Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Comtan   
Auth. number : EU/1/98/081
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: Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom

  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
23/09/1998 Centralised - Authorisation EMEA/H/C/171 (1998)2649 of 22/09/1998
19/03/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/171/I/2
12/05/1999 Centralised - Variation EMEA/H/C/171/II/1 (1999)1272 of 07/05/1999
26/05/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/171/I/3
27/04/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/171/I/5
03/08/2000 Centralised - Variation EMEA/H/C/171/II/4 (2000)2325 of 27/07/2000
02/05/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/171/II/6
20/08/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/171/I/8
24/08/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/171/I/9
18/10/2001 Centralised - Variation EMEA/H/C/171/II/7 (2001)2852 of 18/10/2001
07/01/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/171/I/12
07/01/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/171/I/13
14/02/2002 Centralised - Notification EMEA/H/C/171/N/10 (2002)512 of 07/02/2002
08/03/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/171/I/11
02/10/2002 Centralised - Variation EMEA/H/C/171/II/14 (2002)3659 of 30/09/2002
03/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/171/I/15, 17
06/05/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/171/I/18, 19
16/05/2003 Centralised - Variation EMEA/H/C/171/I/16 (2003)1648 of 14/05/2003
22/10/2003 Centralised - Renewal EMEA/H/C/171/R/20 (2003)3930 of 17/10/2003
25/02/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/171/IA/21
20/07/2004 Centralised - Notification EMEA/H/C/171/N/22
Updated with Decision(2005)668 of 07/03/2005
09/03/2005 Centralised - Variation EMEA/H/C/171/II/23 (2005)668 of 07/03/2005
12/05/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/171/IA/25
03/08/2005 Centralised - Variation EMEA/H/C/171/II/24 (2005)3048 of 01/08/2005
01/03/2007 Centralised - Variation EMEA/H/C/171/II/26 (2007)705 of 27/02/2007
01/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/171/IA/27
01/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/171/IA/28
21/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/171/IA/29
17/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/171/IA/34
17/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/171/IA/33
18/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/171/IB/31
18/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/171/IB/32
08/09/2008 Centralised - Renewal EMEA/H/C/171/R/30 (2008)4984 of 03/09/2008
14/06/2010 Centralised - Variation EMEA/H/C/171/II/35/G (2010)3898 of 10/06/2010
12/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/171/IA/36/G
10/10/2012 Centralised - Variation (2012)7158 of 08/10/2012
17/12/2012 Centralised - Variation EMEA/H/C/171/IB/41
Updated with Decision(2013)9838 of 20/12/2013
25/10/2013 Centralised - Notification EMEA/H/C/171/N/43
Updated with Decision(2013)9838 of 20/12/2013
02/01/2014 Centralised - Yearly update (2013)9838 of 20/12/2013
13/11/2014 Centralised - Variation EMEA/H/C/171/IAIN/45