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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Entacapone Orion   

   This product is authorised under a different brand name in the EU in the following languages:
   - Entacapona Orion (PT)
Auth. number : EU/1/11/708
Active substance : entacapone
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N04 - Anti-parkinson drugs
Pharmacological subgroup: N04B - Dopaminergic agents
Chemical subgroup: N04BX - Other dopaminergic agents
Chemical substance: N04BX02 - entacapone
(See WHO ATC Index)
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.
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
22/08/2011 Centralised - Authorisation EMEA/H/C/2440 (2011)6046 of 18/08/2011
20/03/2012 Centralised - Notification EMEA/H/C/2440/N/3
Updated with Decision(2013)216 of 14/01/2013
13/07/2012 Centralised - Notification EMEA/H/C/2440/N/4
Updated with Decision(2013)216 of 14/01/2013
17/01/2013 Centralised - Variation EMEA/H/C/2440/IB/WS/331 (2013)216 of 14/01/2013
19/08/2013 Centralised - Notification EMEA/H/C/2440/N/6
Updated with Decision(2016)453 of 25/01/2016
22/01/2015 Centralised - Variation EMEA/H/C/2440/WS/665
Updated with Decision(2016)453 of 25/01/2016
29/09/2015 Centralised - Notification EMEA/H/C/2440/N/10
Updated with Decision(2016)453 of 25/01/2016
27/01/2016 Centralised - Yearly update (2016)453 of 25/01/2016
12/04/2016 Centralised - Renewal EMEA/H/C/2440/R/11 (2016)2193 of 08/04/2016
15/12/2016 Centralised - Variation EMEA/H/C/2440/WS/1064
Updated with Decision(2017)8502 of 28/11/2017
30/11/2017 Centralised - Yearly update (2017)8502 of 28/11/2017