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The General Directorate of Drugs, Supplies and Drugs (Digemid), Ministry of Health (Minsa), ordered the withdrawal of 33 products containing valsartan (active ingredient used for hypertension in response to alerts issued by the European Medicines Agency (EMA) and the Spanish Agency for Medicines and Health Products (AEMPS), which warned of finding a probable impurity carcinogen.
The measurement was made after detection of N-nitrosodimethylamine (NDMA)) in the active ingredient of Valsartan manufactured by the Chinese company Zhejing Huahai Pharmaceutical Co. Ltd. This impurity was generated as a result of a modification of the manufacturing process of valsartan in several presentations.
In order to preserve the health of the population, Digemid has contacted the laboratories and pharmacies that hold the sanitary registers of the products that contain in their composition valsartan, having identified 104 batches of 33 products, which have been immobilized and will be removed of the national market, as stated in the alert no. 35-2018 published on its web portal.
the Digemid informed health professionals that, in the case of patients undergoing treatment with one of the drugs Valsartan they should replace it with another one that is not not included in the alert.
to health facilities that have these products at risk, immobilize them and contact their suppliers for the corresponding actions.
Digemid has recommended that patients do not interrupt their treatments and consult their doctor or pharmacist to inform them if your medications are being withdrawn from the market and replaced by a drug from a batch that does not come into the market. is not contaminated by this impurity of the NDMA.
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