sacubitril/valsartan
Entresto, Neparvis · ATC code C09DX04
Also known as: Sacubitril / Valsartan · Brand names: Entresto, Neparvis, Sabivalsax, Sacubitril/Valsartan Devatis, Sacubitril/Valsartan Ratiopharm, Sacubitril/Valsartan Stada, Sacubitril/Valsartan Tad, Sacubitril/Valsartan Accord, Sacubitril/Valsartan Al, Sacubitril/Valsartan Beta, Fradine, Neprilex, Oneptus, Ovefran
- Key facts
- Active substance
- sacubitril/valsartan (INN: sacubitril / valsartan)
- ATC code
- C09DX04
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Entresto 24 mg/26 mg film-coated tablets / Entresto 49 mg/51 mg film-coated tablets / Entresto 97 mg/103 mg film-coated tablets · Entresto 6 mg/6 mg granules in capsules for opening / Entresto 15 mg/16 mg granules in capsules for opening · Neparvis 24 mg/26 mg film-coated tablets / Neparvis 49 mg/51 mg film-coated tablets / Neparvis 97 mg/103 mg film-coated tablets · Neparvis 6 mg/6 mg granules in capsules for opening / Neparvis 15 mg/16 mg granules in capsules for opening
- Marketing authorisation holder
- Novartis Europharm Limited
- Information as of
- 2026-10-27
Key facts
Sacubitril/valsartan (Entresto) combines a neprilysin inhibitor with an angiotensin II receptor blocker. It is used for symptomatic chronic heart failure in adults and children.
What it is used for
- Adults: symptomatic chronic heart failure with reduced ejection fraction
- Children and adolescents aged one year or older: symptomatic chronic heart failure with left ventricular systolic dysfunction
Dosing
- Adults (film-coated tablets): start 49 mg/51 mg twice daily, doubled at 2-4 weeks to the target dose of 97 mg/103 mg twice daily
- Not on, or on low-dose, ACE inhibitor/ARB, or SBP 100 to 110 mmHg: start 24 mg/26 mg twice daily with slow titration
- Children: weight-based dosing; granules for children under 40 kg
- Moderate renal impairment: consider half the starting dose; severe renal impairment and moderate hepatic impairment: half the starting dose
- Do not start if potassium >5.4 mmol/l or SBP <100 mmHg; not until 36 hours after the last ACE inhibitor dose
Contraindications
- Hypersensitivity to the active substances or excipients
- Concomitant ACE inhibitors
- History of angioedema with prior ACE inhibitor or ARB; hereditary or idiopathic angioedema
- Aliskiren in diabetes mellitus or eGFR <60 ml/min/1.73 m²
- Severe hepatic impairment, biliary cirrhosis, cholestasis
- Second and third trimesters of pregnancy
Important warnings
- Dual RAAS blockade: do not combine with ACE inhibitors or other ARBs; aliskiren not recommended
- Hypotension; adjust concomitant drugs or down-titrate if not tolerated
- Hyperkalaemia and renal function deterioration
- Angioedema
Side effects
- Most common in adults: hypotension (17.6%), hyperkalaemia (11.6%), renal impairment (10.1%)
- Angioedema in 0.5% of patients
- Common: anaemia, hypokalaemia, dizziness, headache, syncope, vertigo, orthostatic hypotension
Interactions
- ACE inhibitors: contraindicated due to angioedema risk; 36 hours apart when switching either way
- Aliskiren and other ARBs: avoid dual RAAS blockade
Pregnancy and breastfeeding
- Not recommended in the first trimester; contraindicated in the second and third trimesters
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- EntrestoNovartis Europharm Limited · EMEA/H/C/004062
- NeparvisNovartis Europharm Limited · EMEA/H/C/004343
Source: European Medicines Agency (EMA), product information
Austria
- SabivalsaxG.L. Pharma Gmbh · 1 register entry
- Sacubitril/Valsartan DevatisDevatis Gmbh · 1 register entry
- Sacubitril/Valsartan RatiopharmRatiopharm Arzneimittel Vertriebs-Gmbh · 1 register entry
- Sacubitril/Valsartan StadaStada Arzneimittel Gmbh · 1 register entry
- Sacubitril/Valsartan TadTad Pharma Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- Sacubitril/Valsartan AccordAccord Healthcare B.V. · 1 register entry
- Sacubitril/Valsartan AlAliud Pharma Gmbh · 1 register entry
- Sacubitril/Valsartan BetaBetapharm Arzneimittel Gmbh · 1 register entry
- Sacubitril/Valsartan DevatisDevatis Gmbh · 1 register entry
- Sacubitril/Valsartan StadaStadapharm Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- FradineSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
- NeprilexALİ RAİF İLAÇ SAN. A.Ş. · 3 register entries
- OneptusFARMANOVA SAĞLIK HİZMETLERİ LTD. ŞTİ. · 3 register entries
- OvefranSABA İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 28 more European countries
- Belgium
- Sacubitril/Valsartan Eg, Sacubitril/Valsartan Hcs, Sacubitril/Valsartan Teva
- Bulgaria
