🇪🇺 Ongentys in European Union

EMA authorised Ongentys on 24 June 2016

Marketing authorisation

EMA — authorised 24 June 2016

  • Application: EMEA/H/C/002790
  • Marketing authorisation holder: Bial - Portela Cª, S.A.
  • Local brand name: Ongentys
  • 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.
  • Status: approved

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Ongentys in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Neuroscience approved in European Union

Frequently asked questions

Is Ongentys approved in European Union?

Yes. EMA authorised it on 24 June 2016.

Who is the marketing authorisation holder for Ongentys in European Union?

Bial - Portela Cª, S.A. holds the EU marketing authorisation.