Bortezomib Fresenius Kabi

RSS

bortezomib

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

Overview

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

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

Bortezomib Fresenius Kabi 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 Fresenius Kabi is used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone.

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

This EPAR was last updated on 25/11/2019

Authorisation details

Product details
Name
Bortezomib Fresenius Kabi
Agency product number
EMEA/H/C/005074
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
Fresenius Kabi Deutschland GmbH
Date of issue of marketing authorisation valid throughout the European Union
14/11/2019
Contact address

Else-Kröner-Straße 1,
61352 Bad Homburg v.d.Höhe
Germany

Product information

14/11/2019 Bortezomib Fresenius Kabi - EMEA/H/C/005074 -

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Bortezomib 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 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 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 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

How useful was this page?

Add your rating