Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Remicade   
Auth. number : EU/1/99/116
INN : infliximab
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: L04AB02 - Infliximab
(See WHO ATC Index)
Indication: Rheumatoid arthritis
Remicade, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
• adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate.
• adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.
In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated (see section 5.1).

Adult Crohn’s disease
Remicade 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.
• treatment of fistulising, active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).

Paediatric Crohn’s disease
Remicade is indicated for treatment of severe, active Crohn’s disease, in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Remicade has been studied only in combination with conventional immunosuppressive therapy.
Ulcerative colitis
Remicade 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.

Paediatric ulcerative colitis
Remicade is indicated for treatment of severely active ulcerative colitis, in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.

Ankylosing spondylitis
Remicade is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.

Psoriatic arthritis
Remicade is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Remicade should be administered
- in combination with methotrexate
- or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated
Remicade has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with
Marketing Authorisation Holder: Janssen Biologics B.V.
Einsteinweg 101, NL-2333 CB Leiden, Nederland

  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 continues to be 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
25/08/1999 Centralised - Authorisation EMEA/H/C/240 (1999)2683 of 13/08/1999
10/02/2000 Centralised - Variation EMEA/H/C/240/I/2 (2000)178 of 08/02/2000
28/06/2000 Centralised - Variation EMEA/H/C/240/II/1 (2000)1487 of 27/06/2000
20/11/2000 Centralised - Variation EMEA/H/C/240/I/5, 6 (2000)3249 of 15/11/2000
31/01/2001 Centralised - Variation EMEA/H/C/240/II/4 (2001)96 of 29/01/2001
28/02/2001 Centralised - Variation EMEA/H/C/240/N/7 (2001)288 of 23/02/2001
27/06/2001 Centralised - Variation EMEA/H/C/240/II/12 (2001)1362 of 27/06/2001
02/08/2001 Centralised - Variation EMEA/H/C/240/II/9 (2001)2049 of 31/07/2001
02/08/2001 Centralised - Annual reassessment EMEA/H/C/240/S/10 (2001)2048 of 31/07/2001
14/02/2002 Centralised - Variation EMEA/H/C/240/N/14 (2002)515 of 08/02/2002
30/04/2002 Centralised - Variation EMEA/H/C/240/II/11
22/05/2002 Centralised - Variation EMEA/H/C/240/II/16 (2002)1957 of 17/05/2002
22/05/2002 Centralised - Annual reassessment EMEA/H/C/240/S/15 (2002)1956 of 17/05/2002
03/06/2002 Centralised - Variation EMEA/H/C/240/I/19
27/06/2002 Centralised - Variation EMEA/H/C/240/N/20 (2002)2419 of 20/06/2002
04/07/2002 Centralised - Variation EMEA/H/C/240/II/21
15/07/2002 Centralised - Variation EMEA/H/C/240/II/17 (2002)2754 of 11/07/2002
16/10/2002 Centralised - Variation EMEA/H/C/240/II/23 (2002)3983 of 14/10/2002
09/12/2002 Centralised - Variation EMEA/H/C/240/I/26
13/01/2003 Centralised - Variation EMEA/H/C/240/I/27
25/03/2003 Centralised - Variation EMEA/H/C/240/I/31
24/04/2003 Centralised - Variation EMEA/H/C/240/I/34
02/05/2003 Centralised - Variation EMEA/H/C/240/I/30
19/05/2003 Centralised - Variation EMEA/H/C/240/II/29 (2003)1685 of 15/05/2003
19/05/2003 Centralised - Annual reassessment EMEA/H/C/240/S/28 (2003)1683 of 15/05/2003
19/05/2003 Centralised - Variation EMEA/H/C/240/II/24, 25 (2003)1684 of 15/05/2003
14/07/2003 Centralised - Variation EMEA/H/C/240/II/22 (2003)2599 of 10/07/2003
29/07/2003 Centralised - Variation EMEA/H/C/240/I/35
17/09/2003 Centralised - Variation EMEA/H/C/240/I/41
30/09/2003 Centralised - Variation EMEA/H/C/240/I/40
