BfArM - Federal Institute for Drugs and Medical Devices

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SGLT2 inhibitors (prviously canagliflozin): possibly increased risk of lower-extremity amputations

2017.02.10

Active substance: Canagliflozin | Dapagliflozin | Empagliflozin

10.02.2017 – PRAC recommendation

The BfArM issues information on the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC)

12. 07.2016 – Extension of the review to all SGLT2 inhibitors

The BfArM issues information on the extension of the European safety review regarding canagliflozin to include all SGLT2 inhibitors.

15.04.2016 – Procedure started

The BfArM issues information on the initiation of a European safety review regarding canagliflozin.

Further information

For details regarding the procedure please click on the following link to the European Medicines Agency (EMA):

SGLT2 inhibitors (previously Canagliflozin)

To the risk assessment procedure (available in German only)