Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Tarceva   
Auth. number : EU/1/05/311
Active substance : Erlotinib
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XE - Protein kinase inhibitors
Chemical substance: L01XE03 - Erlotinib
(See WHO ATC Index)
Indication: Non-Small Cell Lung Cancer (NSCLC):
Tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations.

Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations and stable disease after first-line chemotherapy.

Tarceva is also indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.

When prescribing Tarceva, factors associated with prolonged survival should be taken into account.

No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC negative tumours.

Pancreatic cancer:
Tarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer.

When prescribing Tarceva, factors associated with prolonged survival should be taken into account.

No survival advantage could be shown for patients with locally advanced disease.
Marketing Authorisation Holder: Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom
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
21/09/2005 Centralised - Authorisation EMEA/H/C/618 (2005)3618 of 19/09/2005
11/10/2005 Centralised - Variation EMEA/H/C/618/IA/1
Updated with Decision(2006)1045 of 22/03/2006
24/03/2006 Centralised - Variation EMEA/H/C/618/II/3 (2006)1045 of 22/03/2006
06/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/618/IB/4
21/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/618/II/5
24/11/2006 Centralised - Variation EMEA/H/C/618/II/6 (2006)5729 of 22/11/2006
01/12/2006 Centralised - Variation EMEA/H/C/618/IA/9
Updated with Decision(2006)261 of 24/01/2007
26/01/2007 Centralised - Variation EMEA/H/C/618/II/2 (2006)261 of 24/01/2007
01/03/2007 Centralised - Variation EMEA/H/C/618/II/7, 7 (2007)710 of 27/02/2007
26/07/2007 Centralised - Variation EMEA/H/C/618/II/10 (2007)3654 of 24/07/2007
21/09/2007 Centralised - Variation EMEA/H/C/618/IA/11
Updated with Decision(2008)309 of 18/01/2008
22/01/2008 Centralised - Variation EMEA/H/C/618/II/12 (2008)309 of 18/01/2008
04/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/618/IA/13
17/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/618/IA/15
29/01/2009 Centralised - Variation EMEA/H/C/618/II/14 (2009)587 of 27/01/2009
01/06/2009 Centralised - Variation EMEA/H/C/618/II/16 (2009)4325 of 28/05/2009
29/04/2010 Centralised - Variation EMEA/H/C/618/II/17 (2010)2840 of 27/04/2010
05/07/2010 Centralised - Variation EMEA/H/C/618/II/19/G (2010)4663 of 01/07/2010
07/07/2010 Centralised - Renewal EMEA/H/C/618/R/18 (2010)4713 of 02/07/2010
10/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/618/IA/22
12/08/2010 Centralised - Variation EMEA/H/C/618/IB/21
Updated with Decision(2011)1647 of 08/03/2011
25/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/618/IA/25
03/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/618/IB/24/G
10/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/618/IB/23/G
10/03/2011 Centralised - Variation (2011)1647 of 08/03/2011
20/05/2011 Centralised - Variation EMEA/H/C/618/II/26 (2011)3600 of 18/05/2011
26/08/2011 Centralised - Variation EMEA/H/C/618/II/20 (2011)6126 of 24/08/2011
25/06/2012 Centralised - Variation EMEA/H/C/618/II/27 (2012)4352 of 21/06/2012
27/09/2012 Centralised - Variation EMEA/H/C/618/IAin/28/G
Updated with Decision(2012)7861 of 29/10/2012
31/10/2012 Centralised - Variation (2012)7861 of 29/10/2012
21/02/2013 Centralised - Variation EMEA/H/C/618/II/31
Updated with Decision(2013)5607 of 26/08/2013
29/08/2013 PSUSA - Modification EMEA/H/C/618/PSU/20 (2013)5607 of 26/08/2013
24/10/2013 Centralised - Variation EMEA/H/C/618/II/32
Updated with Decision(2014)7478 of 08/10/2014
18/12/2013 Centralised - Variation EMEA/H/C/618/II/33
Updated with Decision(2014)7478 of 08/10/2014
10/10/2014 Centralised - Yearly update (2014)7478 of 08/10/2014
27/01/2016 Centralised - 2-Monthly update EMEA/H/C/618/II/43 (2016)458 of 25/01/2016