Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: VELCADE   
Auth. number : EU/1/04/274
INN : bortezomib
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XX - Other antineoplastic agents
Chemical substance: L01XX32 - Bortezomib
(See WHO ATC Index)
Indication: As monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.
In combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high dose chemotherapy with haematopoietic stem cell transplantation.
In combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high dose chemotherapy with haematopoietic stem cell transplantation.
Marketing Authorisation Holder: Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België

  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
28/04/2004 Centralised - Authorisation EMEA/H/C/539 (2004)1721 of 26/04/2004
24/05/2004 Centralised - Variation EMEA/H/C/539/IA/2
24/05/2004 Centralised - Variation EMEA/H/C/539/IA/1
Updated with Decision(2004)3579 of 20/09/2004
23/09/2004 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/539/T/4 (2004)3579 of 20/09/2004
09/11/2004 Centralised - Variation EMEA/H/C/539/IB/6
Updated with Decision(2005)1293 of 20/04/2005
22/04/2005 Centralised - Variation EMEA/H/C/539/II/5 (2005)1293 of 20/04/2005
22/07/2005 Centralised - Variation EMEA/H/C/539/IA/13
29/07/2005 Centralised - Variation EMEA/H/C/539/II/7, 8 (2005)2968 of 27/07/2005
02/08/2005 Centralised - Variation EMEA/H/C/539/II/10
19/09/2005 Centralised - Variation EMEA/H/C/539/II/9
07/10/2005 Centralised - Variation EMEA/H/C/539/IB/12
21/10/2005 Centralised - Variation EMEA/H/C/539/II/14 (2005)4167 of 19/10/2005
23/01/2006 Centralised - Annual reassessment EMEA/H/C/539/S/11 (2006)129 of 19/01/2006
02/08/2006 Centralised - Variation EMEA/H/C/539/II/15 (2006)3534 of 28/07/2006
10/11/2006 Centralised - Variation EMEA/H/C/539/IA/17
30/11/2006 Centralised - Variation EMEA/H/C/539/IB/18
09/01/2007 Centralised - Annual reassessment EMEA/H/C/539/S/16 (2007)17 of 03/01/2007
29/03/2007 Centralised - Variation EMEA/H/C/539/IB/20
Updated with Decision(2007)3759 of 30/07/2007
01/08/2007 Centralised - Variation EMEA/H/C/539/II/19 (2007)3759 of 30/07/2007
26/09/2007 Centralised - Variation EMEA/H/C/539/II/21
18/12/2007 Centralised - Variation EMEA/H/C/539/II/25 (2007)6680 of 14/12/2007
14/01/2008 Centralised - Annual reassessment EMEA/H/C/539/S/22 (2008)68 of 10/01/2008
28/02/2008 Centralised - Variation EMEA/H/C/539/II/23
28/02/2008 Centralised - Variation EMEA/H/C/539/II/24
23/04/2008 Centralised - Variation EMEA/H/C/539/II/26, 27 (2008)1658 of 21/04/2008
31/07/2008 Centralised - Variation EMEA/H/C/539/II/29 (2008)4172 of 29/07/2008
02/09/2008 Centralised - Variation EMEA/H/C/539/II/28 (2008)4770 of 29/08/2008
06/11/2008 Centralised - Annual reassessment EMEA/H/C/539/S/30 (2008)6714 of 04/11/2008
17/11/2008 Centralised - Variation EMEA/H/C/539/N/31
Updated with Decision(2009)2608 of 31/03/2009
02/04/2009 Centralised - Renewal EMEA/H/C/539/II/32 (2009)2608 of 31/03/2009
03/06/2009 Centralised - Variation EMEA/H/C/539/II/34 (2009)4351 of 29/05/2009
30/06/2009 Centralised - Variation EMEA/H/C/539/II/33
21/09/2009 Centralised - Variation EMEA/H/C/539/IB/37
21/09/2009 Centralised - Variation EMEA/H/C/539/IB/38
30/10/2009 Centralised - Variation EMEA/H/C/539/II/36 (2009)8501 of 28/10/2009
02/12/2009 Centralised - Annual reassessment EMEA/H/C/539/S/35 (2009)9784 of 30/11/2009
29/04/2010 Centralised - Variation EMEA/H/C/539/II/39 (2010)2846 of 27/04/2010
19/05/2010 Centralised - Variation EMEA/H/C/539/IB/42
Updated with Decision(2010)4718 of 02/07/2010
04/06/2010 Centralised - Variation EMEA/H/C/539/II/40 (2010)3643 of 02/06/2010
22/06/2010 Centralised - Variation EMEA/H/C/539/IA/44
06/07/2010 Centralised - Variation EMEA/H/C/539/II/41 (2010)4718 of 02/07/2010
15/12/2010 Centralised - Annual reassessment EMEA/H/C/539/S/45 (2010)9289 of 13/12/2010
05/07/2011 Centralised - Variation EMEA/H/C/539/II/46 (2011)4840 of 29/06/2011
30/08/2011 Centralised - Variation EMEA/H/C/539/II/50 (2011)6165 of 24/08/2011
28/11/2011 Referral EMEA/H/C/539/A-20 (2011)8864 of 24/11/2011
22/03/2012 Centralised - Annual reassessment EMEA/H/C/539/S/52, EMEA/H/C/539/II/53 (2012)1936 of 19/03/2012
26/03/2012 Centralised - Variation EMEA/H/C/539/II/54 (2012)2029 of 21/03/2012
31/05/2012 Referral EMEA/H/C/539/A-20/56 (2012)3595 of 25/05/2012
21/10/2012 Centralised - Variation EMEA/H/C/539/X/47 (2012)6706 of 20/09/2012
24/10/2012 Centralised - Variation EMEA/H/C/539/X/47 (2012)6707 of 20/09/2012
21/03/2013 Centralised - Variation EMEA/H/C/539/II/61
Updated with Decision(2013)5154 of 31/07/2013
27/06/2013 Centralised - Variation EMEA/H/C/539/II/62
Updated with Decision(2013)5154 of 31/07/2013
05/08/2013 Centralised - Variation EMEA/H/C/539/II/59 (2013)5154 of 31/07/2013
23/12/2013 Centralised - Variation EMEA/H/C/539/II/63/G (2013)9756 of 18/12/2013
14/01/2014 Centralised - Renewal EMEA/H/C/539/R/66 (2014)138 of 10/01/2014
18/03/2014 Centralised - Variation EMEA/H/C/539/N/71