About this medicine
- Approved name
- Testosterone-containing medicines
- International non-proprietary name (INN) or common name
- testosterone
About this procedure
- Current status
- CMDh final position
- Reference number
- EMEA/H/A-31/1396
- 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
- 10/04/2014
- PRAC recommendation date
- 09/10/2014
- CHMP opinion date
- 19/11/2014
- Outcome
- Variation