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Zelboraf

240 milligram(s) Film-coated tablet

Roche Registration GmbHEU/1/12/751/001

Main Information

Trade NameZelboraf
Active Substances30% of r05185426 (vemurafenib)
Strength240 milligram(s)
Dosage FormFilm-coated tablet
Licence HolderRoche Registration GmbH
Licence NumberEU/1/12/751/001

Group Information

ATC CodeL01XE Protein kinase inhibitors
L01XE15 vemurafenib

Status

Authorised/WithdrawnAuthorised
Licence Issued
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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