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The marketing authorisation for Nuedexta has been withdrawn at the request of the marketing-authorisation holder.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

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ελληνικά (EL) (320.31 KB - PDF)

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français (FR) (267.84 KB - PDF)

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română (RO) (268.86 KB - PDF)

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Suomi (FI) (262.95 KB - PDF)

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svenska (SV) (265.02 KB - PDF)

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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)

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español (ES) (638.47 KB - PDF)

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čeština (CS) (994 KB - PDF)

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dansk (DA) (630.24 KB - PDF)

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Deutsch (DE) (690.2 KB - PDF)

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eesti keel (ET) (627.09 KB - PDF)

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ελληνικά (EL) (1.36 MB - PDF)

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français (FR) (691.37 KB - PDF)

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hrvatski (HR) (642.16 KB - PDF)

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íslenska (IS) (955.72 KB - PDF)

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italiano (IT) (651.76 KB - PDF)

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latviešu valoda (LV) (994.32 KB - PDF)

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lietuvių kalba (LT) (810.7 KB - PDF)

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magyar (HU) (994.57 KB - PDF)

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Malti (MT) (1.04 MB - PDF)

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Nederlands (NL) (663.87 KB - PDF)

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norsk (NO) (943.33 KB - PDF)

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polski (PL) (1.71 MB - PDF)

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português (PT) (649.06 KB - PDF)

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română (RO) (655.52 KB - PDF)

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slovenčina (SK) (976.88 KB - PDF)

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slovenščina (SL) (925.24 KB - PDF)

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Suomi (FI) (653.71 KB - PDF)

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svenska (SV) (642.3 KB - PDF)

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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)

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español (ES) (153.71 KB - PDF)

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čeština (CS) (160.1 KB - PDF)

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dansk (DA) (154.47 KB - PDF)

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Deutsch (DE) (154.57 KB - PDF)

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eesti keel (ET) (153.66 KB - PDF)

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ελληνικά (EL) (177.22 KB - PDF)

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français (FR) (153.69 KB - PDF)

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hrvatski (HR) (282.98 KB - PDF)

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íslenska (IS) (169.64 KB - PDF)

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italiano (IT) (152.66 KB - PDF)

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latviešu valoda (LV) (164.45 KB - PDF)

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lietuvių kalba (LT) (154.89 KB - PDF)

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magyar (HU) (160.64 KB - PDF)

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Malti (MT) (160.78 KB - PDF)

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Nederlands (NL) (153.75 KB - PDF)

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norsk (NO) (170.1 KB - PDF)

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polski (PL) (159.71 KB - PDF)

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português (PT) (154.08 KB - PDF)

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română (RO) (153.69 KB - PDF)

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slovenčina (SK) (159.39 KB - PDF)

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slovenščina (SL) (157.93 KB - PDF)

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Suomi (FI) (152.94 KB - PDF)

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svenska (SV) (136.89 KB - PDF)

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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

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