Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Rhapsido 25 mg film-coated tablets.
| Pharmaceutical Form |
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Film-coated tablet (tablet). Light yellow, round, curved film-coated tablet with a diameter of 6.7 to 7.6 mm, debossed with "LV" on one side and with the company logo on the other side. |
Each film-coated tablet contains 25 mg remibrutinib.
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Remibrutinib is a selective Bruton's tyrosine kinase (BTK) inhibitor that forms a covalent bond with a cysteine residue in the BTK active site, leading to durable inactivation of BTK. The therapeutic effect of remibrutinib in CSU is achieved through inhibition of mast cell and basophil degranulation, including release of histamine and other proinflammatory mediators, mediated by pathogenic IgE or IgG directed against the FcεR1 or IgE. |
| List of Excipients |
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Tablet core: Mannitol Tablet coating: Polyvinyl alcohol |
Rhapsido is supplied in PA/alu/PVC/alu (polyamide/aluminium/polyvinylchloride/aluminium) blisters with aluminium foil backing and is available in packs containing 30, 60 or 180 film-coated tablets.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/26/2024/001-003
| Drug | Countries | |
|---|---|---|
| RHAPSIDO | United States |
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