Leganto (rotigotine)
- Region
- 🇪🇺 EU
- Active substance
- rotigotine
- Company
- UCB Pharma S.A.
- Status
- Withdrawn
- Therapeutic area
- Restless Legs Syndrome; Parkinson Disease
- CHMP opinion
- Thu 14 Apr 2011
- EU approval
- Thu 16 Jun 2011
- Application
- EMEA/H/C/002380
- ATC
- N04BC09
- Official record
- www.ema.europa.eu
Indication
Leganto is indicated for the symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in adults. Leganto is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or ‘on-off’ fluctuations).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Neupro Authorised · UCB Pharma S.A.
- 🇪🇺 Rotigotine Mylan Application withdrawn · Mylan S.A.S
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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.