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Review of common medicines used to treat hypertension – valsartan – due to detection of impurity, N-nitrosodimethylamine (NDMA), a probable human carcinogen! (Part IV)

  • 19 сентября 2018
  • active substance, API, cancer, carcinogen, CEP, EDQM, EMA, headspace GC/MS, human, hypertension, impurity, inspection, investigation, manufacturer, manufacturing, manufacturing site, medicinal product, medicines, method, N-nitrosodimethylamine, NDEA, NDMA, nitrosamine, N‑nitrosodiethylamine, OMCL, patient, process, recall, review, risk, sartans, test, valsartan, Zhejiang Huahai Pharmaceuticals, Zhejiang Tianyu Pharmaceutical Co. Ltd.,
EMA   The European Medicines Agency (EMA) has updated its calculation of the risk from valsartan medicines containing N‑nitrosodimethylamine (NDMA), taking into account results from latest tests on the active substance from Zhejiang Huahai. In addition to NDMA, EMA is assessing the impact of a related substance, N‑nitrosodiethylamine (NDEA), which has been detected in valsartan
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