Basic Information
Bortezomib Accord
Regulatory Information
EMEA/H/C/003984
July 20, 2015
May 21, 2015
15
April 1, 2025
Company Information
Spain
Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona
ACCORD HEALTHCARE SL
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
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.