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Community register of medicinal products for human use


Product information

Invented name: Entacapone Teva   
Auth. number : EU/1/10/665
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: 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: Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland
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
22/02/2011 Centralised - Authorisation EMEA/H/C/2075 (2011)1150 of 18/02/2011
02/02/2012 Centralised - Variation EMEA/H/C/2075/IA/2
Updated with Decision(2012)6388 of 10/09/2012
12/09/2012 Centralised - Variation (2012)6388 of 10/09/2012
04/03/2013 Centralised - Variation EMEA/H/C/2075/IB/3
Updated with Decision(2014)2062 of 21/03/2014
20/02/2014 Centralised - Notification EMEA/H/C/2075/N/5
Updated with Decision(2014)2062 of 21/03/2014
25/03/2014 Centralised - Yearly update (2014)2062 of 21/03/2014
29/10/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2075/T/9 (2014)8183 of 27/10/2014
23/11/2015 Centralised - Renewal EMEA/H/C/2075/R/10 (2015)8297 of 19/11/2015
30/03/2016 Centralised - Variation EMEA/H/C/2075/IA/11
Updated with Decision(2017)1960 of 20/03/2017
22/03/2017 Centralised - Yearly update (2017)1960 of 20/03/2017