Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Neupro   
Auth. number : EU/1/05/331
Active substance : Rotigotine
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N04 - Anti-parkinson drugs
Pharmacological subgroup: N04B - Dopaminergic agents
Chemical subgroup: N04BC - Dopamine agonists
Chemical substance: N04BC09 - Rotigotine
(See WHO ATC Index)
Indication: Neupro 1 mg/24 h, 2 mg/24 h and 3 mg/24 h transdermal patches: symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in adults.
Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h transdermal patches: treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or ‘on-off’ fluctuations).
Marketing Authorisation Holder: UCB Manufacturing Ireland Ltd
Shannon Industrial Estate, Co, Clare, Ireland
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
17/02/2006 Centralised - Authorisation EMEA/H/C/626 (2006)536 of 15/02/2006
18/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/626/IA/1
03/08/2006 Centralised - Variation EMEA/H/C/626/IA/4
Updated with Decision(2007)88 of 09/01/2007
29/08/2006 Centralised - Notification EMEA/H/C/626/N/2
Updated with Decision(2007)88 of 09/01/2007
17/11/2006 Centralised - Notification EMEA/H/C/626/N/5
Updated with Decision(2007)88 of 09/01/2007
11/01/2007 Centralised - Variation EMEA/H/C/626/II/3 (2007)88 of 09/01/2007
23/02/2007 Centralised - Notification EMEA/H/C/626/N/6
Updated with Decision(2008)4329 of 04/08/2008
23/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/626/IA/7
16/04/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/626/IB/8
05/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/626/IA/12
05/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/626/IA/11
05/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/626/IA/17
05/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/626/IA/15
05/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/626/IA/14
05/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/626/IA/10
05/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/626/IA/16
05/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/626/IA/9
05/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/626/IA/13
03/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/626/IB/18
18/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/626/IB/21
30/01/2008 Centralised - Notification EMEA/H/C/626/N/22
Updated with Decision(2008)4329 of 04/08/2008
06/08/2008 Referral EMEA/H/C/626/A-20/23 (2008)4329 of 04/08/2008
02/09/2008 Centralised - Variation EMEA/H/C/626/X/20 (2008)4780 of 29/08/2008
02/09/2008 Centralised - Variation EMEA/H/C/626/II/19 (2008)4781 of 29/08/2008
22/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/626/IB/26
01/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/626/II/25
13/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/626/IA/27
11/11/2008 Centralised - Variation EMEA/H/C/626/II/24 (2008)6796 of 06/11/2008
06/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/626/II/29
06/04/2009 Centralised - Variation EMEA/H/C/626/II/28 (2009)2699 of 02/04/2009
12/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/626/IB/32
02/06/2009 Centralised - Variation EMEA/H/C/626/IB/33
Updated with Decision(2009)5204 of 24/06/2009
26/06/2009 Centralised - Variation EMEA/H/C/626/II/30 (2009)5204 of 24/06/2009
21/07/2009 Centralised - Variation EMEA/H/C/626/II/31 (2009)5832 of 16/07/2009
02/09/2009 Centralised - Variation EMEA/H/C/626/II/34, 35 (2009)6746 of 31/08/2009
22/10/2009 Centralised - Notification EMEA/H/C/626/N/36
Updated with Decision(2010)1760 of 15/03/2010
18/03/2010 Centralised - Variation EMEA/H/C/626/II/37 (2010)1760 of 15/03/2010
21/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/626/IA/38
21/05/2010 Centralised - Variation EMEA/H/C/626/IA/41/G
Updated with Decision(2010)5842 of 18/08/2010
27/05/2010 Centralised - Variation EMEA/H/C/626/IB/42
Updated with Decision(2010)5842 of 18/08/2010
08/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/626/IB/39
24/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/626/IA/43/G
20/08/2010 Centralised - Variation (2010)5842 of 18/08/2010
02/12/2010 Centralised - Renewal EMEA/H/C/626/R/40 (2010)8665 of 29/11/2010
16/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/626/IB/45/G
25/02/2011 Centralised - Variation EMEA/H/C/626/II/44 (2011)1234 of 21/02/2011
26/08/2011 Centralised - Variation EMEA/H/C/626/II/50, 51, 52 (2011)6128 of 24/08/2011
08/09/2011 Centralised - Variation EMEA/H/C/626/IA/53/G
Updated with Decision(2012)2177 of 26/03/2012
05/01/2012 Centralised - Notification EMEA/H/C/626/N/54
Updated with Decision(2012)2177 of 26/03/2012
28/03/2012 Centralised - Variation (2012)2177 of 26/03/2012
04/05/2012 Corrigendum (2012)3075 of 02/05/2012
27/08/2012 Centralised - Variation EMEA/H/C/626/WS/226/G (2012)6027 of 23/08/2012
17/01/2013 Centralised - Variation EMEA/H/C/626/WS/293, EMEA/H/C/626/WS/286/G (2013)210 of 14/01/2013
29/05/2013 PSUSA - Modification EMEA/H/C/626/PSU/39 (2013)3233 of 27/05/2013
02/08/2013 Centralised - 2-Monthly update EMEA/H/C/626/WS/385 (2013)5134 of 31/07/2013
23/01/2014 Centralised - Variation EMEA/H/C/626/WS/450
Updated with Decision(2014)8899 of 19/11/2014
21/11/2014 PSUSA - Modification EMEA/H/C/626/PSUV/63 (2014)8899 of 19/11/2014
26/02/2015 Centralised - Variation EMEA/H/C/626/WS/684
26/02/2015 Centralised - Variation EMEA/H/C/626/WS/674