Tremfya

RSS

guselkumab

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

Overview

Tremfya is a medicine used to treat moderate to severe plaque psoriasis (a disease causing red, scaly skin patches) when treatments applied to the skin are not suitable.

It is also used to treat psoriatic arthritis (scaly skin patches with joint inflammation) alone or with another medicine called methotrexate. For psoriatic arthritis, Tremfya is used when medicines to treat the underlying inflammation (disease-modifying medicines) have not worked well enough or when the patient cannot take these medicines.

Tremfya contains the active substance guselkumab.

This EPAR was last updated on 22/07/2022

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
Publication details
Marketing-authorisation holder
Janssen-Cilag International NV
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
10/11/2017
Contact address

Turnhoutseweg 30
B-2340 Beerse
Belgium

Product information

15/07/2022 Tremfya - EMEA/H/C/004271 - R/0033

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Product information documents contain:

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

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

Psoriatic arthritis

Tremfya, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy (see section 5.1).

Assessment history

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