About this medicine
- Approved name
- SGLT2 inhibitors (previously canagliflozin)
- International non-proprietary name (INN) or common name
- canagliflozin
- empagliflozin
- dapagliflozin
- metformin
- Associated names
- Xigduo
- Ebymect
- Edistride
- Synjardy
- Forxiga
- Jardiance
- Vokanamet
- Invokana
- Invokana
- Vokanamet
- Jardiance
- Synjardy
- Forxiga
- Edistride
- Xigduo
- Ebymect
About this procedure
- Current status
- European Commission final decision
- Reference number
- EMEA/H/A-20/1442
- Type
- Article 20 procedures
This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues.
- Authorisation model
- Centrally authorised product(s)
- Decision making model
- PRAC-CHMP-EC
Key dates and outcomes
- Procedure start date
- 15/04/2016
- PRAC recommendation date
- 09/02/2017
- CHMP opinion date
- 23/02/2017
- EC decision date
- 04/05/2017
- Outcome
- Risk minimisation measures