Onivyde

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irinotecan hydrochloride trihydrate

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Onivyde. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Onivyde.

For practical information about using Onivyde, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 12/07/2017

Authorisation details

Product details
Name
Onivyde
Agency product number
EMEA/H/C/004125
Active substance
irinotecan hydrochloride trihydrate
International non-proprietary name (INN) or common name
irinotecan hydrochloride trihydrate
Therapeutic area (MeSH)
Pancreatic Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XX19
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
Marketing-authorisation holder
Baxalta Innovations GmbH
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
14/10/2016
Contact address
Industriestrasse 67
A-1221Vienna
AUSTRIA

Product information

22/05/2017 Onivyde - EMEA/H/C/004125 - N/0003

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

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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