Nuedexta
dextromethorphan hydrobromide / quinidine sulfate
Table of contents
Overview
The marketing authorisation for Nuedexta has been withdrawn at the request of the marketing-authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Nuedexta
|
| Agency product number |
EMEA/H/C/002560
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
|
| Therapeutic area (MeSH) |
Neurobehavioral Manifestations
|
| Anatomical therapeutic chemical (ATC) code |
N07XX59
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Jenson Pharmaceutical Services Limited
|
| Revision |
2
|
| Date of issue of marketing authorisation valid throughout the European Union |
24/06/2013
|
| Contact address |
Carradine House
237 Regents Park Road London N3 3LF United Kingdom |
Product information
24/10/2014 Nuedexta - EMEA/H/C/002560 - IAIN/0005
This medicine’s product information is available in all official EU languages.
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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.
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.