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China-made medicines with Valsartan to be withdrawn

Update: July, 11/2018 - 15:26
Photo for illustration. – Photo
Viet Nam News

HÀ NỘI — The Drug Administration under the Ministry of Health on Tuesday tasked all provincial departments of health and medicine manufacturers and pharmacies to suspend the circulation of all types of medicine containing Valsartan by the China-based Zhejiang Huahai Pharmaceutical Company indicated in a designated list, the Vietnam News Agency reports.

The decision was given following the previous announcements of the European Medicines Agency (EMA), Health Canada and other medical management authorities on the withdrawal of Valsartan-containing medicines produced by the mentioned company.

The material was detected to contain N-Nitrosodimethylamine (NDMA), a substance that can cause cancer. Simultaneously, the administration also suspended the use of Valsartan in producing medicines and is conducting research on the use and impact of Valsartan to ensure patients’ safety and follow the procedures for changing drug registration dossiers as regulated.

Companies are also asked to submit their reports of withdrawal to the administration within one month. The report of withdrawal includes shipments, withdrawal quantity and other evidence of withdrawal at wholesalers, retailers and users who have purchased drugs according to the regulations of the Ministry of Health. Provincial departments of health are responsible for notifying medical facilities and pharmacies about the withdrawal and announcing it on their websites.

They are also in charge of tightening the management of the process and handling any violations that occur. — VNS

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