- Sabivalsax, Атрилесто, Валкубит, Сакубитрил/Валсартан Гедеон Рихтер, Сакубитрил/Валсартан Полфарма, Санпла
- Croatia
- Atrilesto, Culbista, Sakubitril/Valsartan Accord, Sakubitril/Valsartan Galenika, Sanpla, Valkubit
- Cyprus
- Sacubitril+valsartan Hemopharm, Sacubitril/Valsartan Accord, Sacubitril/Valsartan Tad
- Czechia
- Sacubitril/Valsartan Accord, Sakubitril/Valsartan Teva, Sanpla, Savatil, Valkubit
- Denmark
- Bitrisal, Lumivaxon, Sacubitril+valsartan Axunio, Sacubitril/Valsartan Accord, Sacubitril/Valsartan Axunio, Sacubitril/Valsartan Devatis, Sacubitril/Valsartan Krka, Sacubitril/Valsartan Teva
- Estonia
- Culbista, Sacubitril/Valsartan Accord, Sacubitril/Valsartan Gedeon Richter, Sacubitril/Valsartan Teva, Valkubit
- Finland
- Lumivaxon, Sacubitril/Valsartan Accord, Sacubitril/Valsartan Axunio, Sacubitril/Valsartan Devatis, Sacubitril/Valsartan Krka, Sacubitril/Valsartan Ratiopharm, Sacubitril/Valsartan Stada
- France
- Sacubitril / Valsartan Biogaran, Sacubitril/Valsartan Accord, Sacubitril/Valsartan Axunio, Sacubitril/Valsartan Eg, Sacubitril/Valsartan Hcs, Sacubitril/Valsartan Teva, Sacubitril/Valsartan Vale
- Greece
- Bitrisal, Ensavalia, Sacubitril+valsartan Stada, Sanpla, Vacubio, Valkubit
- Hungary
- Albaliva, Sacubitril/Valsartan Gedeon Richter, Sacubitril/Valsartan Stada, Sacubitril/Valsartan Teva, Valkubit
- Iceland
- Entresto, Neparvis, Sacubitril/Valsartan Krka, Sacubitril/Valsartan Wh
- Ireland
- Sacubitril/Valsartan Accord, Sacubitril/Valsartan Krka, Sacubitril/Valsartan Teva
- Italy
- Sacubitril E Valsartan Accord, Sacubitril E Valsartan Alter, Sacubitril E Valsartan Axunio, Sacubitril E Valsartan Doc Generici, Sacubitril E Valsartan Eg, Sacubitril E Valsartan Krka, Sacubitril E Valsartan Pensa, Sacubitril E Valsartan Teva, Sacubitril/Valsartan Doc
- Latvia
- Culbista, Sacubitril/Valsartan Gedeon Richter, Sacubitril/Valsartan Polpharma, Sacubitril/Valsartan Teva, Valkubit
- Liechtenstein
- Entresto, Neparvis
- Lithuania
- Culbista, Sacubitril/Valsartan Polpharma, Sacubitril/Valsartan Teva, Valkubit
- Luxembourg
- Sacubitril/Valsartan Eg
- Malta
- Sacubitril/Valsartan Axunio, Sacubitril/Valsartan Clonmel, Sacubitril/Valsartan Genthon, Sacubitril/Valsartan Synthon, Valkubit
- Netherlands
- Atrilesto, Brazier, Culbista, Ensavalia, Lumivaxon, Orivantara, Oximera, Sabivalsax, Sacubitril/Valsartan Accord, Sacubitril/Valsartan Aet, Sacubitril/Valsartan Axunio, Sacubitril/Valsartan Cf, Sacubitril/Valsartan Devatis, Sacubitril/Valsartan Doc, Sacubitril/Valsartan Farmaprojects, Sacubitril/Valsartan Genericon, Sacubitril/Valsartan Genthon, Sacubitril/Valsartan Pluspharma, Sacubitril/Valsartan Stada Arzneimittel Ag, Sacubitril/Valsartan Synthon, Sacubitril/Valsartan Teva, Sacubitril/Valsartan Tiefenbacher, Sacubitril/Valsartan Tifi, Sacubitril/Valsartan Uni-Pharma, Sacubitril/Valsartan Vale
- Norway
- Entresto, Neparvis, Sacubitril+valsartan Axunio, Sacubitril/Valsartan Accord, Sacubitril/Valsartan Axunio, Sacubitril/Valsartan Krka, Sacubitril/Valsartan Stada, Sacubitril/Valsartan Teva, Sacubitril/Valsartan Vale, Sakubitril/Valsartan Devatis
- Poland
- Albaliva, Brazier, Culbista, Sacubitril/Valsartan Gedeon Richter, Sartesta, Valkubit
- Portugal
- Arentri, Bidcor, Neprilin, Sacubitril + Valsartan
- Romania
- Sacubitril/Valsartan Dr. Reddy’s, Sacubitril/Valsartan Gedeon Richter, Sacubitril/Valsartan Teva, Valkubit
- Slovakia
- Sacubitril/Valsartan Gedeon Richter, Sacubitril/Valsartan Polpharma, Sacubitril/Valsartan Stada, Sacubitril/Valsartan Teva, Valkubit
- Slovenia
- Sakubitril/Valsartan Galenika, Sakubitril/Valsartan Hcs, Sakubitril/Valsartan Krka, Sakubitril/Valsartan Stada, Sanpla, Valkubit
- Spain
- Bidcor, Sacubitrilo / Valsartán Cinfamed, Sacubitrilo/Valsartan Axunio, Sacubitrilo/Valsartán Alter, Sacubitrilo/Valsartán Gobens, Sacubitrilo/Valsartán Kern Pharma, Sacubitrilo/Valsartán Normon, Sacubitrilo/Valsartán Pensa, Sacubitrilo/Valsartán Synthon, Sacubitrilo/Valsartán Teva
- Sweden
- Sacubitril/Valsartan Accord, Sacubitril/Valsartan Axunio, Sacubitril/Valsartan Krka, Sacubitril/Valsartan Reddy, Sacubitril/Valsartan Stada, Sacubitril/Valsartan Teva, Sakubitril/Valsartan Devatis, Sanpla
EMA – Article 57 product data (EU/EEA), 2026-10-28
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Sources
- European Medicines Agency. Entresto – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/entresto-epar-product-information_en.pdf
- European Medicines Agency. Neparvis – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/neparvis-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.