ACTIVE SUBSTANCE / INN

ETANERCEPT

Brand name(s): Erelzi, ENBREL, Benepali, Lifmior, Nepexto, Enbrel, Fubelv
FDA LISTED
EMA LISTED
PRESCRIPTION
LAPSED
AUTHORISED
Arthritis, Rheumatoid;Arthritis, Juvenile Rheumatoid;Arthrit…
Arthritis, Rheumatoid;Arthritis, Juvenile;Arthritis, Psoriat…
ACTIVE SUBSTANCE
Etanercept
REGULATORS
FDA · EMA
SPONSORS / MAH
Sandoz GmbH, Pfizer Europe MA EEIG, Samsung Bioepis NL B.V.
TOTAL APPLICATIONS
7
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ENBRELBLA103795IMMUNEXPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
FubelvBiosimilar Collaborations Ireland LimitedOpinionArthritis, Rheumatoid;Arthritis, Juvenile;Arthritis, Psoriatic;Axial Spondyloart…
ErelziSandoz GmbHAuthorised23/06/2017Arthritis, Psoriatic;Psoriasis;Arthritis, Juvenile Rheumatoid;Arthritis, Rheumat…
BenepaliSamsung Bioepis NL B.V.Authorised13/01/2016Arthritis, Psoriatic;Arthritis, Rheumatoid;Psoriasis
EnbrelPfizer Europe MA EEIGAuthorised02/02/2000Spondylitis, Ankylosing;Arthritis, Juvenile Rheumatoid;Arthritis, Psoriatic;Psor…
NepextoBiosimilar Collaborations Ireland LimitedAuthorised20/05/2020Arthritis, Rheumatoid;Arthritis, Juvenile Rheumatoid;Arthritis, Psoriatic;Spondy…
LifmiorPfizer Europe MA EEIGLapsed13/02/2017Arthritis, Psoriatic;Spondylitis, Ankylosing;Psoriasis

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