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SGLT2 inhibitors: initiation of a European safety review to evaluate the risk of diabetic ketoacidosis

2015.06.16

Active substance: canagliflozin | dapagliflozin | empagliflozin

The BfArM issues information on the initiation of a European safety review according to Article 20 of Regulation (EC) No. 726/2004 regarding SGLT2 inhibitors.

To the risk assessment procedure (available in German only)

Details on the procedure can be found on the website of the European Medicines Agency (EMA):

SGLT2 inhibitors