Nuedexta

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Withdrawn

This medicine's authorisation has been withdrawn

dextromethorphan hydrobromide / quinidine sulfate
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Nuedexta has been withdrawn at the request of the marketing-authorisation holder.

Nuedexta : EPAR - Summary for the public

Reference Number: EMA/367786/2013

English (EN) (193.76 KB - PDF)

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български (BG) (312.89 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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español (ES) (266.25 KB - PDF)

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čeština (CS) (293.48 KB - PDF)

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dansk (DA) (266.6 KB - PDF)

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Deutsch (DE) (267.83 KB - PDF)

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eesti keel (ET) (269.56 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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ελληνικά (EL) (320.31 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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français (FR) (267.84 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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hrvatski (HR) (283.73 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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italiano (IT) (264.25 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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latviešu valoda (LV) (302.74 KB - PDF)

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lietuvių kalba (LT) (283 KB - PDF)

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magyar (HU) (284.97 KB - PDF)

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Malti (MT) (290.76 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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Nederlands (NL) (264.69 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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polski (PL) (284.4 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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português (PT) (286.28 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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română (RO) (268.86 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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slovenčina (SK) (285.42 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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slovenščina (SL) (286.75 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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Suomi (FI) (262.95 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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svenska (SV) (265.02 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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Product information

Nuedexta : EPAR - Product Information

English (EN) (635.09 KB - PDF)

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български (BG) (1.24 MB - PDF)

First published: 02/07/2013Last updated: 26/11/2014
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español (ES) (638.47 KB - PDF)

First published: 02/07/2013Last updated: 26/11/2014
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čeština (CS) (994 KB - PDF)

First published: 02/07/2013Last updated: 26/11/2014
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dansk (DA) (630.24 KB - PDF)

First published: 02/07/2013Last updated: 26/11/2014
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Deutsch (DE) (690.2 KB - PDF)

First published: 02/07/2013Last updated: 26/11/2014
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eesti keel (ET) (627.09 KB - PDF)

First published: 02/07/2013Last updated: 26/11/2014
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ελληνικά (EL) (1.36 MB - PDF)

First published: 02/07/2013Last updated: 26/11/2014
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français (FR) (691.37 KB - PDF)

First published: 02/07/2013Last updated: 26/11/2014
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hrvatski (HR) (642.16 KB - PDF)

First published: 02/07/2013Last updated: 26/11/2014
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íslenska (IS) (955.72 KB - PDF)

First published: 02/07/2013Last updated: 26/11/2014
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italiano (IT) (651.76 KB - PDF)

First published: 02/07/2013Last updated: 26/11/2014
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latviešu valoda (LV) (994.32 KB - PDF)

First published: 02/07/2013Last updated: 26/11/2014
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lietuvių kalba (LT) (810.7 KB - PDF)

First published: 02/07/2013Last updated: 26/11/2014
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magyar (HU) (994.57 KB - PDF)

First published: 02/07/2013Last updated: 26/11/2014
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Malti (MT) (1.04 MB - PDF)

First published: 02/07/2013Last updated: 26/11/2014
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Nederlands (NL) (663.87 KB - PDF)

First published: 02/07/2013Last updated: 26/11/2014
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norsk (NO) (943.33 KB - PDF)

First published: 02/07/2013Last updated: 26/11/2014
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polski (PL) (1.71 MB - PDF)

First published: 02/07/2013Last updated: 26/11/2014
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português (PT) (649.06 KB - PDF)

First published: 02/07/2013Last updated: 26/11/2014
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română (RO) (655.52 KB - PDF)

First published: 02/07/2013Last updated: 26/11/2014
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slovenčina (SK) (976.88 KB - PDF)

First published: 02/07/2013Last updated: 26/11/2014
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slovenščina (SL) (925.24 KB - PDF)

First published: 02/07/2013Last updated: 26/11/2014
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Suomi (FI) (653.71 KB - PDF)

First published: 02/07/2013Last updated: 26/11/2014
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svenska (SV) (642.3 KB - PDF)

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

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български (BG) (167.05 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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español (ES) (153.71 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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čeština (CS) (160.1 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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dansk (DA) (154.47 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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Deutsch (DE) (154.57 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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eesti keel (ET) (153.66 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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ελληνικά (EL) (177.22 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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français (FR) (153.69 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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hrvatski (HR) (282.98 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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íslenska (IS) (169.64 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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italiano (IT) (152.66 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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latviešu valoda (LV) (164.45 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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lietuvių kalba (LT) (154.89 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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magyar (HU) (160.64 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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Malti (MT) (160.78 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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Nederlands (NL) (153.75 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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norsk (NO) (170.1 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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polski (PL) (159.71 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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português (PT) (154.08 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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română (RO) (153.69 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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slovenčina (SK) (159.39 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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slovenščina (SL) (157.93 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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Suomi (FI) (152.94 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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svenska (SV) (136.89 KB - PDF)

First published: 02/07/2013Last updated: 02/07/2013
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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
Revision
2

Assessment history

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

English (EN) (204.51 KB - PDF)

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Nuedexta : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/80029/2013

English (EN) (2.11 MB - PDF)

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CHMP summary of positive opinion for Nuedexta

AdoptedReference Number: EMA/CHMP/132029/2013

English (EN) (244.66 KB - PDF)

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More information on Nuedexta

Public statement on Nuedexta: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/186479/2016

English (EN) (57.57 KB - PDF)

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