30/09/2003 Centralised - Variation EMEA/H/C/240/I/39
30/09/2003 Centralised - Variation EMEA/H/C/240/II/38
15/10/2003 Centralised - Variation EMEA/H/C/240/I/42
22/10/2003 Centralised - Variation EMEA/H/C/240/II/32 (2003)3962 of 20/10/2003
22/12/2003 Centralised - Variation EMEA/H/C/240/II/43
05/03/2004 Centralised - Variation EMEA/H/C/240/II/47
10/03/2004 Centralised - Annual reassessment EMEA/H/C/240/S/37 (2004)811 of 08/03/2004
11/03/2004 Centralised - Variation EMEA/H/C/240/II/44 (2004)820 of 09/03/2004
10/06/2004 Centralised - Variation EMEA/H/C/240/II/45 (2004)2081 of 08/06/2004
10/06/2004 Centralised - Variation EMEA/H/C/240/II/49 (2004)2082 of 08/06/2004
12/06/2004 Other procedure EMEA/H/C/240/N/51
22/09/2004 Centralised - Renewal EMEA/H/C/240/R/50 (2004)3573 of 20/09/2004
27/09/2004 Centralised - Variation EMEA/H/C/240/II/46 (2004)3615 of 23/09/2004
09/11/2004 Centralised - Variation EMEA/H/C/240/IA/55
23/11/2004 Centralised - Variation EMEA/H/C/240/IA/58
13/12/2004 Centralised - Variation EMEA/H/C/240/IA/59
12/01/2005 Centralised - Variation EMEA/H/C/240/II/53 (2005)67 of 10/01/2005
28/01/2005 Centralised - Variation EMEA/H/C/240/II/56 (2005)231 of 26/01/2005
25/02/2005 Centralised - Variation EMEA/H/C/240/II/60
25/02/2005 Centralised - Variation EMEA/H/C/240/II/52
23/03/2005 Centralised - Variation EMEA/H/C/240/II/57
23/03/2005 Centralised - Variation EMEA/H/C/240/II/48
30/06/2005 Centralised - Variation EMEA/H/C/240/II/64 (2005)2091 of 28/06/2005
30/06/2005 Centralised - Variation EMEA/H/C/240/II/62 (2005)2090 of 28/06/2005
03/08/2005 Centralised - Variation EMEA/H/C/240/II/63 (2005)3049 of 01/08/2005
29/09/2005 Centralised - Variation EMEA/H/C/240/II/70
04/10/2005 Centralised - Variation EMEA/H/C/240/II/68 (2005)3715 of 29/09/2005
04/10/2005 Centralised - Variation EMEA/H/C/240/II/61 (2005)3714 of 29/09/2005
19/10/2005 Centralised - Variation EMEA/H/C/240/II/66
22/11/2005 Centralised - Variation EMEA/H/C/240/II/71
22/11/2005 Centralised - Variation EMEA/H/C/240/II/72
14/12/2005 Centralised - Variation EMEA/H/C/240/IB/74
02/03/2006 Centralised - Variation EMEA/H/C/240/II/65 (2006)704 of 28/02/2006
29/03/2006 Centralised - Variation EMEA/H/C/240/II/76
31/05/2006 Centralised - Variation EMEA/H/C/240/IA/83
08/06/2006 Centralised - Variation EMEA/H/C/240/II/79, 80
06/07/2006 Centralised - Variation EMEA/H/C/240/II/73, 81, 84 (2006)3131 of 04/07/2006
07/08/2006 Centralised - Variation EMEA/H/C/240/II/78, 82
06/09/2006 Centralised - Variation EMEA/H/C/240/II/69, 77 (2006)4080 of 01/09/2006
27/09/2006 Centralised - Variation EMEA/H/C/240/II/86
23/10/2006 Centralised - Variation EMEA/H/C/240/II/89
31/10/2006 Centralised - Variation EMEA/H/C/240/II/85, 87 (2006)5244 of 27/10/2006
09/01/2007 Centralised - Variation EMEA/H/C/240/II/88 (2007)33 of 04/01/2007
06/02/2007 Centralised - Variation EMEA/H/C/240/II/91, 92
01/03/2007 Centralised - Variation EMEA/H/C/240/II/90, 94
29/03/2007 Centralised - Variation EMEA/H/C/240/II/93 (2007)1492 of 27/03/2007
16/04/2007 Centralised - Variation EMEA/H/C/240/IA/99
31/05/2007 Centralised - Variation EMEA/H/C/240/II/75 (2007)2349 of 30/05/2007
01/06/2007 Centralised - Variation EMEA/H/C/240/II/75 (2007)2350 of 30/05/2007
06/06/2007 Centralised - Variation EMEA/H/C/240/II/96
14/06/2007 Centralised - Variation EMEA/H/C/240/IA/103
28/06/2007 Centralised - Variation EMEA/H/C/240/II/97
24/07/2007 Centralised - Variation EMEA/H/C/240/II/102
27/07/2007 Centralised - Variation EMEA/H/C/240/II/98, 101 (2007)3680 of 24/07/2007
01/11/2007 Centralised - Variation EMEA/H/C/240/II/95 (2007)5383 of 30/10/2007
26/11/2007 Centralised - Variation EMEA/H/C/240/II/104
04/12/2007 Centralised - Variation EMEA/H/C/240/II/100, 105, 106 (2007)6092 of 30/11/2007
19/12/2007 Centralised - Variation EMEA/H/C/240/II/109
27/12/2007 Centralised - Variation EMEA/H/C/240/II/108 (2007)6864 of 21/12/2007
