Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Simponi   
Auth. number : EU/1/09/546
Active substance : golimumab
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: L04AB06 - Golimumab
(See WHO ATC Index)
Indication: Rheumatoid arthritis (RA)
Simponi, in combination with methotrexate (MTX), is indicated for:
• the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease modifying anti rheumatic drug (DMARD) therapy including MTX has been inadequate.
• the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX.

Simponi, in combination with MTX, 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
Polyarticular juvenile idiopathic arthritis (pJIA)
Simponi in combination with MTX is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children with a body weight of at least 40 kg, who have responded inadequately to previous therapy with MTX.

Psoriatic arthritis (PsA)
Simponi, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Simponi 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.

Axial spondyloarthritis
Ankylosing spondylitis (AS)
Simponi is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.

Non radiographic axial spondyloarthritis (nr Axial SpA)
Simponi is indicated for the treatment of adults with severe, active 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, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).

Ulcerative colitis (UC)
Simponi 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: 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 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
05/10/2009 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/992 (2009)7654 of 01/10/2009
06/10/2009 Centralised - Authorisation EMEA/H/C/992 (2009)7653 of 01/10/2009
17/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/992/IA/1
23/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/992/II/6
25/03/2010 Centralised - Variation EMEA/H/C/992/II/2, 3, 4 (2010)2031 of 23/03/2010
01/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/992/II/5
04/06/2010 Centralised - Variation EMEA/H/C/992/IG/7
Updated with Decision(2010)5389 of 28/07/2010
02/08/2010 Centralised - Variation EMEA/H/C/992/II/10 (2010)5389 of 28/07/2010
27/10/2010 Centralised - Variation EMEA/H/C/992/II/9 (2010)7547 of 25/10/2010
01/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/992/IB/19
16/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/992/IA/16/G
01/12/2010 Centralised - Variation EMEA/H/C/992/IA/17
Updated with Decision(2011)560 of 27/01/2011
19/01/2011 Centralised - Variation EMEA/H/C/992/IA/22/G
Updated with Decision(2011)1185 of 21/02/2011
27/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/992/IB/20/G
31/01/2011 Centralised - Variation EMEA/H/C/992/II/8, 14, 15, EMEA/H/C/992/WS/66 (2011)560 of 27/01/2011
23/02/2011 Centralised - Variation EMEA/H/C/992/II/18 (2011)1185 of 21/02/2011
25/04/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/992/II/23/G
27/04/2011 Centralised - Variation EMEA/H/C/992/II/13 (2011)2937 of 20/04/2011
01/06/2011 Centralised - Variation EMEA/H/C/992/II/21, 24, 25 (2011)3871 of 27/05/2011
07/09/2011 Centralised - Variation EMEA/H/C/992/II/26 (2011)6376 of 05/09/2011
08/02/2012 Centralised - Variation EMEA/H/C/992/II/27 (2012)763 of 06/02/2012
12/09/2012 Centralised - Variation EMEA/H/C/992/II/35 (2012)6397 of 10/09/2012
23/11/2012 Centralised - Variation EMEA/H/C/992/WS/312, 314 (2012)8595 of 19/11/2012
21/03/2013 Centralised - Variation EMEA/H/C/992/II/44
Updated with Decision(2013)4943 of 25/07/2013
25/07/2013 Centralised - Variation EMEA/H/C/992/II/46
29/07/2013 Centralised - 2-Monthly update EMEA/H/C/992/WS/400 (2013)4943 of 25/07/2013
05/09/2013 Centralised - Variation EMEA/H/C/992/X/40 (2013)5753 of 03/09/2013
23/09/2013 Centralised - 2-Monthly update EMEA/H/C/992/II/39, 46 (2013)6224 of 19/09/2013
07/10/2013 Centralised - Variation EMEA/H/C/992/IB/50
Updated with Decision(2014)4262 of 19/06/2014
22/11/2013 Centralised - Variation EMEA/H/C/992/IA/51
Updated with Decision(2014)4262 of 19/06/2014
05/03/2014 Centralised - Notification EMEA/H/C/992/N/54
Updated with Decision(2014)4262 of 19/06/2014
22/05/2014 Centralised - Variation EMEA/H/C/992/II/53/G
Updated with Decision(2015)221 of 15/01/2015
23/06/2014 Centralised - Renewal EMEA/H/C/992/R/56 (2014)4262 of 19/06/2014
26/06/2014 Centralised - Variation EMEA/H/C/992/II/55
Updated with Decision(2015)221 of 15/01/2015
25/09/2014 Centralised - Variation EMEA/H/C/992/II/59
Updated with Decision(2015)221 of 15/01/2015
19/01/2015 PSUSA - Modification EMEA/H/C/992/PSUR/58 (2015)221 of 15/01/2015
24/04/2015 Centralised - Variation EMEA/H/C/992/IB/64
Updated with Decision(2015)4365 of 22/06/2015
24/06/2015 Centralised - 2-Monthly update EMEA/H/C/992/II/61 (2015)4365 of 22/06/2015
19/11/2015 Centralised - Variation EMEA/H/C/992/II/65/G
Updated with Decision(2016)4081 of 24/06/2016