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.
Giotrif : EPAR - Summary for the public (PDF/80.92 KB)
First published: 16/10/2013
Last updated: 24/05/2016
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Carcinoma, Non-Small-Cell Lung
|Anatomical therapeutic chemical (ATC) code||
Boehringer Ingelheim International GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
Binger Strasse 173
06/04/2021 Giotrif - EMEA/H/C/002280 - N/0037
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.