LENALIDOMIDE-TEVA, TE- LENALIDOMIDE, TE-LENALIDOMIDE (Teva Pharma Australia Pty Ltd)
Product name
LENALIDOMIDE-TEVA, TE- LENALIDOMIDE, TE-LENALIDOMIDE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
146 (175 working days)
Active ingredients
lenalidomide hydrochloride monohydrate
Registration type
New generic medicine
Indication
Multiple Myeloma (MM)
LENALIDOMIDE-TEVA, TE- LENALIDOMIDE, TE-LENALIDOMIDE (capsule) is indicated for the treatment of multiple myeloma.
Myelodysplastic Syndromes (MDS)
LENALIDOMIDE-TEVA, TE- LENALIDOMIDE, TE-LENALIDOMIDE is indicated for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine