About this medicine
- Approved name
- Amfepramone-containing medicinal products
- International non-proprietary name (INN) or common name
- amfepramone
- Associated names
- Regenon
- Tenuate Retard
- Amfepramon-Hormosan
- Regenon Retard
About this procedure
- Current status
- European Commission final decision
- Reference number
- EMEA/H/A-31/1501
- 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
- 11/02/2021
- PRAC recommendation date
- 27/10/2022
- CMDh position date
- 10/11/2022
- EC decision date
- 13/01/2023
- Outcome
- Revocation