dextromethorphan hydrobromide / quinidine sulfate
The marketing authorisation for Nuedexta has been withdrawn at the request of the marketing-authorisation holder.
Nuedexta : EPAR - Summary for the public (PDF/193.76 KB)
First published: 02/07/2013
Last updated: 02/07/2013
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Jenson Pharmaceutical Services Limited
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237 Regents Park Road
24/10/2014 Nuedexta - EMEA/H/C/002560 - IAIN/0005
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Other nervous system drugs
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.