Nordimet

RSS

methotrexate

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

Overview

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.

This EPAR was last updated on 15/06/2018

Authorisation details

Product details
Name
Nordimet
Agency product number
EMEA/H/C/003983
Active substance
Methotrexate
International non-proprietary name (INN) or common name
methotrexate
Therapeutic area (MeSH)
  • Arthritis, Psoriatic
  • Psoriasis
  • Arthritis, Juvenile Rheumatoid
  • Arthritis, Rheumatoid
Anatomical therapeutic chemical (ATC) code
L04AX03
Publication details
Marketing-authorisation holder
Nordic Group B.V.
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
18/08/2016
Contact address
Siriusdreef 22
NL-2132 WT Hoofddorp
The Netherlands

Product information

16/05/2018 Nordimet - EMEA/H/C/003983 - PSUSA/00002014/201706

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

ANTINEOPLASTIC AGENTS

Therapeutic indication

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.

Assessment history

How useful was this page?

Add your rating