Bortezomib Accord
bortezomib
Table of contents
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.
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Bortezomib Accord : EPAR - Medicine overview (PDF/101.11 KB)
First published: 27/07/2015
Last updated: 14/06/2018
EMA/404258/2018 -
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Bortezomib Accord : EPAR - Risk-management-plan summary (PDF/69.94 KB)
First published: 27/07/2015
Last updated: 27/07/2015
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
|
Generic |
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 | |
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Marketing-authorisation holder |
Accord Healthcare S.L.U.
|
Revision |
13
|
Date of issue of marketing authorisation valid throughout the European Union |
20/07/2015
|
Contact address |
Accord Healthcare S.L.U. |
Product information
25/03/2022 Bortezomib Accord - EMEA/H/C/003984 - IB/0029
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
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.