About this medicine
- Approved name
- Topiramate
- International non-proprietary name (INN) or common name
- topiramate
About this procedure
- Current status
- CMDh final position
- Reference number
- EMEA/H/A-31/1520
- 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
- 01/09/2022
- PRAC recommendation date
- 31/08/2023
- CMDh position date
- 10/11/2023