28/01/2008 Centralised - Variation EMEA/H/C/240/II/110
10/04/2008 Centralised - Variation EMEA/H/C/240/II/107 (2008)1373 of 08/04/2008
25/04/2008 Centralised - Variation EMEA/H/C/240/II/112 (2008)1698 of 23/04/2008
28/04/2008 Centralised - Variation EMEA/H/C/240/II/111
28/04/2008 Centralised - Variation EMEA/H/C/240/II/113
11/06/2008 Centralised - Variation EMEA/H/C/240/II/116
20/06/2008 Centralised - Variation EMEA/H/C/240/II/115 (2008)3078 of 18/06/2008
14/07/2008 Centralised - Variation EMEA/H/C/240/II/114 (2008)3662 of 10/07/2008
29/07/2008 Centralised - Variation EMEA/H/C/240/II/119
29/07/2008 Centralised - Variation EMEA/H/C/240/II/120
31/07/2008 Centralised - Variation EMEA/H/C/240/II/117 (2008)4169 of 29/07/2008
28/08/2008 Centralised - Variation EMEA/H/C/240/IB/122
Updated with Decision(2009)1710 of 06/03/2009
28/08/2008 Centralised - Variation EMEA/H/C/240/IB/121
Updated with Decision(2009)1710 of 06/03/2009
02/10/2008 Centralised - Variation EMEA/H/C/240/II/118
27/01/2009 Centralised - Variation EMEA/H/C/240/II/123
02/02/2009 Centralised - Variation EMEA/H/C/240/IB/127
06/03/2009 Centralised - Variation EMEA/H/C/240/N/124
Updated with Decision(2009)5484 of 02/07/2009
10/03/2009 Centralised - Variation EMEA/H/C/240/II/125, 126 (2009)1710 of 06/03/2009
15/04/2009 Centralised - Variation EMEA/H/C/240/IB/129
04/06/2009 Centralised - Variation EMEA/H/C/240/II/132
04/06/2009 Centralised - Variation EMEA/H/C/240/II/131
07/07/2009 Centralised - Renewal EMEA/H/C/240/R/128 (2009)5484 of 02/07/2009
07/07/2009 Centralised - Variation EMEA/H/C/240/II/133 (2009)5510 of 03/07/2009
29/07/2009 Centralised - Variation EMEA/H/C/240/II/130
26/08/2009 Centralised - Variation EMEA/H/C/240/IB/136
02/11/2009 Centralised - Variation EMEA/H/C/240/II/135 (2009)8573 of 29/10/2009
12/11/2009 Centralised - Variation EMEA/H/C/240/II/134
17/03/2010 Centralised - Variation EMEA/H/C/240/II/138 (2010)1762 of 15/03/2010
30/03/2010 Centralised - Variation EMEA/H/C/240/II/137 (2010)2187 of 26/03/2010
29/04/2010 Centralised - Variation EMEA/H/C/240/II/139 (2010)2850 of 27/04/2010
27/05/2010 Centralised - Variation EMEA/H/C/240/II/140
06/12/2010 Centralised - Variation EMEA/H/C/240/II/143, 144 (2010)8640 of 29/11/2010
28/01/2011 Centralised - Variation EMEA/H/C/240/IA/151/G
Updated with Decision(2011)1230 of 21/02/2011
01/02/2011 Centralised - Variation EMEA/H/C/240/WS/66 (2011)569 of 27/01/2011
24/02/2011 Centralised - Variation EMEA/H/C/240/II/148
25/02/2011 Centralised - Variation EMEA/H/C/240/II/145, 146 (2011)1230 of 21/02/2011
01/03/2011 Centralised - Variation EMEA/H/C/240/II/149
25/03/2011 Centralised - Variation EMEA/H/C/240/IA/152/G
18/04/2011 Centralised - Variation EMEA/H/C/240/IA/154
Updated with Decision(2011)4457 of 17/06/2011
27/04/2011 Centralised - Variation EMEA/H/C/240/II/141/G, EMEA/H/C/240/II/142 (2011)2951 of 20/04/2011
21/06/2011 Centralised - Variation EMEA/H/C/240/II/147 (2011)4457 of 17/06/2011
28/07/2011 Centralised - Variation EMEA/H/C/240/II/155, 156 (2011)5523 of 26/07/2011
17/10/2011 Centralised - Variation EMEA/H/C/240/IA/160/G
Updated with Decision(2012)774 of 06/02/2012
08/02/2012 Centralised - Variation (2012)774 of 06/02/2012
23/02/2012 Centralised - Variation EMEA/H/C/240/II/150 (2012)1265 of 21/02/2012
22/03/2012 Centralised - Variation EMEA/H/C/240/II/161 (2012)1930 of 19/03/2012
03/12/2012 Centralised - Variation EMEA/H/C/240/II/167, EMEA/H/C/240/WS/312, 314 (2012)8711 of 22/11/2012
21/02/2013 Centralised - Variation EMEA/H/C/240/II/170
Updated with Decision(2013)4948 of 25/07/2013
25/04/2013 Centralised - Variation EMEA/H/C/240/II/172
Updated with Decision(2013)4948 of 25/07/2013
17/05/2013 Centralised - Variation EMEA/H/C/240/IB/173
Updated with Decision(2013)4948 of 25/07/2013
29/07/2013 Centralised - Variation EMEA/H/C/240/WS/400 (2013)4948 of 25/07/2013