RUZURGI (ORSPEC Pharma Pty Ltd)
Product name
RUZURGI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
127 (255 working days)
Active ingredients
amifampridine
Registration type
NCE/NBE
Indication
RUZURGI (tablet) is indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and children aged 6 years and above.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.