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Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Levodopa/Carbidopa/Entacapone Orion   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Levodopa/Carbidopa/Entacapona Orion (PT)
Auth. number : EU/1/11/706
INN : Levodopa,carbidopa,entacapone
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N04 - Anti-parkinson drugs
Pharmacological subgroup: N04B - Dopaminergic agents
Chemical subgroup: N04BA - Dopa and dopa derivatives
Chemical substance: N04BA03 - Levodopa, decarboxylase inhibitor and COMT inhibitor
(See WHO ATC Index)
Indication: Levodopa/Carbidopa/Entacapone Orion 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.
Marketing Authorisation Holder: Orion Corporation
Orionintie 1, FI-02200 Espoo, Suomi

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
29/08/2011 Centralised - Authorisation EMEA/H/C/2441 (2011)6139 of 24/08/2011
17/01/2013 Centralised - Variation EMEA/H/C/2441/WS/331 (2013)208 of 14/01/2013
01/07/2013 Centralised - Variation EMEA/H/C/2441/X/3 (2013)4189 of 27/06/2013
14/08/2013 Centralised - Notification EMEA/H/C/2441/N/8
30/06/2014 Centralised - Notification EMEA/H/C/2441/N/12