Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Enbrel   
Auth. number : EU/1/99/126
INN : Etanercept
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: L04AB01 - Etanercept
(See WHO ATC Index)
Indication: Rheumatoid arthritis
Enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.

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

Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

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

Juvenile idiopathic arthritis
Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.

Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.

Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.

Enbrel has not been studied in children aged less than 2 years.

Psoriatic arthritis
Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel 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 polyarticular symmetrical subtypes of the disease.

Axial spondyloarthritis

Ankylosing spondylitis (AS)
Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.

Non-radiographic axial spondyloarthritis
Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).

Plaque psoriasis
Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA) (see section 5.1).

Paediatric plaque psoriasis
Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, 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
09/02/2000 Centralised - Authorisation EMEA/H/C/262 (2000)175 of 03/02/2000
14/03/2001 Centralised - Variation EMEA/H/C/262/I/3 (2001)520 of 13/03/2001
25/04/2001 Centralised - Variation EMEA/H/C/262/II/1, 13 (2001)849 of 23/04/2001
03/05/2001 Centralised - Variation EMEA/H/C/262/II/5, 12, 14
21/05/2001 Centralised - Variation EMEA/H/C/262/I/15 (2001)1230 of 17/05/2001
31/07/2001 Centralised - Variation EMEA/H/C/262/I/20
08/08/2001 Centralised - Variation EMEA/H/C/262/N/21 (2001)2092 of 06/08/2001
15/10/2001 Centralised - Variation EMEA/H/C/262/II/18
25/10/2001 Centralised - Variation EMEA/H/C/262/II/19
20/12/2001 Centralised - Variation EMEA/H/C/262/II/22 (2001)4322 of 17/12/2001
23/01/2002 Centralised - Variation EMEA/H/C/262/II/24
08/02/2002 Centralised - Variation EMEA/H/C/262/II/17 (2002)502 of 06/02/2002
22/02/2002 Centralised - Variation EMEA/H/C/262/I/26
18/09/2002 Centralised - Variation EMEA/H/C/262/II/28 (2002)3424 of 16/09/2002
18/09/2002 Centralised - Variation EMEA/H/C/262/II/27 (2002)3425 of 16/09/2002
10/12/2002 Centralised - Variation EMEA/H/C/262/II/25 (2002)5018 of 05/12/2002
24/04/2003 Centralised - Variation EMEA/H/C/262/II/30 (2003)1403 of 22/04/2003
30/06/2003 Centralised - Variation EMEA/H/C/262/II/29 (2003)2119 of 26/06/2003
07/08/2003 Centralised - Variation EMEA/H/C/262/II/32
15/08/2003 Centralised - Variation EMEA/H/C/262/II/31 (2003)3050 of 13/08/2003
28/10/2003 Centralised - Variation EMEA/H/C/262/II/34 (2003)4021 of 24/10/2003
28/10/2003 Centralised - Variation EMEA/H/C/262/II/35
19/12/2003 Centralised - Variation EMEA/H/C/262/IB/38
20/01/2004 Centralised - Variation EMEA/H/C/262/II/33 (2004)120 of 16/01/2004
10/02/2004 Centralised - Variation EMEA/H/C/262/IB/39
01/03/2004 Centralised - Variation EMEA/H/C/262/IB/41
12/05/2004 Centralised - Variation EMEA/H/C/262/II/36 (2004)1867 of 10/05/2004
09/06/2004 Centralised - Variation EMEA/H/C/262/II/43
27/07/2004 Centralised - Variation EMEA/H/C/262/II/42 (2004)2934 of 23/07/2004
27/07/2004 Centralised - Variation EMEA/H/C/262/II/37 (2004)2933 of 23/07/2004
30/07/2004 Centralised - Variation EMEA/H/C/262/IA/49
22/09/2004 Centralised - Variation EMEA/H/C/262/IB/51
23/09/2004 Centralised - Variation EMEA/H/C/262/II/44
28/09/2004 Centralised - Variation EMEA/H/C/262/II/40 (2004)3650 of 24/09/2004
