Irbesartan/Hydrochlorothiazide Teva (irbesartan;hydrochlorothiazide)
Generic
- Region
- 🇪🇺 EU
- Active substance
- irbesartan;hydrochlorothiazide
- Company
- Teva B.V.
- Status
- Authorised
- Therapeutic area
- Hypertension
- CHMP opinion
- Thu 24 Sep 2009
- EU approval
- Thu 26 Nov 2009
- Designations
- Generic
- Application
- EMEA/H/C/001112
- ATC
- C09DA04
- Official record
- www.ema.europa.eu
Indication
Treatment of essential hypertension. This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
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
- 🇪🇺 Ifirmacombi Authorised · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Karvezide Authorised · Sanofi Winthrop Industrie
- 🇪🇺 CoAprovel Authorised · Sanofi Winthrop Industrie
- 🇪🇺 Irbesartan Hydrochlorothiazide BMS Withdrawn · Bristol-Myers Squibb Pharma EEIG
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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.