DACARBAZINE ACCORD (Accord Healthcare Pty Ltd)
Product name
DACARBAZINE ACCORD
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
133 (255 working days)
Active ingredients
Dacarbazine
Registration type
New generic medicine
Indication
Chemotherapy of metastatic malignant melanoma and various sarcomas. In other cancers, the available evidence shows dacarbazine to be ineffective or less effective than established regimens.
Note: The use of dacarbazine is restricted to hospitals with an oncology service.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine