About this medicine
- Approved name
- Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group
- International non-proprietary name (INN) or common name
- valsartan
- candesartan
- irbesartan
- losartan
- olmesartan
- Associated names
- Karvezide
- Karvea
- Irbesartan/Hydrochlorothiazide Teva
- Irbesartan Zentiva (previously Irbesartan Winthrop)
- Irbesartan Teva
- Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)
- Ifirmasta (previously Irbesartan Krka)
- Ifirmacombi
- Aprovel
- Neparvis
- Exforge
- Exforge HCT
- Entresto
- Dafiro HCT
- Dafiro
- Copalia HCT
- Copalia
- Amlodipine / Valsartan Mylan
- CoAprovel
- Class
- angiotensin-II-receptor antagonist
About this procedure
- Current status
- European Commission final decision
- Reference number
- EMEA/H/A-31/1471
- 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)
Key dates and outcomes
- CHMP opinion date
- 12/11/2020
- EC decision date
- 19/02/2021