About this medicine
- Approved name
- Ulipristal acetate 5mg medicinal products
- International non-proprietary name (INN) or common name
- ulipristal acetate
- Associated names
- Esmya
- Ulipristal Acetate Gedeon Richter
- Class
- Progesterone receptor modulators
About this procedure
- Current status
- European Commission final decision
- Reference number
- EMEA/H/A-31/1496
- Type
- Article 31 referrals
This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.
- Authorisation model
- Centrally and nationally authorised products (mixed)
- Decision making model
- PRAC-CHMP-EC
Key dates and outcomes
- Procedure start date
- 12/03/2020
- PRAC recommendation date
- 04/09/2020
- CHMP opinion date
- 12/11/2020
- EC decision date
- 11/01/2021