Tremfya
guselkumab
Table of contents
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.
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List item
Tremfya : EPAR - Medicine overview (PDF/96.54 KB)
First published: 30/11/2017
Last updated: 20/07/2022
EMA/555324/2018 -
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Tremfya : EPAR - Risk-management-plan summary (PDF/163.44 KB)
First published: 22/01/2021
Last updated: 09/03/2022
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
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Date of issue of marketing authorisation valid throughout the European Union |
10/11/2017
|
Contact address |
Turnhoutseweg 30 |
Product information
15/07/2022 Tremfya - EMEA/H/C/004271 - R/0033
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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).