CARMUSTINE AJS, CARMUSTINE SXP, CARMUSTINE TLB (Southern Cross Pharma Pty Ltd)
Product name
CARMUSTINE AJS, CARMUSTINE SXP, CARMUSTINE TLB
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
155 (255 working days)
Active ingredients
carmustine
Registration type
New generic medicine
Indication
CARMUSTINE AJS, CARMUSTINE SXP, CARMUSTINE TLB (diluent for injection and 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.