Cosentyx
secukinumab
Table of contents
Overview
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 children above 6 years old who need treatment with a systemic medicine (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) in adults, including ankylosing spondylitis when X-ray shows the disease, and non-radiographic axial spondyloarthritis 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);
- hidradenitis suppurativa (acne inversa), a long-term skin disease that causes lumps, abscesses (collections of pus) and scarring on the skin, in adults. It is used to treat moderate-to-severe, active disease when conventional systemic treatments do not work well enough.
Cosentyx contains the active substance secukinumab.
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List item
Cosentyx : EPAR - Medicine overview (PDF/162.24 KB)
First published: 02/03/2015
Last updated: 03/06/2023
EMA/250862/2023 -
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List item
Cosentyx : EPAR - Risk-management-plan summary (PDF/75.89 KB)
First published: 02/03/2015
Last updated: 02/06/2023
Authorisation details
Product details | |
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Name |
Cosentyx
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Agency product number |
EMEA/H/C/003729
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Active substance |
Secukinumab
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International non-proprietary name (INN) or common name |
secukinumab
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Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
L04AC10
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Publication details | |
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Marketing-authorisation holder |
Novartis Europharm Limited
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Revision |
34
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Date of issue of marketing authorisation valid throughout the European Union |
14/01/2015
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Contact address |
Vista Building |
Product information
29/08/2023 Cosentyx - EMEA/H/C/003729 - IAIN/0103/G
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
Plaque psoriasis
Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults and children from the age of 6 years old who are candidates for systemic therapy.
Hidradenitis suppurativa (HS)
Cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy.
Psoriatic arthritis
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).
Juvenile idiopathic arthritis (JIA)
Enthesitis-related arthritis (ERA)
Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.
Juvenile psoriatic arthritis (JPsA)
Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.
Assessment history
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 - 26 April 202326/04/2023
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20/05/2022
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26/06/2020
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27/03/2020
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 October 201523/10/2015
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21/11/2014