Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Leganto   
Auth. number : EU/1/11/695
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: Restless Legs Syndrome
Restless Legs Syndrome.
Parkinson’s disease
Leganto is indicated for the 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
22/06/2011 Centralised - Authorisation EMEA/H/C/2380 (2011)4407 of 16/06/2011
26/08/2011 Centralised - Variation EMEA/H/C/2380/IA/2/G
Updated with Decision(2012)91 of 09/01/2012
14/12/2011 Centralised - Notification EMEA/H/C/2380/N/3
Updated with Decision(2012)6154 of 30/08/2012
11/01/2012 Centralised - Variation EMEA/H/C/2380/II/1 (2012)91 of 09/01/2012
04/09/2012 Centralised - Variation EMEA/H/C/2380/WS/226/G (2012)6154 of 30/08/2012
20/12/2012 Centralised - Variation EMEA/H/C/2380/WS/286/G, EMEA/H/C/2380/WS/293 (2012)9859 of 18/12/2012
27/05/2013 PSUSA - Modification EMEA/H/C/2380/PSU/7 (2013)3105 of 22/05/2013
02/08/2013 Centralised - 2-Monthly update EMEA/H/C/2380/WS/385 (2013)5133 of 31/07/2013
23/01/2014 Centralised - Variation EMEA/H/C/2380/WS/450
Updated with Decision(2014)9039 of 21/11/2014
25/11/2014 PSUSA - Modification EMEA/H/C/2380/PSUV/13 (2014)9039 of 21/11/2014
26/02/2015 Centralised - Variation EMEA/H/C/2380/WS/674
Updated with Decision(2016)243 of 14/01/2016
26/02/2015 Centralised - Variation EMEA/H/C/2380/WS/684
Updated with Decision(2016)243 of 14/01/2016
19/01/2016 Centralised - Renewal EMEA/H/C/2380/R/19 (2016)243 of 14/01/2016
25/02/2016 Centralised - Variation EMEA/H/C/2380/WS/886/G