Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Humira   
Auth. number : EU/1/03/256
INN : Adalimumab
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AB - Tumor necrosis factor alpha (TNF-a) inhibitors
Chemical substance: L04AB04 - Adalimumab
(See WHO ATC Index)
Indication: Rheumatoid arthritis

Humira in combination with methotrexate, is indicated for:

 the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
 the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Humira has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.

Juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis

Humira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. (for the efficacy in monotherapy see section 5.1). Humira has not been studied in patients aged less than 2 years.

Axial spondyloarthritis

Ankylosing spondylitis(AS)

Humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.

Axial spondyloarthritis without radiographic evidence of AS

Humira is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.
Psoriatic arthritis
Humira is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti rheumatic drug therapy has been inadequate. Humira has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see Section 5.1) and to improve physical function.

Psoriasis

Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA.

Crohn’s disease

Humira is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.

Paediatric Crohn's disease

Humira is indicated for the treatment of severe active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy, a corticosteroid, and an immunomodulator, or who are intolerant to or have contraindications for such therapies.

Ulcerative colitis

Humira is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies
Marketing Authorisation Holder: AbbVie Ltd
Maidenhead, SL6 4XE, 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
10/09/2003 Centralised - Authorisation EMEA/H/C/481 (2003)3278 of 08/09/2003
19/12/2003 Centralised - Variation EMEA/H/C/481/II/3
01/03/2004 Centralised - Variation EMEA/H/C/481/II/7
10/05/2004 Centralised - Variation EMEA/H/C/481/N/9
Updated with Decision(2004)2115 of 10/06/2004
14/06/2004 Centralised - Variation EMEA/H/C/481/II/6 (2004)2115 of 10/06/2004
21/07/2004 Centralised - Variation EMEA/H/C/481/II/10 (2004)2879 of 19/07/2004
02/08/2004 Centralised - Variation EMEA/H/C/481/II/11
22/09/2004 Centralised - Variation EMEA/H/C/481/II/8
23/11/2004 Centralised - Variation EMEA/H/C/481/II/13
23/11/2004 Centralised - Variation EMEA/H/C/481/II/14
24/11/2004 Centralised - Variation EMEA/H/C/481/IA/15
21/12/2004 Centralised - Variation EMEA/H/C/481/II/16
27/01/2005 Centralised - Variation EMEA/H/C/481/II/19 (2005)209 of 25/01/2005
25/02/2005 Centralised - Variation EMEA/H/C/481/II/17
27/04/2005 Centralised - Variation EMEA/H/C/484/II/20
27/04/2005 Centralised - Variation EMEA/H/C/481/II/23 (2005)1346 of 25/04/2005
03/08/2005 Centralised - Variation EMEA/H/C/481/II/21, 22 (2005)3040 of 01/08/2005
24/01/2006 Centralised - Variation EMEA/H/C/481/II/24 (2006)152 of 20/01/2006
23/03/2006 Centralised - Variation EMEA/H/C/481/IA/29
Updated with Decision(2006)2249 of 01/06/2006
05/06/2006 Centralised - Variation EMEA/H/C/481/II/26 (2006)2249 of 01/06/2006
07/06/2006 Centralised - Variation EMEA/H/C/481/II/28
03/08/2006 Centralised - Variation EMEA/H/C/481/II/32
03/08/2006 Centralised - Variation EMEA/H/C/481/II/31
09/11/2006 Centralised - Variation EMEA/H/C/481/II/27, 30 (2006)5422 of 07/11/2006
07/03/2007 Centralised - Variation EMEA/H/C/481/II/34, 35 (2007)820 of 05/03/2007
16/05/2007 Centralised - Variation EMEA/H/C/481/II/36 (2007)2146 of 14/05/2007
06/06/2007 Centralised - Variation EMEA/H/C/481/II/33 (2007)2448 of 04/06/2007
05/07/2007 Centralised - Variation EMEA/H/C/481/II/37 (2007)3288 of 29/06/2007
23/07/2007 Centralised - Variation EMEA/H/C/481/II/41
31/07/2007 Corrigendum (2003)2328 corr of 26/07/2007
11/10/2007 Centralised - Variation EMEA/H/C/481/II/42 (2007)5059 of 09/10/2007
21/12/2007 Centralised - Variation EMEA/H/C/481/II/38 (2007)6765 of 19/12/2007
21/01/2008 Centralised - Variation EMEA/H/C/481/II/43 (2008)293 of 17/01/2008
28/01/2008 Centralised - Variation EMEA/H/C/481/II/44
04/02/2008 Centralised - Variation EMEA/H/C/481/IA/46
05/03/2008 Centralised - Variation EMEA/H/C/481/IA/50
05/03/2008 Centralised - Variation EMEA/H/C/481/IA/48
05/03/2008 Centralised - Variation EMEA/H/C/481/IA/49
