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CENRIFKI Sanofi-Aventis Australia Pty Ltd
Product name
CENRIFKI
Sponsor
Accepted date
Aug-2025
Active ingredients
tolebrutinib
Proposed indication
Cenrifki (tolebrutinib) blocks a protein in the brain called BTK. It is proposed for use in adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS) to help slow down disability progression, whether or not relapses are occuring. Rather than distinct episodes of new symptoms, nrSPMS exhibits gradual deterioration of neurological function.
Application type
A (new medicine)
Publication date
Aug-2025
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available.