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DARZALEX SC (Janssen-Cilag Pty Ltd)
Product name
DARZALEX SC
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
237 (255 working days)
Active ingredients
daratumumab
Registration type
EOI
Indication
DARZALEX SC is indicated for the treatment of patients:
- with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. For use in combination bortezomib, lenalidomide, and dexamethasone, followed by maintenance treatment in combination with lenalidomide.