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 11/07/2018

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
-
Publication details
Marketing-authorisation holder
Almirall S.A
Revision
1
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

20/06/2018 Skilarence - EMEA/H/C/002157 - IAIN/0006

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

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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