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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)