About this medicine
- Approved name
- Valproate and related substances
- International non-proprietary name (INN) or common name
- sodium valproate
- valproic acid
- valproate semisodium
- valpromide
- Associated names
- Absenor
- Convival Chrono
- Convulex
- Convulsofin Tabletten
- Delepsine
- Depakine
- Deprakine
- Diplexil
- Dipromal
- Epilim
- Episenta
- Epival
- Ergenyl
- Espa-Valept
- Hexaquin
- Leptilan
- Micropakine L.P.
- Orfiril
- Orlept
- Petilin
- Valberg
- Valepil and Valhel
About this procedure
- Current status
- CMDh final position
- Reference number
- EMEA/H/A-31/1387
- 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
- 10/10/2013
- PRAC recommendation date
- 09/10/2014
- CHMP opinion date
- 19/11/2014
- Outcome
- Risk minimisation measures