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Active Substance: dextromethorphan / quinidine
Common Name: dextromethorphan hydrobromide / quinidine sulfate
ATC Code: N07XX59
Marketing Authorisation Holder: Jenson Pharmaceutical Services Limited
Active Substance: dextromethorphan / quinidine
Status: Withdrawn
Authorisation Date: 2013-06-24
Therapeutic Area: Neurobehavioral Manifestations
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.

The marketing authorisation for Nuedexta has been withdrawn at the request of the marketing-authorisation holder.

Source: European Medicines Agency

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