POMALIDOMIDE JN, POMALIDOMIDE JUNO, POMOLIDE (Juno Pharmaceuticals Pty Ltd)
Product name
POMALIDOMIDE JN, POMALIDOMIDE JUNO, POMOLIDE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
148 (255 working days)
Active ingredients
pomalidomide
Registration type
New generic medicine
Indication
POMALIDOMIDE JN, POMALIDOMIDE JUNO, POMOLIDE (hard 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 JN, POMALIDOMIDE JUNO, POMOLIDE, 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.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine