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ONIVYDE (Servier Laboratories (Aust) Pty Ltd)
Product name
ONIVYDE
Date registered
Evaluation commenced
Decision date
Approval time
137 (255 working days)
Active ingredients
irinotecan hydrochloride trihydrate
Registration type
EOI
Indication
ONIVYDE is now also indicated in combination with oxaliplatin and 5-fluorouracil (5-FU) and leucovorin (LV) for the first-line treatment of metastatic pancreatic adenocarcinoma.
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.