Neofordex

RSS

dexamethasone

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

Overview

This is a summary of the European public assessment report (EPAR) for Neofordex. 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 Neofordex.

For practical information about using Neofordex, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 12/06/2018

Authorisation details

Product details
Name
Neofordex
Agency product number
EMEA/H/C/004071
Active substance
dexamethasone
International non-proprietary name (INN) or common name
dexamethasone
Therapeutic area (MeSH)
Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
H02AB02
Publication details
Marketing-authorisation holder
Laboratoires CTRS 
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
16/03/2016
Contact address
Laboratoires CTRS
63 rue de l’Est
92100 Boulogne Billancourt
France

Product information

28/05/2018 Neofordex - EMEA/H/C/004071 - IAIN/0007

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

CORTICOSTEROIDS FOR SYSTEMIC USE

Therapeutic indication

Treatment of multiple myeloma.

Assessment history

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