ENTRESTO

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, UK.

Active ingredients

The drug ENTRESTO contains a combination of these active pharmaceutical ingredients (APIs):

1
UNII 17ERJ0MKGI - SACUBITRIL
 

Sacubitril is a prodrug and its active metabolite, LBQ657, inhibits neprilysin (neutral endopeptidase; NEP). The complementary cardiovascular benefits in heart failure patients are attributed to the enhancement of peptides that are degraded by neprilysin, such as natriuretic peptides (NP), by LBQ657.

 
Read more about Sacubitril
2
UNII 80M03YXJ7I - VALSARTAN
 

Valsartan is an orally active, potent, and specific angiotensin II (Ang II) receptor antagonist. It acts selectively on the AT1-receptor subtype, which is responsible for the known actions of angiotensin II.

 
Read more about Valsartan

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 ENTRESTO Film-coated tablet MPI, EU: SmPC European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group Classification
C09DX04 Valsartan and sacubitril C Cardiovascular system → C09 Agents acting on the renin-angiotensin system → C09D Angiotensin II antagonists, combinations → C09DX Angiotensin II antagonists, other combinations
Discover more medicines within C09DX04

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
AU Pharmaceutical Benefits Scheme 11122J, 11123K, 11131W
BR Câmara de Regulação do Mercado de Medicamentos 526517080090401, 526517080090501, 526517080090601, 526517080090701, 526517080090801
CA Health Products and Food Branch 02446928, 02446936, 02446944
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 4960-MEE-0220, 4961-MEE-0220, 4962-MEE-0220
EE Ravimiamet 1704147, 1704158, 1704169, 1704170, 1704181, 1704192, 1736805, 1736816, 1736827, 1736838, 1736849, 1736850, 1736861, 1736872, 1736883, 1736894, 1771185
ES Centro de información online de medicamentos de la AEMPS 1151058001, 1151058003, 1151058006
FI Lääkealan turvallisuus- ja kehittämiskeskus 104675, 409547, 448897, 466739, 470817, 550845, 577135, 585287
FR Base de données publique des médicaments 61816438, 65122144, 65849001
GB Medicines & Healthcare Products Regulatory Agency 311365, 311369, 311378, 311381
HK Department of Health Drug Office 64630, 64631, 64632, 65170, 65171, 65172, 65318, 65319, 65320
IE Health Products Regulatory Authority 32412, 32413, 32414, 32415
IL מִשְׂרַד הַבְּרִיאוּת 7789, 7791, 7792
JP 医薬品医療機器総合機構 2190041F1027, 2190041F2023, 2190041F3020
LT Valstybinė vaistų kontrolės tarnyba 1079112, 1079113, 1079114, 1079115, 1079116, 1079117, 1079118, 1079858, 1079859, 1079860, 1079861, 1079862, 1079863, 1079864, 1079865, 1079866, 1084357, 1089047, 1089048, 1089049, 1089050, 1089051
NL Z-Index G-Standaard, PRK 132071, 132098, 132101
NZ Medicines and Medical Devices Safety Authority 18156, 18157, 18158
PL Rejestru Produktów Leczniczych 100309013, 100357087, 100357093
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W64479001, W64480001, W64481001
SG Health Sciences Authority 14947P, 14948P, 14949P
TN Direction de la Pharmacie et du Médicament 10283371, 10283372, 10283373
US FDA, National Drug Code 0078-0659, 0078-0696, 0078-0777
ZA Health Products Regulatory Authority 50/7.6/1016, 50/7.6/1017, 50/7.6/1018

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