08/10/2004 Centralised - Variation EMEA/H/C/262/IB/52
Updated with Decision(2005)813 of 10/03/2005
05/11/2004 Centralised - Variation EMEA/H/C/262/II/45, 46
05/11/2004 Centralised - Variation EMEA/H/C/262/II/50
14/03/2005 Centralised - Variation EMEA/H/C/262/II/48 (2005)815 of 10/03/2005
14/03/2005 Centralised - Renewal EMEA/H/C/262/R/53 (2005)813 of 10/03/2005
22/03/2005 Centralised - Variation EMEA/H/C/262/II/55
22/03/2005 Centralised - Variation EMEA/H/C/262/II/56
29/03/2005 Centralised - Variation EMEA/H/C/262/IB/58
02/05/2005 Centralised - Variation EMEA/H/C/262/IA/59
Updated with Decision(2005)2893 of 22/07/2005
03/05/2005 Centralised - Variation EMEA/H/C/262/X/47 (2005)1417 of 28/04/2005
22/06/2005 Centralised - Variation EMEA/H/C/262/IA/61
Updated with Decision(2005)2893 of 22/07/2005
12/07/2005 Centralised - Variation EMEA/H/C/262/IA/62
26/07/2005 Centralised - Variation EMEA/H/C/262/II/57 (2005)2893 of 22/07/2005
03/08/2005 Centralised - Variation EMEA/H/C/262/II/54 (2005)3045 of 01/08/2005
26/10/2005 Centralised - Variation EMEA/H/C/262/IB/64
10/01/2006 Centralised - Variation EMEA/H/C/262/IA/68
03/03/2006 Centralised - Variation EMEA/H/C/262/II/67
15/03/2006 Centralised - Variation EMEA/H/C/262/II/60 (2006)848 of 13/03/2006
05/04/2006 Centralised - Variation EMEA/H/C/262/II/66 (2006)1509 of 03/04/2006
12/04/2006 Centralised - Variation EMEA/H/C/262/IA/71
03/05/2006 Centralised - Variation EMEA/H/C/262/II/70
11/05/2006 Corrigendum EMEA/H/C/262/II/66
02/06/2006 Centralised - Variation EMEA/H/C/262/II/69 (2006)2229 of 31/05/2006
08/08/2006 Centralised - Variation EMEA/H/C/262/X/63 (2006)3639 of 04/08/2006
28/09/2006 Centralised - Variation EMEA/H/C/262/II/73
28/09/2006 Centralised - Variation EMEA/H/C/262/X/65 (2006)4343 of 26/09/2006
24/10/2006 Centralised - Variation EMEA/H/C/262/II/74 (2006)5115 of 20/10/2006
01/12/2006 Centralised - Variation EMEA/H/C/262/II/75 (2006)5926 of 29/11/2006
15/12/2006 Centralised - Variation EMEA/H/C/262/IA/78
22/01/2007 Centralised - Variation EMEA/H/C/262/II/72 (2007)194 of 18/01/2007
04/04/2007 Centralised - Variation EMEA/H/C/262/II/76 (2007)1600 of 02/04/2007
30/05/2007 Centralised - Variation EMEA/H/C/262/II/80
23/07/2007 Centralised - Variation EMEA/H/C/262/II/81
31/08/2007 Centralised - Variation EMEA/H/C/262/II/79, 82 (2007)4109 of 29/08/2007
01/10/2007 Centralised - Variation EMEA/H/C/262/N/86
Updated with Decision(2007)5150 of 15/10/2007
08/10/2007 Centralised - Variation EMEA/H/C/262/IA/89
18/10/2007 Centralised - Variation EMEA/H/C/262/II/85 (2007)5150 of 15/10/2007
21/11/2007 Centralised - Variation EMEA/H/C/262/II/77, EMEA/H/C/II/262/87, 88 (2007)5659 of 19/11/2007
21/12/2007 Centralised - Variation EMEA/H/C/262/II/90
28/02/2008 Centralised - Variation EMEA/H/C/262/II/83
02/07/2008 Centralised - Variation EMEA/H/C/262/II/92
02/07/2008 Centralised - Variation EMEA/H/C/262/II/91
09/07/2008 Centralised - Variation EMEA/H/C/262/II/93 (2008)3554 of 07/07/2008
21/08/2008 Centralised - Variation EMEA/H/C/262/IA/98
02/09/2008 Centralised - Variation EMEA/H/C/262/II/97 (2008)4767 of 29/08/2008
23/12/2008 Centralised - Variation EMEA/H/C/262/II/95
23/12/2008 Centralised - Variation EMEA/H/C/262/II/999
23/12/2008 Centralised - Variation EMEA/H/C/262/II/100
23/12/2008 Centralised - Variation EMEA/H/C/262/II/96
24/12/2008 Centralised - Variation EMEA/H/C/262/II/94 (2008)8969 of 22/12/2008
23/03/2009 Centralised - Variation EMEA/H/C/262/II/104
27/03/2009 Centralised - Variation EMEA/H/C/262/II/103 (2009)2318 of 25/03/2009
03/06/2009 Centralised - Variation EMEA/H/C/262/II/106, 107 (2009)4352 of 29/05/2009
