Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Tabrecta 150 mg film-coated tablets.
Tabrecta 200 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Tabrecta 150 mg film-coated tablets: Pale orange brown, ovaloid, curved film-coated tablet with bevelled edges, unscored, debossed with “DU” on one side and “NVR” on the other side. Approximate size: 18.3 mm (length) x 7.3 mm (width). Tabrecta 200 mg film-coated tablets: Yellow, ovaloid, curved film-coated tablet with bevelled edges, unscored, debossed with “LO” on one side and “NVR” on the other side. Approximate size: 20.3 mm (length) x 8.1 mm (width). |
Tabrecta 150 mg film-coated tablets: Each film-coated tablet contains capmatinib dihydrochloride monohydrate equivalent to 150 mg capmatinib.
Tabrecta 200 mg film-coated tablets: Each film-coated tablet contains capmatinib dihydrochloride monohydrate equivalent to 200 mg capmatinib.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Capmatinib |
Capmatinib is an inhibitor of the MET receptor tyrosine kinase. Capmatinib inhibits MET phosphorylation (both autophosphorylation and phosphorylation triggered by the ligand hepatocyte growth factor [HGF]), MET-mediated phosphorylation of downstream signalling proteins, as well as proliferation and survival of MET-dependent cancer cells. |
| List of Excipients |
|---|
|
Tablet core: Cellulose microcrystalline Film-coating: Tabrecta 150 mg film-coated tablets: Hypromellose Tabrecta 200 mg film-coated tablets: Hypromellose |
PCTFE/PVC (polychlorotrifluoroethylene/polyvinyl chloride) blisters backed with an aluminium lidding foil.
Packs containing 60 or 120 film-coated tablets.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/22/1650/001-004
| Drug | Countries | |
|---|---|---|
| TABRECTA | Austria, Brazil, Canada, Spain, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Romania, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
