About this medicine
- Approved name
- Nomegestrol and chlormadinone
- International non-proprietary name (INN) or common name
- nomegestrol
- chlormadinone
- Associated names
- Zoely
About this procedure
- Current status
- European Commission final decision
- Reference number
- EMEA/H/A-31/1510
- 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
- 30/09/2021
- PRAC recommendation date
- 07/07/2022
- CHMP opinion date
- 01/09/2022
- EC decision date
- 28/11/2022
- Outcome
- Risk minimisation measures