About this medicine
- Approved name
- Janus kinase inhibitors (JAKi)
- International non-proprietary name (INN) or common name
- tofacitinib
- abrocitinib
- baricitinib
- upadacitinib
- filgotinib
- Associated names
- Xeljanz
- Cibinqo
- Olumiant
- Rinvoq
- Jyseleca
- Xeljanz
About this procedure
- Current status
- European Commission final decision
- Reference number
- EMEA/H-A20/1517/C/004214/0048; EMEA/H-A20/1517/C/005452/0003; EMEA/H-A20/1517/C/004085/0032; EMEA/H-A20/1517/C/004760/0017; EMEA/H-A20/1517/C/005113/0014
- 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
- 10/02/2022
- PRAC recommendation date
- 12/01/2023
- CHMP opinion date
- 23/01/2023
- EC decision date
- 10/03/2023
- Outcome
- Risk minimisation measures