Dafiro (amlodipine;valsartan)
- Region
- 🇪🇺 EU
- Active substance
- amlodipine;valsartan
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Hypertension
- EU approval
- Mon 15 Jan 2007
- Application
- EMEA/H/C/000776
- ATC
- C09DB01
- Official record
- www.ema.europa.eu
Indication
Treatment of essential hypertension. Dafiro is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Amlodipine / Valsartan Mylan Authorised · Mylan Pharmaceuticals Limited
- 🇪🇺 Copalia HCT Authorised · Novartis Europharm Limited
- 🇪🇺 Copalia Authorised · Novartis Europharm Limited
- 🇪🇺 Exforge Authorised · Novartis Europharm Limited
- 🇪🇺 Imprida Withdrawn · Novartis Europharm Ltd
- 🇪🇺 Imprida HCT Lapsed · Novartis Europharm Ltd.
Follow Dafiro
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.