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Ministry of Health warns active ingredient Valsartan contains potentially toxic impurities
Digempas was the subject of further investigation and was able to verify that none of the products declared by EMA and AEMPS has been imported into the national territory.
Photo : Acento.com.do/Archivo
Santo Domingo (EFE) – The Ministry of Public Health has warned against the detection of a potentially cytotoxic impurity (N-nitrosodimethylamine) in the pharmaceutical ingredient Valsartan, as a result of a modification of the manufacturing process of this active ingredient.
The warning is based on statements published by the European Medicines Agency (EMA) and by the Spanish Agency for Medicines and Health Products (AEMPS). that the manufacturer has detected the aforementioned impurity.
The Directorate General of Medicines, Food Products and Health (Digemaps) of the Ministry instructed owners of medicines registered in the country to refrain from acquiring and using the drug. active ingredient Valsartan, developed by the Chinese company Zhejiang Juahai Pharmaceutical CO. LTD.
Digempas was the subject of further investigation and was able to verify that none of the products reported by the EMA and the AEMPS had been imported on the national territory.
However, following the investigation of other regulatory bodies, it was possible to identify that products registered to be marketed in the country that contain the potentially cytotoxic impurity (N -nitrosodiméthylamine).
Digemaps is in the process of checking the raw material for the manufacture of products that are developed in the country with the above active ingredient, and will inform citizens in a timely manner about the results of this investigation.
Similarly, he encourages people who have an adverse event associated with treatment with valsartan, to report it to the health authorities EFE
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