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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Auth. number :||EU/1/11/695|
|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|
Leganto is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in adults.
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
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register.
|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 - Variation||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||Centralised - Modification||EMEA/H/C/2380/PSU/7||(2013)3105 of 22/05/2013|
|02/08/2013||Centralised - Variation||EMEA/H/C/2380/WS/385||(2013)5133 of 31/07/2013|