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ACTIVE SUBSTANCE / INN

IDEBENONE

Brand name(s): Raxone, Puldysa, Sovrima
EMA LISTED
APPLICATION WITHDRAWN
REFUSED
AUTHORISED
Muscular Dystrophy, Duchenne
Friedreich Ataxia
ACTIVE SUBSTANCE
Idebenone
REGULATORS
EMA
SPONSORS / MAH
Santhera Pharmaceuticals (Deutschland) GmbH, Chiesi Farmaceutici S.p.A, Centocor B.V.
TOTAL APPLICATIONS
4
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
RaxoneChiesi Farmaceutici S.p.AAuthorised08/09/2015Optic Atrophy, Hereditary, Leber
PuldysaSanthera Pharmaceuticals (Deutschland) GmbHApplication withdrawnMuscular Dystrophy, Duchenne
RaxoneSanthera Pharmaceuticals (Deutschland) GmbHApplication withdrawnEye Diseases
SovrimaCentocor B.V.RefusedFriedreich Ataxia

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