Yervoy

RSS

ipilimumab

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

Overview

Yervoy is a medicine that increases the activity of the immune system (the body’s natural defences) and is used to treat patients with advanced melanoma (a type of skin cancer affecting cells called melanocytes). It can be used either alone in adults and children aged from 12 years or with nivolumab (another cancer medicine) in adults.

Yervoy contains the active substance ipilimumab.

This EPAR was last updated on 23/11/2018

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
25
Date of issue of marketing authorisation valid throughout the European Union
12/07/2011
Contact address
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
United Kingdom

Product information

22/11/2018 Yervoy - EMEA/H/C/002213 - IAIN/0062

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

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

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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.

Assessment history

Changes since initial authorisation of medicine

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