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ACTIVE SUBSTANCE / INN

INFLIXIMAB

Brand name(s): Flixabi, REMICADE, Remsima, ABP 710, Zessly, Inflectra, Remicade
FDA LISTED
EMA LISTED
PRESCRIPTION
APPLICATION WITHDRAWN
AUTHORISED
Arthritis, Psoriatic;Spondylitis, Ankylosing;Colitis, Ulcera…
Arthritis, Psoriatic;Psoriasis;Crohn Disease;Arthritis, Rheu…
ACTIVE SUBSTANCE
Infliximab
REGULATORS
FDA · EMA
SPONSORS / MAH
Janssen Cilag International NV, Celltrion Healthcare Hungary Kft., CENTOCOR INC
TOTAL APPLICATIONS
7
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
REMICADEBLA103772CENTOCOR INCPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
RemsimaCelltrion Healthcare Hungary Kft.Authorised10/09/2013Arthritis, Psoriatic;Spondylitis, Ankylosing;Colitis, Ulcerative;Psoriasis;Crohn…
InflectraPfizer Europe MA EEIGAuthorised10/09/2013Arthritis, Psoriatic;Spondylitis, Ankylosing;Colitis, Ulcerative;Psoriasis;Crohn…
RemicadeJanssen Cilag International NVAuthorised13/08/1999Spondylitis, Ankylosing;Arthritis, Rheumatoid;Psoriasis;Crohn Disease;Arthritis,…
FlixabiSamsung Bioepis NL B.V.Authorised26/05/2016Arthritis, Psoriatic;Spondylitis, Ankylosing;Colitis, Ulcerative;Arthritis, Rheu…
ZesslySandoz GmbHAuthorised18/05/2018Arthritis, Psoriatic;Psoriasis;Crohn Disease;Arthritis, Rheumatoid;Colitis, Ulce…
ABP 710Amgen Europe B.V.Application withdrawn—

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