Nuedexta

dextromethorphan hydrobromide / quinidine sulfate

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The marketing authorisation for Nuedexta has been withdrawn at the request of the marketing-authorisation holder.

Name Language First published Last updated
Nuedexta : EPAR - Summary for the public BG = bălgarski 02/07/2013  
Nuedexta : EPAR - Summary for the public ES = español 02/07/2013  
Nuedexta : EPAR - Summary for the public CS = čeština 02/07/2013  
Nuedexta : EPAR - Summary for the public DA = dansk 02/07/2013  
Nuedexta : EPAR - Summary for the public DE = Deutsch 02/07/2013  
Nuedexta : EPAR - Summary for the public ET = eesti keel 02/07/2013  
Nuedexta : EPAR - Summary for the public EL = elliniká 02/07/2013  
Nuedexta : EPAR - Summary for the public EN = English 02/07/2013  
Nuedexta : EPAR - Summary for the public FR = français 02/07/2013  
Nuedexta : EPAR - Summary for the public IT = italiano 02/07/2013  
Nuedexta : EPAR - Summary for the public LV = latviešu valoda 02/07/2013  
Nuedexta : EPAR - Summary for the public LT = lietuvių kalba 02/07/2013  
Nuedexta : EPAR - Summary for the public HU = magyar 02/07/2013  
Nuedexta : EPAR - Summary for the public MT = Malti 02/07/2013  
Nuedexta : EPAR - Summary for the public NL = Nederlands 02/07/2013  
Nuedexta : EPAR - Summary for the public PL = polski 02/07/2013  
Nuedexta : EPAR - Summary for the public PT = português 02/07/2013  
Nuedexta : EPAR - Summary for the public RO = română 02/07/2013  
Nuedexta : EPAR - Summary for the public SK = slovenčina 02/07/2013  
Nuedexta : EPAR - Summary for the public SL = slovenščina 02/07/2013  
Nuedexta : EPAR - Summary for the public FI = suomi 02/07/2013  
Nuedexta : EPAR - Summary for the public SV = svenska 02/07/2013  
Nuedexta : EPAR - Summary for the public HR = Hrvatski 02/07/2013  

This EPAR was last updated on 11/03/2016 .

Authorisation details

Product details

Product details for Nuedexta
NameNuedexta
Agency product numberEMEA/H/C/002560
Active substance

dextromethorphan / quinidine

International non-proprietary name (INN) or common name

dextromethorphan hydrobromide / quinidine sulfate

Therapeutic area Neurobehavioral Manifestations
Anatomical therapeutic chemical (ATC) code N07XX59

Publication details

Publication details for Nuedexta
Marketing-authorisation holder

Jenson Pharmaceutical Services Limited

Revision2
Date of issue of marketing authorisation valid throughout the European Union24/06/2013

Contact address:

Jenson Pharmaceutical Services Limited
Carradine House
237 Regents Park Road
London
N3 3LF
United Kingdom

Product information

Product information

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

Name Language First published Last updated
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014
Nuedexta : EPAR - Product Information HR = Hrvatski 02/07/2013 26/11/2014

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.


Name Language First published Last updated
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Nuedexta : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Nuedexta : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 13/08/2014 26/11/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Nuedexta : EPAR - Public assessment report HR = Hrvatski 02/07/2013  
CHMP summary of positive opinion for Nuedexta HR = Hrvatski 26/04/2013  

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Nuedexta