About this medicine
- Approved name
- Combined hormonal contraceptives
- International non-proprietary name (INN) or common name
- desogestrel
- gestodene
- norgestimate
- etonogestrel
- drospirenone
- dienogest
- chlormadinone
- nomegestrol
- norelgestromin
- Class
- -
About this procedure
- Current status
- European Commission final decision
- Reference number
- EMEA/H/A-31/1356
- 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
- 07/02/2013
- PRAC recommendation date
- 10/10/2013
- CHMP opinion date
- 16/01/2014
- Outcome
- Risk minimisation measures