OXERVATE (JACE Pharma Pty Ltd)
Product name
OXERVATE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
181 working days (255)
Active ingredients
cenegermin (rbe)
Registration type
NCE/NBE
Indication
OXERVATE (eye drops) is indicated for the treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults.
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.