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CIPLA LENALIDOMIDE, LENALICIP, LENALIMID (Cipla Australia Pty Ltd)

Product name
CIPLA LENALIDOMIDE, LENALICIP, LENALIMID
Sponsor
Cipla Australia Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
252 working days (255)
Active ingredients
lenalidomide
Registration type
New generic medicine
Indication
Multiple Myeloma (MM)

CIPLA LENALIDOMIDE, LENALICIP, LENALIMID (capsule) are indicated for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.

CIPLA LENALIDOMIDE, LENALICIP, LENALIMID are indicated for the maintenance treatment of patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.

CIPLA LENALIDOMIDE, LENALICIP, LENALIMID in combination with dexamethasone are indicated for the treatment of multiple myeloma patients whose disease has progressed after one therapy.

Myelodysplastic Syndromes (MDS)

CIPLA LENALIDOMIDE, LENALICIP, LENALIMID are 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

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