Ontilyv (opicapone)
- Region
- 🇪🇺 EU
- Active substance
- opicapone
- Company
- Bial Portela & Companhia S.A.
- Status
- Lapsed
- Therapeutic area
- Parkinson Disease
- CHMP opinion
- Thu 16 Dec 2021
- EU approval
- Mon 21 Feb 2022
- Application
- EMEA/H/C/005782
- ATC
- N04;N04BX04
- Official record
- www.ema.europa.eu
Indication
Ontilyv is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Ongentys Authorised · Bial - Portela Cª, S.A.
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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.