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Tafinlar 50 mg hard capsules

50 milligram(s) Capsule, hard

Novartis Europharm LimitedEU/1/13/865/001-002

Main Information

Trade NameTafinlar 50 mg hard capsules
Active SubstancesDabrafenib
Strength50 milligram(s)
Dosage FormCapsule, hard
Licence HolderNovartis Europharm Limited
Licence NumberEU/1/13/865/001-002

Group Information

ATC CodeL01XE23 dabrafenib

Status

Authorised/WithdrawnAuthorised
Licence Issued26/08/2013
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 products on “restricted” medical prescription, reserved for use in certain specialised areas (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusMarketed

Documents

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