We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
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.