CARMUSTINE DR REDDY'S, CARMUSTINE-DRLA, CARMUSTINE-JUNO, REDDY'S-CARMUSTINE (Dr Reddys Laboratories Australia Pty Ltd)
Product name
CARMUSTINE DR REDDY'S, CARMUSTINE-DRLA, CARMUSTINE-JUNO, REDDY'S-CARMUSTINE
Date registered
Evaluation commenced
Decision date
Approval time
154 working days (255)
Active ingredients
carmustine
Registration type
New generic medicine
Indication
CARMUSTINE DR REDDY'S, CARMUSTINE-DRLA, CARMUSTINE-JUNO, REDDY'S-CARMUSTINE (powder for injection) is indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following:
- Malignant Glioma
- Multiple Myeloma - in combination with prednisone.
- Hodgkin's Disease - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.
- Non-Hodgkin's lymphomas - as secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy or who fail to respond to primary therapy.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine