EMA update on metformin diabetes medicines

December 6, 2019 – EMA is aware that trace amounts of an impurity, N-nitrosodimethylamine (NDMA), have been found in a small number of metformin diabetes medicines outside the EU. The levels of NDMA in the affected non-EU metformin medicines are very low and appear to be within or even below the range that people can be exposed to from other sources, including certain foods and water. At this point, there are no data indicating that EU metformin … (leggi tutto)