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ACTIVE SUBSTANCE / INN

ROTIGOTINE

Brand name(s): NEUPRO, Leganto, Rotigotine Mylan, Neupro
FDA LISTED
EMA LISTED
PRESCRIPTION
APPLICATION WITHDRAWN
WITHDRAWN
Restless Legs Syndrome;Parkinson Disease
NDA021829
ACTIVE SUBSTANCE
Rotigotine
REGULATORS
FDA · EMA
SPONSORS / MAH
UCB Pharma S.A.  , Mylan S.A.S, UCB INC
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
NEUPRONDA021829UCB INCPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
NeuproUCB Pharma S.A.Authorised15/02/2006Restless Legs Syndrome;Parkinson Disease
LegantoUCB Pharma S.A.  Withdrawn16/06/2011Restless Legs Syndrome;Parkinson Disease
Rotigotine MylanMylan S.A.SApplication withdrawnRestless Legs Syndrome;Parkinson Disease

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