Cimzia

RSS

certolizumab pegol

Authorised
This medicine is authorised for use in the European Union.

Overview

An overview of Cimzia and why it is authorised in the EU

Cimzia is a medicine that is used in adults to treat the following diseases:

  • active rheumatoid arthritis (a disease causing inflammation of the joints) when it is used in combination with another medicine, methotrexate, or given alone when treatment with methotrexate is not appropriate.
  • axial spondyloarthritis (a disease causing inflammation and pain in the joints of the spine), including ankylosing spondylitis and when the X-ray does not show disease but there are clear signs of inflammation.
  • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints) when it is used in combination with methotrexate or given alone when treatment with methotrexate is not appropriate.
  • plaque psoriasis, a disease causing red, scaly patches on the skin.

Cimzia is mostly used for conditions that are severe, moderately severe or getting worse, or when patients cannot use other treatments. For detailed information on the use of Cimzia in all conditions, see the summary of product characteristics.

Cimzia contains the active substance certolizumab pegol.

This EPAR was last updated on 20/09/2018

Authorisation details

Product details
Name
Cimzia
Agency product number
EMEA/H/C/001037
Active substance
Certolizumab pegol
International non-proprietary name (INN) or common name
certolizumab pegol
Therapeutic area (MeSH)
Arthritis, Rheumatoid
Anatomical therapeutic chemical (ATC) code
L04AB05
Publication details
Marketing-authorisation holder
UCB Pharma SA 
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
30/09/2009
Contact address
UCB Pharma SA
Allée de la Recherche 60
B-1070 Bruxelles
Belgium

Product information

19/07/2018 Cimzia - EMEA/H/C/001037 - II/0068/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Immunosuppressants

Therapeutic 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 MTX, has been inadequate. Cimzia can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate
  • the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.

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 MTX.

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 C reactive protein (CRP) and /or magnetic resonance imaging (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.

Assessment history

Changes since initial authorisation of medicine

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