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ACTIVE SUBSTANCE / INN

DIMETHYL FUMARATE

Brand name(s): Dimethyl fumarate Teva, DIMETHYL FUMARATE, Tecfidera, Dimethyl fumarate Polpharma, Dimethyl fumarate Neuraxpharm, Dimherity, Dimethyl fumarate Mylan, Dimethyl fumarate Accord, TECFIDERA, Skilarence
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
REVOKED
ANDA210226
Psoriasis
ACTIVE SUBSTANCE
Dimethyl Fumarate
REGULATORS
FDA · EMA
SPONSORS / MAH
Mylan Ireland Limited, Neuraxpharm Pharmaceuticals S.L., Teva GmbH
TOTAL APPLICATIONS
15
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
DIMETHYL FUMARATEANDA210226LUPINPrescription
DIMETHYL FUMARATEANDA210390TORRENTDiscontinued
TECFIDERANDA204063BIOGEN INCPrescription
DIMETHYL FUMARATEANDA210291SHILPA MEDICARE LTDNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Dimethyl fumarate AccordAccord Healthcare LtdAuthorised22/04/2024Multiple Sclerosis
Dimethyl fumarate MylanMylan Ireland LimitedAuthorised22/04/2024Multiple Sclerosis
SkilarenceAlmirall, S.A.Authorised23/06/2017Psoriasis
Dimethyl fumarate NeuraxpharmNeuraxpharm Pharmaceuticals S.L.Authorised22/04/2024Multiple Sclerosis
TecfideraBiogen Netherlands B.V.Authorised30/01/2014Multiple Sclerosis
Dimethyl fumarate TevaTeva GmbHRevoked12/12/2022Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis
Dimethyl fumarate NeuraxpharmLaboratorios Lesvi S.L.Revoked13/05/2022Multiple Sclerosis, Relapsing-Remitting
Dimethyl fumarate AccordAccord Healthcare S.L.U.Revoked15/02/2023Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis
Dimethyl fumarate PolpharmaZaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.Revoked13/05/2022Multiple Sclerosis, Relapsing-Remitting
Dimethyl fumarate MylanMylan Ireland LimitedRevoked13/05/2022Multiple Sclerosis, Relapsing-Remitting

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