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
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. |
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. |
Below package inserts are available for further reading:
Title | Information Source | Document Type | |
---|---|---|---|
ENTRESTO Film-coated tablet | European Medicines Agency (EU) | MPI, EU: SmPC |
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 |
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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