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.
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.
Therapeutic Area (MeSH)
ATC Code
L01XG01
ATC Item
N/A
Pharmacotherapeutic Group
Other antineoplastic agents
Active Substance (Summary)
INN / Common Names
EMA Name
Bortezomib Hospira
Medicine Name
Bortezomib Hospira
Aliases
N/ANo risk management plan link.
