Nuedexta
Withdrawn
This medicine's authorisation has been withdrawn
dextromethorphan hydrobromide / quinidine sulfate
MedicineHumanWithdrawn
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- 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Assessment Report (EPAR) for Nuedexta is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:IAIN/0005
24/10/2014
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).
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 drugsTherapeutic 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.
News on Nuedexta
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