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POMALIDOMIDE SANDOZ (Sandoz Pty Ltd)
Product name
POMALIDOMIDE SANDOZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
108 (255 working days)
Active ingredients
pomalidomide
Registration type
New generic medicine
Indication
POMALIDOMIDE SANDOZ (capsule), in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen including lenalidomide.
POMALIDOMIDE SANDOZ, in combination with dexamethasone, is indicated for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.