Tremfya

RSS

guselkumab

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

Overview

Tremfya is a medicine that acts on the immune system and is used to treat plaque psoriasis, a disease causing red, scaly patches on the skin. It is used in adults with moderate to severe disease for whom treatments applied to the skin are not suitable. Tremfya contains the active substance guselkumab.

This EPAR was last updated on 05/06/2019

Authorisation details

Product details
Name
Tremfya
Agency product number
EMEA/H/C/004271
Active substance
guselkumab
International non-proprietary name (INN) or common name
guselkumab
Therapeutic area (MeSH)
Psoriasis
Anatomical therapeutic chemical (ATC) code
L04AC
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
Janssen-Cilag International N.V.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
10/11/2017
Contact address
Turnhoutseweg 30
B-2340 Beerse
Belgium

Product information

14/02/2019 Tremfya - EMEA/H/C/004271 - II/0005

Contents

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Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

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

Assessment history

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