Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Comtess   
Auth. number : EU/1/98/082
INN : 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, 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
18/09/1998 Centralised - Authorisation EMEA/H/C/170 (1998)2644 of 16/09/1998
26/05/1999 Centralised - Notification EMEA/H/C/170/N/7 (1999)1319 of 18/05/1999
26/05/1999 Centralised - Variation EMEA/H/C/170/II/3 (1999)1319 of 18/05/1999
07/08/2000 Centralised - Variation EMEA/H/C/170/II/7 (2000)2315 of 27/07/2000
02/05/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/170/II/10
20/08/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/170/I/12
24/08/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/170/I/13
25/10/2001 Centralised - Variation EMEA/H/C/170/I/11 (2001)2973 of 24/10/2001
07/01/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/170/I/15
07/01/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/170/I/19
07/01/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/170/I/18
14/02/2002 Centralised - Notification EMEA/H/C/170/N/14 (2002)513 of 07/02/2002
08/03/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/170/I/17
02/10/2002 Centralised - Variation EMEA/H/C/170/II/20 (2002)3663 of 30/09/2002
06/05/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/170/I/21, 22
22/10/2003 Centralised - Renewal EMEA/H/C/170/R/23 (2003)3933 of 17/10/2003
25/02/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/170/IA/24
09/03/2005 Centralised - Variation EMEA/H/C/170/II/25 (2005)667 of 07/03/2005
13/05/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/170/IA/26
02/05/2006 Centralised - Variation EMEA/H/C/170/II/27 (2006)1800 of 27/04/2006
22/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/170/IA/29
25/05/2006 Centralised - Variation EMEA/H/C/170/IA/28
Updated with Decision(2006)3250 of 11/07/2006
31/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/170/IB/30
16/06/2006 Centralised - Variation EMEA/H/C/170/IA/32
Updated with Decision(2007)256 of 24/01/2007
13/07/2006 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/170/T/31 (2006)3250 of 11/07/2006
26/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/170/IA/33
26/01/2007 Centralised - Variation (2007)256 of 24/01/2007
06/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/170/II/35
01/03/2007 Centralised - Variation EMEA/H/C/170/II/34 (2007)704 of 27/02/2007
13/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/170/I/36
30/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/170/IA/40
30/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/170/IA/41
01/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/170/IB/38
01/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/170/IB/39
08/09/2008 Centralised - Renewal EMEA/H/C/170/R/37 (2008)4985 of 03/09/2008
07/08/2009 Centralised - Notification EMEA/H/C/170/N/42
Updated with Decision(2010)3899 of 10/06/2010
14/06/2010 Centralised - Variation EMEA/H/C/170/II/43/G (2010)3899 of 10/06/2010
29/01/2013 Centralised - Variation EMEA/H/C/170/WS/331 (2013)492 of 24/01/2013
14/08/2013 Centralised - Notification EMEA/H/C/170/N/46
03/07/2014 Centralised - Notification EMEA/H/C/170/N/48