Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: NULOJIX   
Auth. number : EU/1/11/694
INN : belatacept
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AA - Selective immunosuppressive agents
Chemical substance: L04AA28 - Belatacept
(See WHO ATC Index)
Indication: NULOJIX, in combination with corticosteroids and a mycophenolic acid (MPA), is indicated for prophylaxis of graft rejection in adults receiving a renal transplant (see section 5.1 for data on renal function). It is recommended to add an interleukin (IL) 2 receptor antagonist for induction therapy to this belatacept-based regimen.
Marketing Authorisation Holder: Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
23/06/2011 Centralised - Authorisation EMEA/H/C/2098 (2011)4469 of 17/06/2011
15/09/2011 Centralised - Variation EMEA/H/C/2098/IB/1
Updated with Decision(2012)1179 of 14/02/2012
21/02/2012 Centralised - Variation EMEA/H/C/2098/II/4 (2012)1179 of 14/02/2012
20/03/2012 Centralised - Variation EMEA/H/C/2098/IB/3
Updated with Decision(2012)7619 of 23/10/2012
26/10/2012 Centralised - Variation EMEA/H/C/2098/II/6 (2012)7619 of 23/10/2012
11/04/2013 Centralised - Variation EMEA/H/C/2098/II/12 (2013)2102 of 09/04/2013
17/12/2013 Centralised - Variation EMEA/H/C/2098/IA/19