Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Stalevo   
Auth. number : EU/1/03/260
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: Stalevo is indicated for the treatment of 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, 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
22/10/2003 Centralised - Authorisation EMEA/H/C/511 (2003)3931 of 17/10/2003
12/01/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/1
12/01/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/2
18/02/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/3
20/07/2004 Centralised - Notification EMEA/H/C/511/N/4
Updated with Decision(2005)1066 of 29/03/2005
11/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/5
31/03/2005 Centralised - Variation EMEA/H/C/511/II/6 (2005)1066 of 29/03/2005
01/09/2005 Centralised - Variation EMEA/H/C/511/II/7 (2005)3385 of 30/08/2005
21/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/9
21/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/8
21/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/10
21/03/2006 Centralised - Variation EMEA/H/C/511/IA/14
Updated with Decision(2006)3250 of 11/07/2006
21/03/2006 Centralised - Variation EMEA/H/C/511/IA/13
Updated with Decision(2006)3250 of 11/07/2006
21/03/2006 Centralised - Variation EMEA/H/C/511/IA/12
Updated with Decision(2006)3250 of 11/07/2006
07/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/15
24/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IB/19
24/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IB/18
24/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/15
24/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/16
13/07/2006 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/511/T/20 (2006)3250 of 11/07/2006
25/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/23
26/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/21
02/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IB/22
02/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IB/24
12/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IB/26
26/01/2007 Centralised - Variation EMEA/H/C/511/II/25 (2007)246 of 24/01/2007
26/02/2007 Centralised - Variation EMEA/H/C/511/IA/29
Updated with Decision(2007)4099 of 29/08/2007
26/02/2007 Centralised - Variation EMEA/H/C/511/IA/28
Updated with Decision(2007)4099 of 29/08/2007
26/02/2007 Centralised - Variation EMEA/H/C/511/IA/27
Updated with Decision(2007)4099 of 29/08/2007
23/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/30
11/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/32
31/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/34
31/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/36
03/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IB/35
31/08/2007 Centralised - Variation EMEA/H/C/511/II/31 (2007)4099 of 29/08/2007
11/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/38
19/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/II/37
23/04/2008 Centralised - Variation EMEA/H/C/511/X/33 (2008)1650 of 21/04/2008
30/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/43
30/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/44
01/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IB/42
01/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IB/41
17/09/2008 Centralised - Renewal EMEA/H/C/511/R/40 (2008)5219 of 15/09/2008
15/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/47
10/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/49
09/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/50
23/12/2008 Centralised - Notification EMEA/H/C/511/N/48
Updated with Decision(2009)2463 of 27/03/2009
09/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/52
23/03/2009 Centralised - Variation EMEA/H/C/511/II/51 (2009)2127 of 19/03/2009
01/04/2009 Centralised - Variation EMEA/H/C/511/X/45, 46 (2009)2463 of 27/03/2009
11/08/2009 Centralised - Notification EMEA/H/C/511/N/53
Updated with Decision(2010)2043 of 23/03/2010
11/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/55
25/03/2010 Centralised - Variation EMEA/H/C/511/II/54 (2010)2043 of 23/03/2010
15/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IA/57/G
04/06/2010 Centralised - Variation EMEA/H/C/511/II/56 (2010)3654 of 02/06/2010
30/08/2010 Centralised - Variation EMEA/H/C/511/II/58 (2010)6008 of 26/08/2010
25/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/511/IB/59
30/08/2011 Centralised - Variation EMEA/H/C/511/X/60 (2011)6179 of 24/08/2011
16/01/2013 Centralised - Variation EMEA/H/C/511/WS/331 (2013)127 of 14/01/2013
14/08/2013 Centralised - Notification EMEA/H/C/511/N/71
22/01/2015 Centralised - Variation EMEA/H/C/511/WS/665