Yervoy (ipilimumab), MAH: Bristol-Myers Squibb Pharma EEIG
date: 04/02/2025
See also: Summary of positive opinion
On 30 January 2025, 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 Yervoy.
The CHMP adopted a new indication as follows:
Hepatocellular carcinoma (HCC)
YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.
The full indication for Yervoy is described in the Summary of Opinion.
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 made available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.