This is a summary of the European public assessment report (EPAR) for Nordimet. 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 Nordimet.
For practical information about using Nordimet, patients should read the package leaflet or contact their doctor or pharmacist.
Nordimet : EPAR - Summary for the public (PDF/107.71 KB)
First published: 29/09/2016
Last updated: 29/09/2016
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Nordic Group B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
16/05/2018 Nordimet - EMEA/H/C/003983 - PSUSA/00002014/201706
- 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.
Nordimet is indicated for the treatment of:
- active rheumatoid arthritis in adult patients,
- polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate,
- severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, psoralens and ultraviolet A (PUVA), and retinoids, and severe psoriatic arthritis in adult patients.