About this medicine
- Approved name
- Omega-3 acid ethyl esters - containing medicinal products for oral in use in secondary prevention after myocardial infarction
- International non-proprietary name (INN) or common name
- Omega-3 fatty acid ethyl esters
About this procedure
- Current status
- European Commission final decision
- Reference number
- EMEA/H/A-31/1464
- 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)
Key dates and outcomes
- CHMP opinion date
- 13/12/2018
- EC decision date
- 06/06/2019