Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Abraxane   
Auth. number : EU/1/07/428
Active substance : paclitaxel
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01C - Plant alkaloids and other natural products
Chemical subgroup: L01CD - Taxanes
Chemical substance: L01CD01 - Paclitaxel
(See WHO ATC Index)
Indication: Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated.
Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
Marketing Authorisation Holder: Celgene Europe Limited
1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, 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
15/01/2008 Centralised - Authorisation EMEA/H/C/778 (2008)159 of 11/01/2008
27/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/778/IA/1
27/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/778/IA/2
17/06/2008 Centralised - Variation EMEA/H/C/778/IA/4
Updated with Decision(2009)1018 of 10/02/2009
11/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/778/IA/6
02/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/778/IA/9
03/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/778/II/3
11/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/778/IB/10
13/02/2009 Centralised - Variation (2009)1018 of 10/02/2009
16/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/778/IA/11
06/04/2009 Centralised - Variation EMEA/H/C/778/II/8 (2009)2698 of 02/04/2009
25/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/778/II/15
31/07/2009 Centralised - Variation EMEA/H/C/778/II/12, 13 (2009)6190 of 29/07/2009
03/08/2009 Centralised - Variation EMEA/H/C/778/IB/16
Updated with Decision(2010)1824 of 15/03/2010
07/08/2009 Centralised - Variation EMEA/H/C/778/IA/17
Updated with Decision(2010)1824 of 15/03/2010
17/03/2010 Centralised - Variation (2010)1824 of 15/03/2010
23/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/778/IA/19
04/06/2010 Centralised - Variation EMEA/H/C/778/II/18 (2010)3650 of 02/06/2010
09/09/2010 Centralised - Variation EMEA/H/C/778/II/20 (2010)6250 of 06/09/2010
15/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/778/IA/21
22/03/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/778/T/22 (2011)1725 of 10/03/2011
11/05/2011 Centralised - Variation EMEA/H/C/778/IA/28
Updated with Decision(2011)4838 of 29/06/2011
12/05/2011 Centralised - Variation EMEA/H/C/778/IB/24
Updated with Decision(2011)4838 of 29/06/2011
05/07/2011 Centralised - Variation EMEA/H/C/778/II/23 (2011)4838 of 29/06/2011
24/04/2012 Centralised - Variation EMEA/H/C/778/II/34 (2012)2829 of 20/04/2012
02/07/2012 Centralised - Variation EMEA/H/C/778/II/37 (2012)4504 of 27/06/2012
30/07/2012 Centralised - Variation EMEA/H/C/778/IAin/43/G
Updated with Decision(2013)135 of 14/01/2013
16/11/2012 Centralised - Variation EMEA/H/C/778/II/44
Updated with Decision(2013)8834 of 03/12/2013
13/12/2012 Centralised - Variation EMEA/H/C/778/II/47
Updated with Decision(2013)8834 of 03/12/2013
16/01/2013 Centralised - Renewal EMEA/H/C/778/IAin/43/G, EMEA/H/C/778/R/39 (2013)135 of 14/01/2013
25/03/2013 Centralised - Variation EMEA/H/C/778/IAin/52/G
Updated with Decision(2013)8834 of 03/12/2013
25/07/2013 Centralised - Variation EMEA/H/C/778/II/56
Updated with Decision(2013)8834 of 03/12/2013
19/09/2013 Centralised - Variation EMEA/H/C/778/II/57/G
Updated with Decision(2013)8834 of 03/12/2013
06/12/2013 Centralised - Yearly update (2013)8834 of 03/12/2013
18/12/2013 Centralised - Variation EMEA/H/C/778/II/60
Updated with Decision(2014)8177 of 27/10/2014
30/12/2013 Centralised - 2-Monthly update EMEA/H/C/778/II/55 (2013)9835 of 20/12/2013
20/03/2014 Centralised - Variation EMEA/H/C/778/II/63
Updated with Decision(2014)8177 of 27/10/2014
29/10/2014 Centralised - 2-Monthly update EMEA/H/C/778/II/65 (2014)8177 of 27/10/2014
02/03/2015 Centralised - 2-Monthly update EMEA/H/C/778/II/67 (2015)1435 of 26/02/2015