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ACTIVE SUBSTANCE / INN

FINGOLIMOD

Brand name(s): Gilenya, Fingolimod Mylan, FINGOLIMOD, Fingolimod Accord
FDA LISTED
EMA LISTED
APPLICATION WITHDRAWN
AUTHORISED
NONE (TENTATIVE APPROVAL)
Multiple Sclerosis, Relapsing-Remitting
ANDA208559
ACTIVE SUBSTANCE
Fingolimod
REGULATORS
FDA · EMA
SPONSORS / MAH
Mylan Ireland Limited, MSN LABS PVT LTD, Novartis Europharm Limited
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
FINGOLIMODANDA208559MSN LABS PVT LTDNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Fingolimod AccordAccord Healthcare S.L.U.Authorised25/06/2020Multiple Sclerosis, Relapsing-Remitting
GilenyaNovartis Europharm LimitedAuthorised17/03/2011Multiple Sclerosis
Fingolimod MylanMylan Pharmaceuticals LimitedAuthorised18/08/2021Multiple Sclerosis, Relapsing-Remitting
Fingolimod MylanMylan Ireland LimitedApplication withdrawn18/08/2021Multiple Sclerosis, Relapsing-Remitting

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