Ifirmasta (previously Irbesartan Krka) (irbesartan)
Generic
- Region
- 🇪🇺 EU
- Active substance
- irbesartan
- Company
- KRKA tovarna zdravil d.d. Novo mesto
- Status
- Authorised
- Therapeutic area
- Hypertension
- CHMP opinion
- Thu 25 Sep 2008
- EU approval
- Mon 01 Dec 2008
- Designations
- Generic
- Application
- EMEA/H/C/000962
- ATC
- C09CA04
- Official record
- www.ema.europa.eu
Indication
Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop) Authorised · sanofi-aventis groupe
- 🇪🇺 Irbesartan Zentiva (previously Irbesartan Winthrop) Authorised · Zentiva k.s.
- 🇪🇺 Irbesartan Teva Authorised · Teva B.V.
- 🇪🇺 Ifirmacombi Authorised · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Karvea Authorised · Sanofi Winthrop Industrie
- 🇪🇺 Irbesartan/Hydrochlorothiazide Teva Authorised · Teva B.V.
- 🇪🇺 Aprovel Authorised · Sanofi Winthrop Industrie
- 🇪🇺 Karvezide Authorised · Sanofi Winthrop Industrie
- 🇪🇺 CoAprovel Authorised · Sanofi Winthrop Industrie
- 🇪🇺 Sabervel Expired · Pharmathen S.A.
- 🇪🇺 Irbesartan BMS Withdrawn · Bristol-Myers Squibb Pharma EEIG
- 🇪🇺 Irbesartan Hydrochlorothiazide BMS Withdrawn · Bristol-Myers Squibb Pharma EEIG
Follow Ifirmasta (previously Irbesartan Krka)
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.