Onivyde pegylated liposomal (previously known as Onivyde)
irinotecan hydrochloride trihydrate
Table of contents
Overview
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.
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List item
Onivyde : EPAR - Medicine overview (PDF/120.73 KB)
First published: 25/10/2016
Last updated: 29/04/2021
EMA/632019/2019 -
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Oniyde : EPAR - Risk-management-plan summary (PDF/149.72 KB)
First published: 20/02/2019
Last updated: 13/12/2022
Authorisation details
Product details | |
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Name |
Onivyde pegylated liposomal (previously known as Onivyde)
|
Agency product number |
EMEA/H/C/004125
|
Active substance |
irinotecan anhydrous free-base
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International non-proprietary name (INN) or common name |
irinotecan hydrochloride trihydrate
|
Therapeutic area (MeSH) |
Pancreatic Neoplasms
|
Anatomical therapeutic chemical (ATC) code |
L01CE02
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Orphan |
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 | |
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Marketing-authorisation holder |
Les Laboratoires Servier
|
Revision |
11
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Date of issue of marketing authorisation valid throughout the European Union |
14/10/2016
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Contact address |
Les Laboratoires Servier |
Product information
22/08/2022 Onivyde pegylated liposomal (previously known as Onivyde) - EMEA/H/C/004125 - PSUSA/00010534/202110
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.