Nuedexta

RSS

dextromethorphan hydrobromide / quinidine sulfate

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Nuedexta has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 11/03/2016

Authorisation details

Product details
Name
Nuedexta
Agency product number
EMEA/H/C/002560
Active substance
  • dextromethorphan
  • quinidine
International non-proprietary name (INN) or common name
dextromethorphan hydrobromide / quinidine sulfate
Therapeutic area (MeSH)
Neurobehavioral Manifestations
Anatomical therapeutic chemical (ATC) code
N07XX59
Publication details
Marketing-authorisation holder
Jenson Pharmaceutical Services Limited
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
24/06/2013
Contact address
Carradine House
237 Regents Park Road
London
N3 3LF
United Kingdom

Product information

24/10/2014 Nuedexta - EMEA/H/C/002560 - IAIN/0005

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

Other nervous system drugs

Therapeutic indication

Nuedexta is indicated for the symptomatic treatment of pseudobulbar affect (PBA) in adults. Efficacy has only been studied in patients with underlying amyotrophic lateral sclerosis or multiple sclerosis.

Assessment history

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