Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Orencia   
Auth. number : EU/1/07/389
INN : abatacept
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: L04AA24 - Abatacept
(See WHO ATC Index)
Indication: Rheumatoid arthritis
ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor.
A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate.
Polyarticular juvenile idiopathic arthritis
ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (JIA) in paediatric patients 6 years of age and older who have had an insufficient response to other DMARDs including at least one TNF inhibitor.
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
23/05/2007 Centralised - Authorisation EMEA/H/C/701 (2007)2236 of 21/05/2007
18/09/2007 Centralised - Notification EMEA/H/C/701/N/3
Updated with Decision(2009)1380 of 25/02/2009
21/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/701/II/4
19/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/701/II/2
19/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/701/II/6
14/02/2008 Centralised - Notification EMEA/H/C/701/N/12
Updated with Decision(2009)1380 of 25/02/2009
31/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/701/II/9
03/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/701/IA/16
03/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/701/IA/15
22/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/701/IB/18
22/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/701/IB/17
03/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/701/II/11
26/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/701/II/20
20/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/701/II/21
27/02/2009 Centralised - Variation EMEA/H/C/701/II/22 (2009)1380 of 25/02/2009
19/03/2009 Centralised - Variation EMEA/H/C/701/IB/26
Updated with Decision(2009)4349 of 29/05/2009
03/06/2009 Centralised - Variation EMEA/H/C/701/II/23 (2009)4349 of 29/05/2009
03/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/701/II/28
03/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/701/II/27
18/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/701/II/29
28/08/2009 Centralised - Notification EMEA/H/C/701/N/31
Updated with Decision(2010)407 of 20/01/2010
12/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/701/IA/32
17/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/701/IA/32
21/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/701/IA/36
21/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/701/IA/35
22/01/2010 Centralised - Variation EMEA/H/C/701/II/24 (2010)407 of 20/01/2010
02/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/701/II/34
23/03/2010 Centralised - Variation EMEA/H/C/701/IA/37/G
Updated with Decision(2010)4668 of 01/07/2010
05/07/2010 Centralised - Variation EMEA/H/C/701/II/33 (2010)4668 of 01/07/2010
19/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/701/II/40
03/09/2010 Centralised - Variation EMEA/H/C/701/IA/42
Updated with Decision(2010)8902 of 03/12/2010
29/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/701/II/39
26/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/701/II/41
07/12/2010 Centralised - Variation (2010)8902 of 03/12/2010
26/04/2011 Centralised - Variation EMEA/H/C/701/IA/46
Updated with Decision(2011)4636 of 23/06/2011
27/05/2011 Centralised - Variation EMEA/H/C/701/IA/48
Updated with Decision(2012)761 of 06/02/2012
28/06/2011 Centralised - Variation EMEA/H/C/701/II/43 (2011)4636 of 23/06/2011
26/08/2011 Corrigendum (2010)407 corr of 24/08/2011
08/02/2012 Centralised - Variation (2012)761 of 06/02/2012
19/03/2012 Centralised - Renewal EMEA/H/C/701/R/55 (2012)1860 of 15/03/2012
08/10/2012 Centralised - Variation EMEA/H/C/701/X/54 (2012)7104 of 04/10/2012
19/11/2012 Centralised - Variation EMEA/H/C/701/IA/68
Updated with Decision(2013)8838 of 03/12/2013
17/01/2013 Centralised - Variation EMEA/H/C/701/II/65
Updated with Decision(2013)8838 of 03/12/2013
25/04/2013 Centralised - Variation EMEA/H/C/701/II/70/G
Updated with Decision(2013)8838 of 03/12/2013
25/04/2013 Centralised - Variation EMEA/H/C/701/II/62/G
Updated with Decision(2013)8838 of 03/12/2013
30/05/2013 Centralised - Variation EMEA/H/C/701/II/72
Updated with Decision(2013)8838 of 03/12/2013
06/12/2013 Centralised - Yearly update (2013)8838 of 03/12/2013
30/04/2014 Centralised - 2-Monthly update EMEA/H/C/701/II/77 (2014)2929 of 28/04/2014
18/08/2014 Corrigendum C(2014)2969 Cor of 28/04/2014
25/09/2014 Centralised - Variation EMEA/H/C/701/II/81/G