Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Cimzia   
Auth. number : EU/1/09/544
INN : certolizumab pegol
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: L04AB05 - Certolizumab pegol
(See WHO ATC Index)
Indication: Rheumatoid arthritis
Cimzia, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate, has been inadequate.
Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Cimzia 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.
Axial spondyloarthritis
Cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising:
Ankylosing spondylitis (AS)
Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
Axial spondyloarthritis without radiographic evidence of AS
Adults with severe active 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 NSAIDs.
Psoriatic arthritis
Cimzia, in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Marketing Authorisation Holder: UCB Pharma S.A.
Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

  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
29/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1037/II/1
05/10/2009 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/1037 (2009)7650 of 01/10/2009
06/10/2009 Centralised - Authorisation EMEA/H/C/1037 (2009)7651 of 01/10/2009
09/12/2009 Centralised - Notification EMEA/H/C/1037/N/2
Updated with Decision(2010)5999 of 26/08/2010
29/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1037/II/5
09/06/2010 Centralised - Variation (refusal) EMEA/H/C/1037/IA/7/G
27/08/2010 Centralised - Variation EMEA/H/C/1037/IA/8/G
Updated with Decision(2010)8635 of 29/11/2010
30/08/2010 Centralised - Variation EMEA/H/C/1037/II/6 (2010)5999 of 26/08/2010
02/12/2010 Centralised - Variation (2010)8635 of 29/11/2010
11/02/2011 Centralised - Variation EMEA/H/C/1037/II/9 (2011)920 of 09/02/2011
21/11/2011 Centralised - Variation EMEA/H/C/1037/IB/16
Updated with Decision(2012)4271 of 21/06/2012
20/06/2012 Centralised - Variation (2012)4271 of 21/06/2012
29/06/2012 Centralised - Variation EMEA/H/C/1037/II/17, 18, 20 (2012)4485 of 27/06/2012
08/10/2012 Centralised - Variation EMEA/H/C/1037/II/14/G (2012)7102 of 04/10/2012
13/12/2012 Centralised - Variation EMEA/H/C/1037/II/24
Updated with Decision(2013)7042 of 18/10/2013
21/03/2013 Centralised - Variation EMEA/H/C/1037/II/28
Updated with Decision(2013)7042 of 18/10/2013
25/04/2013 Centralised - Variation EMEA/H/C/1037/II/31
Updated with Decision(2013)7042 of 18/10/2013
12/08/2013 Centralised - Variation EMEA/H/C/1037/IB/33/G
Updated with Decision(2013)7042 of 18/10/2013
22/10/2013 Centralised - 2-Monthly update EMEA/H/C/1037/II/29 (2013)7042 of 18/10/2013
27/11/2013 Centralised - 2-Monthly update EMEA/H/C/1037/II/26, 27 (2013)8503 of 25/11/2013
20/05/2014 Centralised - Renewal EMEA/H/C/1037/R/40 (2014)3414 of 16/05/2014