Skilarence
dimethyl fumarate
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Skilarence. 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 Skilarence.
For practical information about using Skilarence, patients should read the package leaflet or contact their doctor or pharmacist.
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Skilarence : EPAR - Summary for the public (PDF/75.7 KB)
First published: 11/07/2017
Last updated: 27/09/2017 -
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Skilarence : EPAR - Risk management plan summary (PDF/157.01 KB)
First published: 08/03/2022
Authorisation details
Product details | |
---|---|
Name |
Skilarence
|
Agency product number |
EMEA/H/C/002157
|
Active substance |
dimethyl fumarate
|
International non-proprietary name (INN) or common name |
dimethyl fumarate
|
Therapeutic area (MeSH) |
Psoriasis
|
Anatomical therapeutic chemical (ATC) code |
L04AX07
|
Publication details | |
---|---|
Marketing-authorisation holder |
Almirall S.A
|
Revision |
11
|
Date of issue of marketing authorisation valid throughout the European Union |
23/06/2017
|
Contact address |
Ronda General Mitre
151 08022 Barcelona Spain |
Product information
22/09/2022 Skilarence - EMEA/H/C/002157 - N/0031
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
Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.