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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.