Skilarence

RSS

dimethyl fumarate

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

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.

This EPAR was last updated on 27/09/2022

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

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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

dimethyl fumarate

Therapeutic indication

Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.

Assessment history

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