Cosentyx

RSS

secukinumab

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

Overview

This is a summary of the European public assessment report (EPAR) for Cosentyx. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Cosentyx.

For practical information about using Cosentyx, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 01/10/2018

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
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
15/01/2015
Contact address
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

20/09/2018 Cosentyx - EMEA/H/C/003729 - PSUSA/00010341/201712

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

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.

Ankylosing spondylitis

Cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.

Assessment history

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