04/06/2009 Centralised - Variation EMEA/H/C/262/II/105
21/07/2009 Centralised - Variation EMEA/H/C/262/II/101, 102, 108 (2009)5829 of 16/07/2009
23/09/2009 Centralised - Variation EMEA/H/C/262/IA/114
01/10/2009 Centralised - Variation EMEA/H/C/262/II/109
29/10/2009 Centralised - Variation EMEA/H/C/262/II/112
11/11/2009 Centralised - Variation EMEA/H/C/262/IA/115
26/11/2009 Centralised - Variation EMEA/H/C/262/II/113
01/12/2009 Centralised - Renewal EMEA/H/C/262/R/110 (2009)9595 of 26/11/2009
01/12/2009 Centralised - Variation EMEA/H/C/262/II/111 (2009)9596 of 26/11/2009
23/02/2010 Centralised - Variation EMEA/H/C/262/N/118
Updated with Decision(2010)3065 of 05/05/2010
28/04/2010 Centralised - Variation EMEA/H/C/262/II/116
07/05/2010 Centralised - Variation EMEA/H/C/262/II/119 (2010)3065 of 05/05/2010
31/05/2010 Centralised - Variation EMEA/H/C/262/IA/125
Updated with Decision(2010)8524 of 26/11/2010
31/05/2010 Centralised - Variation EMEA/H/C/262/IA/124
Updated with Decision(2010)8524 of 26/11/2010
31/05/2010 Centralised - Variation EMEA/H/C/262/IA/123
Updated with Decision(2010)8524 of 26/11/2010
31/05/2010 Centralised - Variation EMEA/H/C/262/IA/122
Updated with Decision(2010)8524 of 26/11/2010
31/05/2010 Centralised - Variation EMEA/H/C/262/IA/121
Updated with Decision(2010)8524 of 26/11/2010
06/07/2010 Centralised - Variation EMEA/H/C/262/II/117 (2010)4681 of 01/07/2010
16/08/2010 Centralised - Variation EMEA/H/C/262/IB/128/G
12/10/2010 Centralised - Variation EMEA/H/C/262/IB/131
Updated with Decision(2010)8524 of 26/11/2010
22/11/2010 Centralised - Variation EMEA/H/C/262/IB/132
Updated with Decision(2011)397 of 21/01/2011
01/12/2010 Centralised - Variation EMEA/H/C/262/II/130 (2010)8524 of 26/11/2010
14/12/2010 Centralised - Variation EMEA/H/C/262/IB/133
25/01/2011 Centralised - Variation EMEA/H/C/262/II/120 (2011)397 of 21/01/2011
25/02/2011 Centralised - Variation EMEA/H/C/262/II/129 (2011)1228 of 21/02/2011
16/05/2011 Centralised - Variation EMEA/H/C/262/IB/137
Updated with Decision(2011)4847 of 29/06/2011
16/05/2011 Centralised - Variation EMEA/H/C/262/IA/138
Updated with Decision(2011)4847 of 29/06/2011
31/05/2011 Centralised - Variation EMEA/H/C/262/II/135, EMEA/H/C/262/WS/117 (2011)3882 of 27/05/2011
01/07/2011 Centralised - Variation EMEA/H/C/262/X/127 (2011)4817 of 29/06/2011
05/07/2011 Centralised - Variation EMEA/H/C/262/II/136 (2011)4847 of 29/06/2011
10/08/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/262/T/140 (2011)5820 of 05/08/2011
09/09/2011 Centralised - Variation EMEA/H/C/262/II/126, 134, 139 (2011)6186 of 24/08/2011
10/01/2012 Centralised - Variation EMEA/H/C/262/IA/144
Updated with Decision(2012)5615 of 31/07/2012
03/08/2012 Centralised - Variation EMEA/H/C/262/II/145 (2012)5615 of 31/07/2012
03/09/2012 Centralised - Variation EMEA/H/C/262/II/152 (2012)6130 of 30/08/2012
26/10/2012 Centralised - Variation EMEA/H/C/262/II/151, 154 (2012)7641 of 24/10/2012
15/11/2012 Centralised - Variation EMEA/H/C/262/II/156
Updated with Decision(2013)8061 of 13/11/2013
21/02/2013 Centralised - Variation EMEA/H/C/262/II/161
Updated with Decision(2013)8061 of 13/11/2013
30/05/2013 Centralised - Variation EMEA/H/C/262/II/162
Updated with Decision(2013)8061 of 13/11/2013
25/07/2013 Centralised - Variation EMEA/H/C/262/II/164
Updated with Decision(2013)8061 of 13/11/2013
19/09/2013 Centralised - Variation EMEA/H/C/262/II/163
Updated with Decision(2013)8061 of 13/11/2013
10/10/2013 Centralised - Variation EMEA/H/C/262/IB/165
Updated with Decision(2013)8061 of 13/11/2013
15/11/2013 Centralised - Variation (2013)8061 of 13/11/2013
09/01/2014 Centralised - Variation EMEA/H/C/262/IB/169