🇪🇺 Comtan® in European Union

EMA authorised Comtan® on 18 February 2011

Marketing authorisations

EMA — authorised 18 February 2011

  • Application: EMEA/H/C/002075
  • Marketing authorisation holder: Teva Pharma B.V.
  • Local brand name: Entacapone Teva
  • Indication: Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use 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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EMA — authorised 18 August 2011

  • Application: EMEA/H/C/002440
  • Marketing authorisation holder: Orion Corporation
  • Local brand name: Entacapone Orion
  • Indication: Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
  • Status: approved

Read official source →

Comtan® in other countries

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

Frequently asked questions

Is Comtan® approved in European Union?

Yes. EMA authorised it on 18 February 2011; EMA authorised it on 18 August 2011.

Who is the marketing authorisation holder for Comtan® in European Union?

Teva Pharma B.V. holds the EU marketing authorisation.