Entresto

Medicinal product

(Invented) name

Entresto

Active substance (s)

Sakubitrilas/Valsartanas

Strength

6 mg/6 mg

Pharmaceutical form

granulės atidaromose kapsulėse

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C09DX04, Valsartan and sacubitril

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2015-11-19

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Granules in capsules for opening	1 vnt.
Sakubitrilas	6 mg
Valsartanas	6 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
111116	97227	1097227	lizdinė plokštelė	N60 (4 granulės)		Receptinis	EU/1/15/1058/023	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-11-19	Registruotas