ENTRESTO

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

Active ingredients

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

1 Sacubitril
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 about Sacubitril
2 Valsartan
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 about Valsartan

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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

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