About this medicine
- Approved name
- Esmya
- International non-proprietary name (INN) or common name
- ulipristal acetate
- Associated names
- Esmya
About this procedure
- Current status
- European Commission final decision
- Reference number
- EMEA/H/A-20/1460/C/2041/0043
- 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
- 30/11/2017
- PRAC recommendation date
- 17/05/2018
- CHMP opinion date
- 31/05/2018
- EC decision date
- 26/07/2018
- Outcome
- Risk minimisation measures