31/03/2008 Centralised - Variation EMEA/H/C/481/II/45
03/06/2008 Centralised - Variation EMEA/H/C/481/IA/58
16/06/2008 Centralised - Variation EMEA/H/C/484/IA/59
Updated with Decision(2008)4534 of 13/08/2008
25/06/2008 Centralised - Variation EMEA/H/C/481/II/47 (2008)3230 of 23/06/2008
01/07/2008 Centralised - Variation EMEA/H/C/481/IB/55
Updated with Decision(2008)4534 of 13/08/2008
22/07/2008 Centralised - Variation EMEA/H/C/481/II/54
23/07/2008 Centralised - Variation EMEA/H/C/481/II/52, 53 (2008)3916 of 17/07/2008
31/07/2008 Centralised - Variation EMEA/H/C/481/IA/60
15/08/2008 Centralised - Variation EMEA/H/C/481/II/56 (2008)4534 of 13/08/2008
27/08/2008 Centralised - Variation EMEA/H/C/481/II/39 (2008)4673 of 25/08/2008
02/09/2008 Centralised - Renewal EMEA/H/C/481/R/51 (2008)4769 of 29/08/2008
27/02/2009 Centralised - Variation EMEA/H/C/481/II/62 (2009)1386 of 25/02/2009
07/04/2009 Centralised - Variation EMEA/H/C/481/N/63
Updated with Decision(2009)6068 of 24/07/2009
06/07/2009 Centralised - Variation EMEA/H/C/481/II/65
30/07/2009 Centralised - Variation EMEA/H/C/481/II/61 (2009)6068 of 24/07/2009
01/09/2009 Centralised - Variation EMEA/H/C/481/II/64, 66 (2009)6727 of 28/08/2009
27/10/2009 Centralised - Variation EMEA/H/C/481/II/67
10/12/2009 Centralised - Variation EMEA/H/C/481/IA/69
Updated with Decision(2010)1778 of 15/03/2010
17/03/2010 Centralised - Variation (2010)1778 of 15/03/2010
25/03/2010 Centralised - Variation EMEA/H/C/481/II/68 (2010)2029 of 23/03/2010
04/05/2010 Centralised - Variation EMEA/H/C/481/II/70, 73 (2010)2942 of 29/04/2010
07/06/2010 Centralised - Variation EMEA/H/C/481/II/71 (2010)3634 of 02/06/2010
05/07/2010 Centralised - Variation EMEA/H/C/481/II/72 (2010)4666 of 01/07/2010
22/07/2010 Centralised - Variation EMEA/H/C/481/IA/76
03/08/2010 Centralised - Variation EMEA/H/C/481/IA/77
03/09/2010 Centralised - Variation EMEA/H/C/481/II/74 (2010)6104 of 31/08/2010
25/11/2010 Centralised - Variation EMEA/H/C/481/II/79
26/11/2010 Centralised - Variation EMEA/H/C/481/II/78
25/01/2011 Centralised - Variation EMEA/H/C/481/II/80 (2011)390 of 21/01/2011
23/02/2011 Centralised - Variation EMEA/H/C/481/II/75 (2011)1192 of 21/02/2011
23/03/2011 Centralised - Variation EMEA/H/C/481/II/81/G (2011)1923 of 18/03/2011
26/10/2011 Centralised - Variation EMEA/H/C/481/II/84 (2011)7796 of 24/10/2011
21/12/2011 Centralised - Variation EMEA/H/C/481/II/83 (2011)9945 of 19/12/2011
24/01/2012 Centralised - Variation EMEA/H/C/481/II/87 (2012)414 of 20/01/2012
10/04/2012 Centralised - Variation EMEA/H/C/481/II/82, 91 (2012)2412 of 04/04/2012
25/04/2012 Centralised - Variation EMEA/H/C/481/II/86/G (2012)2821 of 20/04/2012
02/07/2012 Centralised - Variation EMEA/H/C/481/II/93 (2012)4508 of 27/06/2012
27/07/2012 Centralised - Variation EMEA/H/C/481/II/85, 96, 100, 97 (2012)5352 of 23/07/2012
28/08/2012 Centralised - Variation EMEA/H/C/481/II/94 (2012)6039 of 23/08/2012
26/10/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/481/T/106 (2012)7618 of 23/10/2012
26/10/2012 Centralised - Variation EMEA/H/C/481/II/92 (2012)7647 of 24/10/2012
26/11/2012 Centralised - Variation EMEA/H/C/481/II/88, 104, 105 (2012)8704 of 22/11/2012
29/11/2012 Centralised - Variation EMEA/H/C/481/N/109
Updated with Decision(2013)1190 of 25/02/2013
12/12/2012 Centralised - Variation EMEA/H/C/481/IAin/111/G
Updated with Decision(2013)1190 of 25/02/2013
13/12/2012 Centralised - Variation EMEA/H/C/481/II/99/G
Updated with Decision(2013)1190 of 25/02/2013
06/02/2013 Centralised - Variation EMEA/H/C/481/IA/112
Updated with Decision(2014)788 of 06/02/2014
21/02/2013 Centralised - Variation EMEA/H/C/481/II/95
Updated with Decision(2014)788 of 06/02/2014
27/02/2013 Centralised - Variation EMEA/H/C/481/II/102, 107 (2013)1190 of 25/02/2013
22/03/2013 Centralised - Variation EMEA/H/C/481/IA/115
Updated with Decision(2014)788 of 06/02/2014
29/05/2013 Centralised - Variation EMEA/H/C/481/N/117
Updated with Decision(2014)788 of 06/02/2014
22/08/2013 Centralised - Variation EMEA/H/C/481/IB/122
Updated with Decision(2014)788 of 06/02/2014
19/09/2013 Centralised - Variation EMEA/H/C/481/II/120
Updated with Decision(2014)788 of 06/02/2014
10/02/2014 Corrigendum (2014)789 of 06/02/2014
10/02/2014 Centralised - Variation (2014)788 of 06/02/2014
20/03/2014 Centralised - Variation EMEA/H/C/481/II/123
25/04/2014 Centralised - Variation EMEA/H/C/481/II/129
19/08/2014 Centralised - Variation EMEA/H/C/481/N/133