Entresto (sacubitril;valsartan)
- Region
- 🇪🇺 EU
- Active substance
- sacubitril;valsartan
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Heart Failure
- CHMP opinion
- Thu 24 Sep 2015
- EU approval
- Thu 19 Nov 2015
- Application
- EMEA/H/C/004062
- ATC
- C09DX04
- Official record
- www.ema.europa.eu
Indication
Paediatric heart failure Entresto is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction. Adult heart failure Entresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Neparvis Authorised · Novartis Europharm Limited
Follow Entresto
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.