Nulojix

RSS

belatacept

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

Overview

This is a summary of the European public assessment report (EPAR) for Nulojix. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Nulojix.

This EPAR was last updated on 14/03/2019

Authorisation details

Product details
Name
Nulojix
Agency product number
EMEA/H/C/002098
Active substance
belatacept
International non-proprietary name (INN) or common name
belatacept
Therapeutic area (MeSH)
  • Graft Rejection
  • Kidney Transplantation
Anatomical therapeutic chemical (ATC) code
L04AA28
Publication details
Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
17/06/2011
Contact address

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

Product information

28/02/2019 Nulojix - EMEA/H/C/002098 - II/0051

Contents

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

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Nulojix, in combination with corticosteroids and a mycophenolic acid (MPA), is indicated for prophylaxis of graft rejection in adults receiving a renal transplant. It is recommended to add an interleukin (IL)-2-receptor antagonist for induction therapy to this belatacept-based regimen.

Assessment history

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