Yervoy

RSS

ipilimumab

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

Overview

Yervoy is a cancer medicine used in adults and adolescents from 12 years of age with advanced melanoma (a type of skin cancer) and in adults with advanced renal cell carcinoma (a kidney cancer).

Yervoy is usually used in combination with another medicine, nivolumab, but can also be used on its own for melanoma.

For renal cell carcinoma, Yervoy is given to patients who have not been treated before and are at moderate or high risk of their cancer getting worse.

Yervoy contains the active substance ipilimumab.

This EPAR was last updated on 05/03/2019

Authorisation details

Product details
Name
Yervoy
Agency product number
EMEA/H/C/002213
Active substance
Ipilimumab
International non-proprietary name (INN) or common name
ipilimumab
Therapeutic area (MeSH)
Melanoma
Anatomical therapeutic chemical (ATC) code
L01XC11
Publication details
Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
Revision
27
Date of issue of marketing authorisation valid throughout the European Union
12/07/2011
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland

Product information

15/02/2019 Yervoy - EMEA/H/C/002213 - IG/1059

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Melanoma

YERVOY as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults, and adolescents 12 years of age and older.

YERVOY in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression.

Renal Cell Carcinoma (RCC)

YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma.

Assessment history

Changes since initial authorisation of medicine

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