Nuedexta

RSS
Withdrawn

This medicine's authorisation has been withdrawn

dextromethorphan hydrobromide / quinidine sulfate
Medicine Human Withdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 15 February 2016 the European Commission withdrew the marketing authorisation for Nuedexta (dextromethorphan / quinidine) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Jenson Pharmaceutical Services Ltd, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Nuedexta was granted marketing authorisation in the EU on 24 June 2013 for treatment of pseudobulbar affect (PBA) in adults. The product had not been marketed in the EU. 

The European Public Assessment Report (EPAR) for Nuedexta is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Nuedexta : EPAR - Summary for the public

Reference Number: EMA/367786/2013

English (EN) (193.76 KB - PDF)

First published: Last updated:
View

български (BG) (312.89 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

español (ES) (266.25 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

čeština (CS) (293.48 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

dansk (DA) (266.6 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

Deutsch (DE) (267.83 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

eesti keel (ET) (269.56 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

ελληνικά (EL) (320.31 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

français (FR) (267.84 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

hrvatski (HR) (283.73 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

italiano (IT) (264.25 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

latviešu valoda (LV) (302.74 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

lietuvių kalba (LT) (283 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

magyar (HU) (284.97 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

Malti (MT) (290.76 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

Nederlands (NL) (264.69 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

polski (PL) (284.4 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

português (PT) (286.28 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

română (RO) (268.86 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

slovenčina (SK) (285.42 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

slovenščina (SL) (286.75 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

Suomi (FI) (262.95 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

svenska (SV) (265.02 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

Product information

Nuedexta : EPAR - Product Information

English (EN) (635.09 KB - PDF)

First published: Last updated:
View

български (BG) (1.24 MB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View

español (ES) (638.47 KB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View

čeština (CS) (994 KB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View

dansk (DA) (630.24 KB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View

Deutsch (DE) (690.2 KB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View

eesti keel (ET) (627.09 KB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View

ελληνικά (EL) (1.36 MB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View

français (FR) (691.37 KB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View

hrvatski (HR) (642.16 KB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View

íslenska (IS) (955.72 KB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View

italiano (IT) (651.76 KB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View

latviešu valoda (LV) (994.32 KB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View

lietuvių kalba (LT) (810.7 KB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View

magyar (HU) (994.57 KB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View

Malti (MT) (1.04 MB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View

Nederlands (NL) (663.87 KB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View

norsk (NO) (943.33 KB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View

polski (PL) (1.71 MB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View

português (PT) (649.06 KB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View

română (RO) (655.52 KB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View

slovenčina (SK) (976.88 KB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View

slovenščina (SL) (925.24 KB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View

Suomi (FI) (653.71 KB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View

svenska (SV) (642.3 KB - PDF)

First published: 02/07/2013 Last updated: 26/11/2014
View
Latest procedure affecting product information:IAIN/0005
24/10/2014
icon globe

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Nuedexta : EPAR - All Authorised presentations

English (EN) (159.57 KB - PDF)

First published: Last updated:
View

български (BG) (167.05 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

español (ES) (153.71 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

čeština (CS) (160.1 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

dansk (DA) (154.47 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

Deutsch (DE) (154.57 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

eesti keel (ET) (153.66 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

ελληνικά (EL) (177.22 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

français (FR) (153.69 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

hrvatski (HR) (282.98 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

íslenska (IS) (169.64 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

italiano (IT) (152.66 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

latviešu valoda (LV) (164.45 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

lietuvių kalba (LT) (154.89 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

magyar (HU) (160.64 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

Malti (MT) (160.78 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

Nederlands (NL) (153.75 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

norsk (NO) (170.1 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

polski (PL) (159.71 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

português (PT) (154.08 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

română (RO) (153.69 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

slovenčina (SK) (159.39 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

slovenščina (SL) (157.93 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

Suomi (FI) (152.94 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

svenska (SV) (136.89 KB - PDF)

First published: 02/07/2013 Last updated: 02/07/2013
View

Product details

Name of medicine
Nuedexta
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

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.

Authorisation details

EMA product number
EMEA/H/C/002560
Marketing authorisation holder
Jenson Pharmaceutical Services Limited

Carradine House
237 Regents Park Road
London
N3 3LF
United Kingdom

Marketing authorisation issued
24/06/2013
Withdrawal of marketing authorisation
15/02/2016
Revision
2

Assessment history

Nuedexta : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (204.51 KB - PDF)

First published: Last updated:
View

Nuedexta : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/80029/2013

English (EN) (2.11 MB - PDF)

First published: Last updated:
View

CHMP summary of positive opinion for Nuedexta

Adopted Reference Number: EMA/CHMP/132029/2013

English (EN) (244.66 KB - PDF)

First published: Last updated:
View
This page was last updated on

Share this page

Back to top