DARZALEX SC (Janssen-Cilag Pty Ltd)
Product name
DARZALEX SC
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
247 (255 working days)
Active ingredients
daratumumab
Registration type
EOI
Indication
DARZALEX SC is indicated for the treatment of patients:
- who are ineligible for autologous stem cell transplant. For use in combination with:
- bortezomib, melphalan and prednisone, or
- lenalidomide and dexamethasone, or
- bortezomib, lenalidomide and dexamethasone.