About this medicine
- Approved name
- Methotrexate containing medicinal products
- International non-proprietary name (INN) or common name
- methotrexate
- Associated names
- Nordimet
- Jylamvo
- Jylamvo
- Nordimet
- Ledertrexate
- Maxtrex
- Metex
- Metoject
About this procedure
- Current status
- European Commission final decision
- Reference number
- EMEA/H/A-31/1463
- 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
- Centrally and nationally authorised products (mixed)
- Decision making model
- PRAC-CHMP-EC
Key dates and outcomes
- Procedure start date
- 12/04/2018
- PRAC recommendation date
- 11/07/2019
- CHMP opinion date
- 22/08/2019
- EC decision date
- 21/10/2019
- Outcome
- Risk minimisation measures