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MSN-BORTEZOMIB (Plunkett Consulting Pty Ltd)
Product name
MSN-BORTEZOMIB
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
152 working days (255)
Active ingredients
bortezomib
Registration type
New generic medicine
Indication
MSN-BORTEZOMIB (powder for injection), 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.
MSN-BORTEZOMIB 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.
MSN-BORTEZOMIB is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.
MSN-BORTEZOMIB in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.