Onivyde pegylated liposomal (previously known as Onivyde)


irinotecan hydrochloride trihydrate

This medicine is authorised for use in the European Union.


Onivyde pegylated liposomal is a cancer medicine that is used to treat a form of pancreatic cancer called metastatic adenocarcinoma of the pancreas. Metastatic means that the cancer has spread to other parts of the body. Onivyde pegylated liposomal is used together with fluorouracil and leucovorin (also called folinate) (other medicines used for cancer) in adults whose cancer has got worse despite treatment containing the cancer medicine gemcitabine.

Onivyde pegylated liposomal contains the active substance irinotecan.

Pancreatic cancer is rare, and Onivyde pegylated liposomal was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 9 December 2011. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu311933.

This EPAR was last updated on 13/12/2022

Authorisation details

Product details
Onivyde pegylated liposomal (previously known as Onivyde)
Agency product number
Active substance
irinotecan anhydrous free-base
International non-proprietary name (INN) or common name
irinotecan hydrochloride trihydrate
Therapeutic area (MeSH)
Pancreatic Neoplasms
Anatomical therapeutic chemical (ATC) code

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Les Laboratoires Servier
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Les Laboratoires Servier
50 rue Carnot
F-92284 Suresnes Cedex

Product information

22/08/2022 Onivyde pegylated liposomal (previously known as Onivyde) - EMEA/H/C/004125 - PSUSA/00010534/202110

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You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Treatment of metastatic adenocarcinoma of the pancreas, in combination with 5 fluorouracil (5 FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine based therapy.

Assessment history

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