Active substance
Sacubitril valsartan
- UK MHRA 8
- US price lines 3
- Safety 7
UK MHRA United Kingdom — marketing authorisations
| Product | Authorisation | Holder | Legal status |
|---|---|---|---|
| ENTRESTO 15 MG/16 MG GRANULES IN CAPSULES FOR OPENING | PLGB 00101/1226 | NOVARTIS PHARMACEUTICALS UK LIMITED | POM |
| ENTRESTO 24 MG/26 MG FILM COATED TABLETS | PLGB 00101/1041 | NOVARTIS PHARMACEUTICALS UK LIMITED | POM |
| ENTRESTO 49 MG/51 MG FILM COATED TABLETS | PLGB 00101/1042 | NOVARTIS PHARMACEUTICALS UK LIMITED | POM |
| ENTRESTO 6 MG/6 MG GRANULES IN CAPSULES FOR OPENING | PLGB 00101/1225 | NOVARTIS PHARMACEUTICALS UK LIMITED | POM |
| ENTRESTO 97 MG/103 MG FILM COATED TABLETS | PLGB 00101/1043 | NOVARTIS PHARMACEUTICALS UK LIMITED | POM |
| SACUBITRIL/VALSARTAN 24 MG/26 MG FILM-COATED TABLETS | PL 00101/1240 | NOVARTIS PHARMACEUTICALS UK LIMITED | POM |
| SACUBITRIL/VALSARTAN 49 MG/51 MG FILM-COATED TABLETS | PL 00101/1241 | NOVARTIS PHARMACEUTICALS UK LIMITED | POM |
| SACUBITRIL/VALSARTAN 97 MG/103 MG FILM-COATED TABLETS | PL 00101/1242 | NOVARTIS PHARMACEUTICALS UK LIMITED | POM |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | SACUBITRIL-VALSARTAN 24-26 MG | $0.49855 | per EA | 23 Sep 2026 |
| US NADAC | SACUBITRIL-VALSARTAN 49-51 MG | $0.53337 | per EA | 23 Sep 2026 |
| US NADAC | SACUBITRIL-VALSARTAN 97-103 MG | $0.59213 | per EA | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- EMA PRAC 31 Oct 2024 PRAC signal: Intestinal angioedema
Action for MAH: update of the product information: Yes - EMA PRAC 5 Sep 2024 PRAC signal: Myoclonus
Action for MAH: update of the product information: No - EMA PRAC 10 Mar 2022 PRAC signal: Vasoplegia syndrome
Action for MAH: update of the product information: No - EMA PRAC 28 Oct 2021 PRAC signal: Vasoplegia syndrome
Action for MAH: update of the product information: No - EMA PRAC 3 Sep 2020 PRAC signal: Psychosis and psychotic disorders
Action for MAH: update of the product information: No - EMA PRAC 16 Jan 2020 PRAC signal: Ventricular arrhythmia
Action for MAH: update of the product information: No - EMA PRAC 5 Sep 2019 PRAC signal: Ventricular arrhythmia
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.