Velcade

RSS

bortezomib

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 12/06/2020

Authorisation details

Product details
Name
Velcade
Agency product number
EMEA/H/C/000539
Active substance
bortezomib
International non-proprietary name (INN) or common name
bortezomib
Therapeutic area (MeSH)
Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
L01XX32
Publication details
Marketing-authorisation holder
Janssen-Cilag International NV
Revision
43
Date of issue of marketing authorisation valid throughout the European Union
26/04/2004
Contact address

Turnhoutseweg, 30
B-2340 Beerse
Belgium

Product information

13/02/2020 Velcade - EMEA/H/C/000539 - II/0093

Contents

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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

Changes since initial authorisation of medicine

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