Summary of opinion: Onivyde pegylated liposomal (previously known as Onivyde), 21/03/2024 Positive

On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Onivyde pegylated liposomal.

Metadata

Provider:

European Medicines Agency

URL:

https://www.ema.europa.eu/en/medicines/human/variation/onivyde-pegylated-liposomal-previously-known-onivyde

Retrieved on:

水曜日, 4月 3, 2024

Information

Tags:

European Commission, Civil service commission, Patient, Irinotecan, Oxaliplatin, Committee, Dicarboxylic acid, Medication package insert, Marketing, CHMP, Pancreas

Geotags:

LV, EUROPEAN UNION

概要

Key Points:

On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Onivyde pegylated liposomal.
The marketing authorisation holder for this medicinal product is Les Laboratoires Servier.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
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