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Tabrecta



Novartis Europharm LimitedEU/1/22/1650/001-002

Main Information

Trade NameTabrecta
Active SubstancesCapmatinib dihydrochloride monohydrate
Dosage FormFilm-coated tablet
Licence HolderNovartis Europharm Limited
Licence NumberEU/1/22/1650/001-002

Group Information

ATC CodeL01 ANTINEOPLASTIC AGENTS
L01EX17 Capmatinib dihydrochloride monohydrate

Status

License statusAuthorised
Licence Issued20/06/2022
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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