About this medicine
- Approved name
- Zolpidem-containing medicines
- International non-proprietary name (INN) or common name
- zolpidem
About this procedure
- Current status
- European Commission final decision
- Reference number
- EMEA/H/A-31/1377
- 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
- Nationally authorised product(s)
- Decision making model
- PRAC-CMDh
Key dates and outcomes
- Procedure start date
- 11/07/2013
- PRAC recommendation date
- 06/03/2014
- CHMP opinion date
- 24/04/2014
- EC decision date
- 23/06/2014
- Outcome
- Risk minimisation measures