Nuedexta (dextromethorphan hydrobromide;quinidine sulfate)
- Region
- 🇪🇺 EU
- Active substance
- dextromethorphan hydrobromide;quinidine sulfate
- Company
- Jenson Pharmaceutical Services Limited
- Status
- Withdrawn
- Therapeutic area
- Neurobehavioral Manifestations
- EU approval
- Mon 24 Jun 2013
- Application
- EMEA/H/C/002560
- ATC
- N07XX59
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.