CENRIFKI (Sanofi-Aventis Australia Pty Ltd)
Product name
CENRIFKI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
143 (255 working days)
Active ingredients
tolebrutinib
Registration type
NCE/NBE
Indication
CENRIFKI is indicated in adults:
- for the treatment of non-relapsing Secondary Progressive Multiple Sclerosis (nrSPMS)
- to slow disability accumulation in the absence of relapse activity with Secondary Progressive Multiple Sclerosis (SPMS)
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available