Cosentyx

RSS

secukinumab

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

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 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.

Cosentyx contains the active substance secukinumab.

This EPAR was last updated on 06/09/2021

Authorisation details

Product details
Name
Cosentyx
Agency product number
EMEA/H/C/003729
Active substance
Secukinumab
International non-proprietary name (INN) or common name
secukinumab
Therapeutic area (MeSH)
  • Arthritis, Psoriatic
  • Psoriasis
  • Spondylitis, Ankylosing
Anatomical therapeutic chemical (ATC) code
L04AC10
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
14/01/2015
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

03/08/2021 Cosentyx - EMEA/H/C/003729 - IAIN/0081

Contents

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

Plaque psoriasis

Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic 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).

Assessment history

Changes since initial authorisation of medicine

Related content

How useful was this page?

Add your rating
Average
1 rating
1 rating