DEXRAZOXANE-REACH (Reach Pharmaceuticals Pty Ltd)
Product name
DEXRAZOXANE-REACH
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
193 (255 working days)
Active ingredients
dexrazoxane
Registration type
NCE/ NBE
Indication
DEXRAZOXANE-REACH is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumour control.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.