Ongentys (opicapone)
- Region
- 🇪🇺 EU
- Active substance
- opicapone
- Company
- Bial - Portela Cª, S.A.
- Status
- Authorised
- Therapeutic area
- Parkinson Disease
- CHMP opinion
- Thu 28 Apr 2016
- EU approval
- Fri 24 Jun 2016
- Application
- EMEA/H/C/002790
- ATC
- N04
- Official record
- www.ema.europa.eu
Indication
Ongentys 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.Ongentys 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
- 🇪🇺 Ontilyv Lapsed · Bial Portela & Companhia 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.