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BORTEZOMIB MEDICIANZ (Medsurge Pharma Pty Ltd)

Product name
BORTEZOMIB MEDICIANZ
Sponsor
Medsurge Pharma Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
114 (255 working days)
Active ingredients
Bortezomib
Registration type
New generic medicine
Indication

TRADE NAME, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.

TRADE NAME, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.

TRADE NAME is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.

TRADE NAME in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.