Cimzia
certolizumab pegol
Table of contents
Overview
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.
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List item
Cimzia : EPAR - Medicine overview (PDF/110.12 KB)
First published: 22/10/2009
Last updated: 24/07/2019
EMA/409425/2019 -
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List item
Cimzia : EPAR - Risk-management-plan summary (PDF/1.04 MB)
First published: 11/02/2019
Last updated: 08/07/2021
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 |
34
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Date of issue of marketing authorisation valid throughout the European Union |
01/10/2009
|
Contact address |
UCB Pharma SA
Allée de la Recherche 60 B-1070 Bruxelles Belgium |
Product information
26/04/2023 Cimzia - EMEA/H/C/001037 - N/0107
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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
News
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27/04/2018
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20/11/2015
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 October 201325/10/2013
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20/09/2013