Velcade
bortezomib
Table of contents
Overview
Velcade is a cancer medicine that is generally used in combination with other medicines to treat multiple myeloma, a blood cancer, in:
- adults whose disease is getting worse after at least one other treatment and who have already had blood stem-cell transplantation or cannot have it. In these patients, Velcade is used either on its own or with pegylated liposomal doxorubicin or dexamethasone;
- previously untreated adults who cannot have high-dose chemotherapy with blood stem-cell transplantation. In these patients, Velcade is used in combination with melphalan and prednisone;
- previously untreated adults who are going to receive high-dose chemotherapy followed by a blood stem-cell transplantation. In these patients, Velcade is used in combination with dexamethasone, or with dexamethasone plus thalidomide.
Velcade is also used to treat mantle cell lymphoma, another blood cancer. It is used in adults who have not received any treatment for their cancer and who cannot have blood stem-cell transplantation. In these patients Velcade is used with rituximab, cyclophosphamide, doxorubicin and prednisone.
Velcade contains the active substance bortezomib.
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List item
Velcade : EPAR - Medicine overview (PDF/188.58 KB)
First published: 16/04/2009
Last updated: 12/06/2020
EMA/318389/2020 -
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List item
Velcade : EPAR - Risk-management-plan summary (PDF/72.77 KB)
First published: 08/04/2020
Authorisation details
Product details | |
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Name |
Velcade
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Agency product number |
EMEA/H/C/000539
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Active substance |
bortezomib
|
International non-proprietary name (INN) or common name |
bortezomib
|
Therapeutic area (MeSH) |
Multiple Myeloma
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Anatomical therapeutic chemical (ATC) code |
L01XG01
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Publication details | |
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Marketing-authorisation holder |
Janssen-Cilag International NV
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Revision |
45
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Date of issue of marketing authorisation valid throughout the European Union |
26/04/2004
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Contact address |
Turnhoutseweg, 30 |
Product information
13/05/2021 Velcade - EMEA/H/C/000539 - IA/0096
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Velcade 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.
Velcade 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.
Velcade 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.
Velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
Assessment history
News
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19/12/2014
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22/11/2013
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28/06/2013
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03/07/2012
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17/02/2012
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16/02/2012
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 January 201220/01/2012
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13/12/2011
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09/12/2011
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22/11/2011
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20/03/2008