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ACTIVE SUBSTANCE / INN

PRAMIPEXOLE

Brand name(s): Daquiran, Pramipexole Teva, Sifrol, Oprymea, Mirapexin, Pramipexole Accord
EMA LISTED
WITHDRAWN
AUTHORISED
Parkinson Disease
Restless Legs Syndrome;Parkinson Disease
ACTIVE SUBSTANCE
Pramipexole
REGULATORS
EMA
SPONSORS / MAH
Dr. Karl Thomae GmbH, Teva Pharma B.V., Boehringer Ingelheim International GmbH
TOTAL APPLICATIONS
6
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Pramipexole TevaTeva Pharma B.V.Authorised18/12/2008Parkinson Disease
OprymeaKrka, d.d., Novo mestoAuthorised12/09/2008Parkinson Disease
MirapexinBoehringer Ingelheim International GmbHAuthorised23/02/1998Restless Legs Syndrome;Parkinson Disease
SifrolBoehringer Ingelheim International GmbHAuthorised13/10/1997Restless Legs Syndrome;Parkinson Disease
Pramipexole AccordAccord Healthcare S.L.U.Withdrawn29/09/2011Parkinson Disease;Restless Legs Syndrome
DaquiranDr. Karl Thomae GmbHWithdrawn27/10/1997Parkinson Disease

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