Bortezomib Accord

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bortezomib

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

Overview

Bortezomib Accord is a cancer medicine used to treat multiple myeloma, a blood cancer, in the following groups of patients:

  • adults whose disease is getting worse after at least one other treatment and who have already had, or cannot have, blood stem-cell transplantation. In these patients, Bortezomib Accord is used either on its own or in combination with pegylated liposomal doxorubicin or dexamethasone;
  • previously untreated adults who cannot have high-dose chemotherapy with blood stem-cell transplantation. In these patients, Bortezomib Accord is used in combination with melphalan and prednisone;
  • previously untreated adults who are going to receive high-dose chemotherapy followed by blood stem-cell transplantation. In this group of patients, Bortezomib Accord is used in combination with dexamethasone, or with dexamethasone plus thalidomide.

Bortezomib Accord is also used to treat mantle cell lymphoma, another blood cancer, in untreated adults who cannot have blood stem-cell transplantation. For mantle cell lymphoma, Bortezomib Accord is used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone.

Bortezomib Accord contains the active substance bortezomib.

Bortezomib Accord is a ‘generic medicine’. This means that Bortezomib Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Velcade.

This EPAR was last updated on 10/04/2019

Authorisation details

Product details
Name
Bortezomib Accord
Agency product number
EMEA/H/C/003984
Active substance
bortezomib
International non-proprietary name (INN) or common name
bortezomib
Therapeutic area (MeSH)
Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
L01XX32
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
20/07/2015
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

25/03/2019 Bortezomib Accord - EMEA/H/C/003984 - IB/0018

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Bortezomib Accord 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.

Bortezomib Accord 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.

Bortezomib Accord 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.

Bortezomib Accord 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

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