Cosentyx is a medicine that acts on the immune system (the body’s natural defences) and is used to treat the following conditions:
- moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin) in adults and patients above 6 years old who need treatment with a medicine given by mouth or by injection;
- psoriatic arthritis (inflammation of the joints associated with psoriasis) in adults when disease-modifying anti-rheumatic drugs (DMARDs) do not work well enough;
- axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis, when X-ray shows the disease, and non-radiographic axial spondyloarthritis, in adults when there are clear signs of inflammation but X-ray does not show disease. It is used when conventional treatments do not work well enough.
- two types of juvenile idiopathic arthritis (a form of arthritis in children), enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA), in patients from 6 years of age when conventional therapy does not work well enough or is not tolerated; Cosentyx can be used on its own or in combination with methotrexate (a DMARD medicine).
Cosentyx contains the active substance secukinumab.
Cosentyx : EPAR - Medicine overview (PDF/158.08 KB)
First published: 02/03/2015
Last updated: 02/08/2022
Cosentyx : EPAR - Risk-management-plan summary (PDF/76.73 KB)
First published: 02/03/2015
Last updated: 24/06/2022
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Novartis Europharm Limited
|Date of issue of marketing authorisation valid throughout the European Union||
20/06/2022 Cosentyx - EMEA/H/C/003729 - II/0079
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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).
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Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease modifying anti rheumatic drug (DMARD) therapy has been inadequate.
Axial spondyloarthritis (axSpA)
Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
Cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.
Non-radiographic axial spondyloarthritis (nr-axSpA)
Cosentyx is indicated for the treatment of 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 in adults who have responded inadequately to non-steroidal anti-inflammatory drugs (NSAIDs).
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2020 (updated)27/03/2020
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 October 201523/10/2015
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 November 201421/11/2014