Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Vectibix   
Auth. number : EU/1/07/423
INN : panitumumab
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XC - Monoclonal antibodies
Chemical substance: L01XC08 - Panitumumab
(See WHO ATC Index)
Indication: Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC):
• in first-line in combination with FOLFOX.
• in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).
• as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
Marketing Authorisation Holder: Amgen Europe B.V.
Minervum 7061, NL-4817 ZK Breda, Nederland

  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
05/12/2007 Centralised - Authorisation EMEA/H/C/741 (2007)6115 of 03/12/2007
30/04/2008 Centralised - Variation EMEA/H/C/741/II/1
18/06/2008 Centralised - Variation EMEA/H/C/741/IB/5
Updated with Decision(2008)4409 of 08/08/2008
15/07/2008 Centralised - Variation EMEA/H/C/741/II/3
29/07/2008 Centralised - Variation EMEA/H/C/741/II/2
12/08/2008 Centralised - Variation EMEA/H/C/741/II/4 (2008)4409 of 08/08/2008
28/10/2008 Centralised - Variation EMEA/H/C/741/II/6 (2008)6368 of 24/10/2008
28/11/2008 Centralised - Variation EMEA/H/C/741/II/7
24/12/2008 Centralised - Variation EMEA/H/C/741/II/8 (2008)8974 of 22/12/2008
23/03/2009 Centralised - Annual renewal EMEA/H/C/741/RA/9 (2009)2125 of 19/03/2009
09/04/2009 Centralised - Variation EMEA/H/C/741/II/10 (2009)0897 of 07/04/2009
01/07/2009 Centralised - Variation EMEA/H/C/741/II/11
05/10/2009 Centralised - Variation EMEA/H/C/741/II/13
03/11/2009 Centralised - Variation EMEA/H/C/741/II/14
09/02/2010 Centralised - Variation EMEA/H/C/741/II/15
17/03/2010 Centralised - Annual renewal EMEA/H/C/741/R/12 (2010)1800 of 15/03/2010
03/05/2010 Centralised - Variation EMEA/H/C/741/II/16 (2010)2932 of 29/04/2010
01/09/2010 Centralised - Variation EMEA/H/C/741/IA/19/G
Updated with Decision(2010)9286 of 13/12/2010
24/11/2010 Centralised - Variation EMEA/H/C/741/IA/20/G
14/12/2010 Centralised - Variation EMEA/H/C/741/IA/23/G
Updated with Decision(2011)3717 of 23/05/2011
15/12/2010 Centralised - Annual renewal EMEA/H/C/741/R/18 (2010)9286 of 13/12/2010
01/02/2011 Centralised - Variation EMEA/H/C/741/IB/21
01/02/2011 Centralised - Variation EMEA/H/C/741/IB/22
27/04/2011 Centralised - Variation EMEA/H/C/741/II/24/G
26/05/2011 Centralised - Variation EMEA/H/C/741/II/25 (2011)3717 of 23/05/2011
26/05/2011 Centralised - Variation EMEA/H/C/741/IA/29/G
15/06/2011 Centralised - Variation EMEA/H/C/741/IA/30/G
Updated with Decision(2011)8239 of 10/11/2011
14/11/2011 Centralised - Variation EMEA/H/C/741/II/17 (2011)8240 of 10/11/2011
15/11/2011 Centralised - Variation EMEA/H/C/741/II/17 (2011)8239 of 10/11/2011
24/01/2012 Centralised - Variation EMEA/H/C/741/II/32 (2012)416 of 20/01/2012
22/02/2012 Centralised - Annual renewal EMEA/H/C/741/R/34 (2012)1189 of 17/02/2012
29/06/2012 Centralised - Variation EMEA/H/C/741/II/37, 38 (2012)4519 of 27/06/2012
15/08/2012 Centralised - Variation EMEA/H/C/741/IAin/42
Updated with Decision(2012)7716 of 25/10/2012
27/08/2012 Centralised - Variation EMEA/H/C/741/II/39/G (2012)5995 of 23/08/2012
29/10/2012 Centralised - Variation (2012)7716 of 25/10/2012
17/01/2013 Centralised - Annual renewal EMEA/H/C/741/R/43 (2013)139 of 14/01/2013
29/07/2013 Centralised - Variation EMEA/H/C/741/II/50 (2013)4945 of 25/07/2013
25/02/2014 Centralised - Annual renewal EMEA/H/C/741/R/54 (2014)1311 of 21/02/2014
25/04/2014 Centralised - Variation EMEA/H/C/741/II/56
27/05/2014 Centralised - Variation EMEA/H/C/741/N/61