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.
Nulojix : EPAR - Summary for the public (PDF/80.21 KB)
First published: 07/07/2011
Last updated: 17/03/2016
Nulojix : EPAR - Risk-management-plan summary (PDF/102.42 KB)
First published: 14/03/2019
Last updated: 08/04/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Bristol-Myers Squibb Pharma EEIG
|Date of issue of marketing authorisation valid throughout the European Union||
03/04/2020 Nulojix - EMEA/H/C/002098 - PSUSA/00000311/201906
- 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
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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.