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Neparvis (sacubitril;valsartan)

Region
🇪🇺 EU
Active substance
sacubitril;valsartan
Company
Novartis Europharm Limited
Status
Authorised
Therapeutic area
Heart Failure
CHMP opinion
Thu 31 Mar 2016
EU approval
Thu 26 May 2016
Application
EMEA/H/C/004343
ATC
C09DX04
Official record
www.ema.europa.eu

Indication

Paediatric heart failure Neparvis is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction (see section 5.1). Adult heart failure Neparvis is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction (see section 5.1).

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

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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.