My HPRA: Register

GIOTRIF

40 Milligram Film Coated Tablet

Boehringer Ingelheim International GmbHEU/1/13/879/007-009

Main Information

Trade NameGIOTRIF
Active SubstancesAFATINIB-DIMALEATE
Strength40 Milligram
Dosage FormFilm Coated Tablet
Licence HolderBoehringer Ingelheim International GmbH
Licence NumberEU/1/13/879/007-009

Group Information

ATC CodeL01XE13 Protein kinase inhibitors

Status

Authorised/WithdrawnAuthorised
Licence Issued25/09/2013
Supply StatusSupply through pharmacies only
Dispensing StatusProduct subject to prescription which may not be renewed (A)
Marketing StatusMarketed
Promotion StatusPromotion 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).

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
« Back
Follow medicine

Print