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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Levodopa/Carbidopa/Entacapone Orion   

   This product is authorised under a different brand name in the EU in the following languages:
   - Levodopa/Carbidopa/Entacapona Orion (PT)
Auth. number : EU/1/11/706
Active substance : 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, 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
Updated with Decision(2016)410 of 22/01/2016
30/06/2014 Centralised - Notification EMEA/H/C/2441/N/12
Updated with Decision(2016)410 of 22/01/2016
22/01/2015 Centralised - Variation EMEA/H/C/2441/WS/665
Updated with Decision(2016)410 of 22/01/2016
02/06/2015 Centralised - Notification EMEA/H/C/2441/N/16
Updated with Decision(2016)410 of 22/01/2016
26/01/2016 Centralised - Yearly update (2016)410 of 22/01/2016
30/05/2016 Centralised - Renewal EMEA/H/C/2441/R/19 (2016)3307 of 26/05/2016
08/02/2018 Centralised - Variation EMEA/H/C/2441/WS/1327