Bortezomib Hospira

Withdrawn

This medicine's authorisation has been withdrawn

bortezomib

Overview

On 7 August 2025, the European Commission withdrew the marketing authorisation for Bortezomib Hospira (bortezomib) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Pfizer Europe MA EEIG, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.

Bortezomib Hospira was granted marketing authorisation in the EU on 22 July 2016 for the treatment of multiple myeloma. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2021.

Bortezomib Hospira is a generic medicine of Velcade. There are other generic medicinal products of Velcade authorised and marketed in the EU. 

Bortezomib Hospira : EPAR - Summary for the public

Reference Number: EMA/CHMP/380101/2016

Bortezomib Hospira : EPAR - Risk-management-plan summary

Product information

Bortezomib Hospira : EPAR - Product Information

Bortezomib Hospira : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Bortezomib Hospira
• Active substance:
  bortezomib
• International non-proprietary name (INN) or common name:
  bortezomib
• Therapeutic area (MeSH):
  Multiple Myeloma
• Anatomical therapeutic chemical (ATC) code:
  L01XG01

Pharmacotherapeutic group

Other antineoplastic agents

Therapeutic indication

Bortezomib Hospira 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 Hospira 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 Hospira 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 Hospira 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.

Authorisation details

• EMA product number:
  EMEA/H/C/004207
• 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.

• Marketing authorisation holder:
  Pfizer Europe MA EEIG

  Boulevard de la Plaine 17; 1050 Bruxelles; Belgium

• Opinion adopted:
  26/05/2016
• Marketing authorisation issued:
  22/07/2016
• Withdrawal of marketing authorisation:
  07/08/2025
• Revision:
  14

Assessment history

Changes since initial authorisation of medicine

Bortezomib Hospira : EPAR - Procedural steps taken and scientific information after authorisation

Bortezomib Hospira : EPAR - Procedural steps taken and scientific information after authorisation (archive)

Bortezomib Hospira-H-C-PSUSA-00000424-202004 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/122201/2021

Bortezomib Hospira-H-C-PSUSA-00000424-201804 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/169116/2019

Initial marketing authorisation documents

Bortezomib Hospira : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/421198/2016

CHMP summary of opinion for Bortezomib Hospira

Adopted Reference Number: EMA/CHMP/327595/2016