ERLYAND, JANSSEN APALUTAMIDE (Janssen-Cilag Pty Ltd)
Product name
ERLYAND, JANSSEN APALUTAMIDE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
80 working days (255)
Active ingredients
apalutamide
Registration type
NCE/NBE
Indication
ERLYAND, JANSSEN APALUTAMIDE (tablets) is indicated for the treatment of patients with non-metastatic, castration-resistant prostate cancer.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available