Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Giotrif   
Auth. number : EU/1/13/879
Active substance : afatinib
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XE - Protein kinase inhibitors
Chemical substance: L01XE13 - Afatinib
(See WHO ATC Index)
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 (see section 5.1).
Marketing Authorisation Holder: Boehringer Ingelheim International GmbH
Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
27/09/2013 Centralised - Authorisation EMEA/H/C/2280 (2013)6342 of 25/09/2013
17/10/2014 Centralised - Notification EMEA/H/C/2280/N/6
Updated with Decision(2016)2026 of 31/03/2016
23/07/2015 Centralised - Variation EMEA/H/C/2280/II/9
Updated with Decision(2016)2026 of 31/03/2016
24/09/2015 Centralised - Variation EMEA/H/C/2280/II/13
Updated with Decision(2016)2026 of 31/03/2016
24/09/2015 Centralised - Variation EMEA/H/C/2280/II/14
Updated with Decision(2016)2026 of 31/03/2016
19/11/2015 Centralised - Variation EMEA/H/C/2280/II/15
Updated with Decision(2016)2026 of 31/03/2016
04/04/2016 Centralised - 2-Monthly update EMEA/H/C/2280/II/12 (2016)2026 of 31/03/2016
15/09/2016 Centralised - Variation EMEA/H/C/2280/II/0019
Updated with Decision(2016)7468 of 14/11/2016
10/11/2016 Centralised - Variation EMEA/H/C/002280/II/0020
16/11/2016 Centralised - 2-Monthly update EMEA/H/C/002280/II/0017 (2016)7468 of 14/11/2016
23/02/2017 Centralised - Variation EMEA/H/C/002280/II/0022
13/07/2017 Centralised - Variation EMEA/H/C/002280/II/0023