Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Avastin   
Auth. number : EU/1/04/300
INN : bevacizumab
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: L01XC07 - Bevacizumab
(See WHO ATC Index)
Indication: Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.

Bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1.

Bevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Avastin in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1.

Bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.

Bevacizumab in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.

Bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Bevacizumab, in combination with carboplatin and gemcitabine, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents”.
Bevacizumab in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents.
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
14/01/2005 Centralised - Authorisation EMEA/H/C/582 (2005)97 of 12/01/2005
01/06/2005 Centralised - Variation EMEA/H/C/582/IA/1
10/11/2005 Centralised - Variation EMEA/H/C/582/IA/4
Updated with Decision(2005)6009 of 23/12/2005
03/01/2006 Centralised - Variation EMEA/H/C/582/II/3 (2005)6009 of 23/12/2005
03/02/2006 Centralised - Variation EMEA/H/C/582/II/2
27/03/2006 Centralised - Variation EMEA/H/C/582/II/5
07/06/2006 Centralised - Variation EMEA/H/C/582/II/6
06/07/2006 Centralised - Variation EMEA/H/C/582/II/7 (2006)3137 of 04/07/2006
25/01/2007 Centralised - Variation EMEA/H/C/582/IA/11
Updated with Decision(2007)1490 of 27/03/2007
29/01/2007 Centralised - Variation EMEA/H/C/582/II/10
29/03/2007 Centralised - Variation EMEA/H/C/582/II/8 (2007)1490 of 27/03/2007
25/04/2007 Centralised - Variation EMEA/H/C/582/II/13 (2007)1886 of 23/04/2007
30/05/2007 Centralised - Variation EMEA/H/C/582/IA/17
14/06/2007 Centralised - Variation EMEA/H/C/582/IB/18
26/06/2007 Centralised - Variation EMEA/H/C/582/II/12
23/08/2007 Centralised - Variation EMEA/H/C/582/II/9 (2007)4021 of 21/08/2007
26/10/2007 Centralised - Variation EMEA/H/C/582/II/16, 19 (2007)5298 of 24/10/2007
18/12/2007 Centralised - Variation EMEA/H/C/582/II/15 (2007)6674 of 14/12/2007
29/01/2008 Centralised - Variation EMEA/H/C/582/II/14 (2008)385 of 25/01/2008
28/02/2008 Centralised - Variation EMEA/H/C/582/II/20 (2008)820 of 26/02/2008
09/06/2008 Centralised - Variation EMEA/H/C/582/II/21
29/07/2008 Centralised - Variation EMEA/H/C/582/II/22
02/09/2008 Centralised - Variation EMEA/H/C/582/II/23 (2008)4768 of 29/08/2008
16/12/2008 Centralised - Variation EMEA/H/C/582/IA/27
27/03/2009 Centralised - Variation EMEA/H/C/582/II/25 (2009)2315 of 25/03/2009
08/04/2009 Centralised - Variation EMEA/H/C/582/N/29
Updated with Decision(2009)4355 of 29/05/2009
03/06/2009 Centralised - Variation EMEA/H/C/582/II/26 (2009)4355 of 29/05/2009
28/07/2009 Centralised - Variation EMEA/H/C/582/II/24, 30 (2009)5988 of 23/07/2009
31/07/2009 Centralised - Variation EMEA/H/C/582/IA/32
Updated with Decision(2009)10694 of 21/12/2009
23/12/2009 Centralised - Renewal EMEA/H/C/582/R/31 (2009)10694 of 21/12/2009
22/01/2010 Centralised - Variation EMEA/H/C/582/II/28 (2010)376 of 20/01/2010
07/06/2010 Centralised - Variation EMEA/H/C/582/II/34 (2010)3641 of 02/06/2010
08/07/2010 Centralised - Variation EMEA/H/C/582/II/35/G (2010)4812 of 06/07/2010
02/09/2010 Centralised - Variation EMEA/H/C/582/II/36 (2010)6094 of 31/08/2010
01/12/2010 Centralised - Variation EMEA/H/C/582/II/37 (2010)8540 of 26/11/2010
23/12/2010 Centralised - Variation EMEA/H/C/582/II/39 (2010)9651 of 20/12/2010
04/03/2011 Referral EMEA/H/C/582/A-20/38 (2011)1505 of 28/02/2011
29/03/2011 Centralised - Variation EMEA/H/C/582//II/40 (2011)2104 of 24/03/2011
04/07/2011 Centralised - Variation EMEA/H/C/582/II/33 (2011)4807 of 29/06/2011
02/08/2011 Centralised - Variation EMEA/H/C/582/II/43/G (2011)5610 of 27/07/2011
30/11/2011 Centralised - Variation EMEA/H/C/582/II/45 (2011)8862 of 24/11/2011
21/12/2011 Centralised - Variation EMEA/H/C/582/II/41, 42 (2011)9939 of 19/12/2011
09/02/2012 Centralised - Variation EMEA/H/C/582/II/48 (2012)819 of 06/02/2012
22/03/2012 Centralised - Variation EMEA/H/C/582/II/47/G (2012)1934 of 19/03/2012
02/07/2012 Centralised - Variation EMEA/H/C/582/II/51 (2012)4498 of 27/06/2012
04/09/2012 Centralised - Variation EMEA/H/C/582/II/44 (2012)6155 of 30/08/2012
26/10/2012 Centralised - Variation EMEA/H/C/582/II/46 (2012)7653 of 24/10/2012
16/11/2012 Centralised - Variation EMEA/H/C/582/II/53
Updated with Decision(2013)3226 of 27/05/2013
21/02/2013 Centralised - Variation EMEA/H/C/582/II/56/G
Updated with Decision(2013)3226 of 27/05/2013
21/02/2013 Centralised - Variation EMEA/H/C/582/II/57
Updated with Decision(2013)3226 of 27/05/2013
29/05/2013 Centralised - Variation EMEA/H/C/582/II/58/G (2013)3226 of 27/05/2013
02/07/2013 Centralised - Variation EMEA/H/C/582/IB/60
Updated with Decision(2014)4592 of 30/06/2014
19/09/2013 Centralised - Variation EMEA/H/C/582/II/61
Updated with Decision(2014)4592 of 30/06/2014
20/02/2014 Centralised - Variation EMEA/H/C/582/II/66
Updated with Decision(2014)4592 of 30/06/2014
25/04/2014 Centralised - Variation EMEA/H/C/582/II/65
Updated with Decision(2014)4592 of 30/06/2014
22/05/2014 Centralised - Refusal of marketing authorisation EMEA/H/C/582/II/59
22/05/2014 Centralised - Variation EMEA/H/C/582/II/64
Updated with Decision(2014)4592 of 30/06/2014
02/07/2014 Centralised - Variation (2014)4592 of 30/06/2014