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Metformin diabetes medicines and N-nitrosodimethylamine (NDMA) – a probable human carcinogen

  • 7 December 2019
  • acceptable, active substance, AI, API, authority, cancer, carcinogen, CEP, daily, diabetes, drug, drug product, EDQM, EMA, EU, FDA, GMP, HCl, HSA, human, hydrochloride, ICH M7, impurity, intake, investigation, manufacturing process, market, medicinal product, medicines, metformin, N-nitrosodimethylamine, NDMA, nitrosamine, recall, root cause, Streuli Pharma AG, Swissmedic, type 2, withdrawal,
    NEW! URGENT! Update [19/10/2020] EMA and EU national competent authorities will be contacting all marketing authorisation holders of metformin-containing medicines, used for the treatment of diabetes, to request they implement testing of the medicines for the presence of nitrosamines before they are released onto the market. This is a precautionary step to ensure
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