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BORTEZOM, BORTEZOMIB GXP, BORTEZOMIB GPPL, BORTEZOMIB HETERO, BORTEZOTERO (Hetero Australia Pty Ltd)
Product name
BORTEZOM, BORTEZOMIB GXP, BORTEZOMIB GPPL, BORTEZOMIB HETERO, BORTEZOTERO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
241 (255 working days)
Active ingredients
bortezomib
Registration type
New generic medicine
Indication
BORTEZOM, BORTEZOMIB GXP, BORTEZOMIB GPPL, BORTEZOMIB HETERO, BORTEZOTERO (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.
BORTEZOM, BORTEZOMIB GXP, BORTEZOMIB GPPL, BORTEZOMIB HETERO, BORTEZOTERO, 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.
BORTEZOM, BORTEZOMIB GXP, BORTEZOMIB GPPL, BORTEZOMIB HETERO, BORTEZOTERO is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who gave progressive disease.