Onivyde pegylated liposomal (previously Onivyde)
What Onivyde pegylated liposomal (previously Onivyde) is used for
ONIVYDE pegylated liposomal is indicated:- in combination with oxaliplatin, 5 fluorouracil (5 FU) and leucovorin (LV) for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas,- in combination with 5-FU and LV for the treatment of metastatic adenocarcinoma of the pancreas, in adult patients who have progressed following gemcitabine based therapy.
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
Key facts
- Brand
- Onivyde pegylated liposomal (previously Onivyde)
- Active substance
- irinotecan hydrochloride trihydrate
- Disease area
- Pancreatic Neoplasms
- Medicine group
- Antineoplastic agents
- ATC code
- L01CE02
- Marketing authorisation holder
- Les Laboratoires Servier
- Authorised in the EU since
- 2016
Official information
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Onivyde pegylated liposomal (previously Onivyde) used for?
ONIVYDE pegylated liposomal is indicated:- in combination with oxaliplatin, 5 fluorouracil (5 FU) and leucovorin (LV) for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas,- in combination with 5-FU and LV for the treatment of metastatic adenocarcinoma of the pancreas, in adult patients who have progressed following gemcitabine based therapy.
What is the active substance in Onivyde pegylated liposomal (previously Onivyde)?
Onivyde pegylated liposomal (previously Onivyde) contains irinotecan hydrochloride trihydrate.
Who makes Onivyde pegylated liposomal (previously Onivyde)?
The EU marketing authorisation holder is Les Laboratoires Servier.
Is Onivyde pegylated liposomal (previously Onivyde) an orphan medicine?
Yes. Onivyde pegylated liposomal (previously Onivyde) is designated an orphan medicine in the EU, for a rare disease (Pancreatic Neoplasms).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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