Dafiro HCT (amlodipine besilate;valsartan;hydrochlorothiazide)
- Region
- 🇪🇺 EU
- Active substance
- amlodipine besilate;valsartan;hydrochlorothiazide
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Hypertension
- EU approval
- Tue 03 Nov 2009
- Application
- EMEA/H/C/001160
- ATC
- C09DX01
- Official record
- www.ema.europa.eu
Indication
Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Exforge HCT Authorised · Novartis Europharm Limited
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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.