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Tarceva



Roche Registration GmbHEU/1/05/311/01-3

Main Information

Trade NameTarceva
Active SubstancesERLOTINIB HYDROCHLORIDE
Dosage FormFilm-coated tablet
Licence HolderRoche Registration GmbH
Licence NumberEU/1/05/311/01-3

Group Information

ATC CodeL01EB02 erlotinib

Status

License statusAuthorised
Licence Issued19/09/2005
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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