Kyntheum

RSS

brodalumab

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

Overview

This is a summary of the European public assessment report (EPAR) for Kyntheum. 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 Kyntheum.

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

This EPAR was last updated on 13/11/2019

Authorisation details

Product details
Name
Kyntheum
Agency product number
EMEA/H/C/003959
Active substance
brodalumab
International non-proprietary name (INN) or common name
brodalumab
Therapeutic area (MeSH)
Psoriasis
Anatomical therapeutic chemical (ATC) code
L04AC12
Additional monitoringAdditional 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
LEO Pharma A/S
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
17/07/2017
Contact address
Industriparken 55
DK-2750 Ballerup
Denmark

Product information

26/09/2019 Kyntheum - EMEA/H/C/003959 - II/0011

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Kyntheum is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.

Assessment history

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