Giotrif

RSS

afatinib

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Giotrif. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Giotrif.

For practical information about using Giotrif, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 26/07/2018

Authorisation details

Product details
Name
Giotrif
Agency product number
EMEA/H/C/002280
Active substance
afatinib
International non-proprietary name (INN) or common name
afatinib
Therapeutic area (MeSH)
Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
L01XE13
Publication details
Marketing-authorisation holder
Boehringer Ingelheim International GmbH
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
24/09/2013
Contact address
Binger Strasse 173
55216 Ingelheim
Germany

Product information

28/06/2018 Giotrif - EMEA/H/C/002280 - II/0028

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Giotrif as monotherapy is indicated for the treatment of

  • Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s);
  • locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.

Assessment history

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