Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Entresto 24 mg/26 mg film-coated tablets.
Entresto 49 mg/51 mg film-coated tablets.
Entresto 97 mg/103 mg film-coated tablets.
| Pharmaceutical Form |
|---|
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Film-coated tablet (tablet). Entresto 24 mg/26 mg film-coated tablets: Violet white ovaloid biconvex film-coated tablet with bevelled edges, unscored, debossed with “NVR” on one side and “LZ” on the other side. Approximate tablet dimensions 13.1 mm x 5.2 mm. Entresto 49 mg/51 mg film-coated tablets: Pale yellow ovaloid biconvex film-coated tablet with bevelled edges, unscored, debossed with “NVR” on one side and “L1” on the other side. Approximate tablet dimensions 13.1 mm x 5.2 mm. Entresto 97 mg/103 mg film-coated tablets: Light pink ovaloid biconvex film-coated tablet with bevelled edges, unscored, debossed with “NVR” on one side and “L11” on the other side. Approximate tablet dimensions 15.1 mm x 6.0 mm. |
Entresto 24 mg/26 mg film-coated tablets: Each film-coated tablet contains 24.3 mg sacubitril and 25.7 mg valsartan (as sacubitril valsartan sodium salt complex).
Entresto 49 mg/51 mg film-coated tablets: Each film-coated tablet contains 48.6 mg sacubitril and 51.4 mg valsartan (as sacubitril valsartan sodium salt complex).
Entresto 97 mg/103 mg film-coated tablets: Each film-coated tablet contains 97.2 mg sacubitril and 102.8 mg valsartan (as sacubitril valsartan sodium salt complex).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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. |
|
| 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. |
|
| Valsartan and Sacubitril |
|
| List of Excipients |
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Tablet core: Microcrystalline cellulose Film coat: Entresto 24 mg/26 mg film-coated tablets: Hypromellose, substitution type 2910 (3 mPa·s) Entresto 49 mg/51 mg film-coated tablets: Hypromellose, substitution type 2910 (3 mPa·s) Entresto 97 mg/103 mg film-coated tablets: Hypromellose, substitution type 2910 (3 mPa·s) |
PVC/PVDC/Aluminium blisters.
Entresto 24 mg/26 mg film-coated tablets:
Pack sizes: 14, 20, 28, 56 or 196 film-coated tablets and multipacks containing 196 (7 packs of 28) film-coated tablets.
Entresto 49 mg/51 mg film-coated tablets:
Pack sizes: 14, 20, 28, 56, 168 or 196 film-coated tablets and multipacks containing 168 (3 packs of 56) or 196 (7 packs of 28) film-coated tablets.
Entresto 97 mg/103 mg film-coated tablets:
Pack sizes: 14, 20, 28, 56, 168 or 196 film-coated tablets and multipacks containing 168 (3 packs of 56) or 196 (7 packs of 28) film-coated tablets.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Entresto 24 mg/26 mg film-coated tablets:
EU/1/15/1058/001
EU/1/15/1058/008-010
EU/1/15/1058/017-018
Entresto 49 mg/51 mg film-coated tablets:
EU/1/15/1058/002-004
EU/1/15/1058/011-013
EU/1/15/1058/019-020
Entresto 97 mg/103 mg film-coated tablets:
EU/1/15/1058/005-007
EU/1/15/1058/014-016
EU/1/15/1058/021-022
Date of first authorisation: 19 November 2015
Date of latest renewal: 25 June 2020
| Drug | Countries | |
|---|---|---|
| ENTRESTO | 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 |
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