DARZALEX (Janssen-Cilag Pty Ltd)
Product name
DARZALEX
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
174 working days (255)
Active ingredients
daratumumab
Registration type
EOI
Indication
DARZALEX (solution for infusion vial) is now also indicated for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. For use in combination with bortezomib, melphalan and prednisone.