CHMP), whose findings will be legally binding on all EU countries, and Hemofarm, which operates in accordance with European principles, will also comply with them, the statement says.

Izvor: BIZLife

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