EMA — authorised 17 October 2010
- Marketing authorisation holder: Orion Corporation
- Status: approved
🇪🇺 Sinemet Cr in European Union
EMA authorised Sinemet Cr on 17 October 2010
Marketing authorisations
EMA — authorised 11 November 2013
- Application: EMEA/H/C/002785
- Marketing authorisation holder: Orion Corporation
- Local brand name: Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz)
- Indication: Corbilta is indicated for the treatment of adult patients with Parkinson’s disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.
- Status: approved
Sinemet Cr in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in European Union
Frequently asked questions
Is Sinemet Cr approved in European Union?
Yes. EMA authorised it on 17 October 2010; EMA authorised it on 11 November 2013.
Who is the marketing authorisation holder for Sinemet Cr in European Union?
Orion Corporation holds the EU marketing authorisation.