Velcade

RSS

bortezomib

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

Overview

This is a summary of the European public assessment report (EPAR) for Velcade. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Velcade.

This EPAR was last updated on 28/03/2019

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
41
Date of issue of marketing authorisation valid throughout the European Union
26/04/2004
Contact address
Turnhoutseweg, 30
B-2340 Beerse
Belgium

Product information

20/02/2019 Velcade - EMEA/H/C/000539 - PSUSA/00000424/201804

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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