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ACTIVE SUBSTANCE / INN

USTEKINUMAB

Brand name(s): Otulfi, Uzpruvo, Imuldosa, Upstelda, Usymro, Usrenty, Yesintek, Qoyvolma, Steqeyma, Usgena, Absimky, Stelara, STELARA, Eksunbi, Fymskina, Pyzchiva, Wezenla
FDA LISTED
EMA LISTED
PRESCRIPTION
APPLICATION WITHDRAWN
WITHDRAWN
Crohn Disease;Psoriasis;Arthritis, Psoriatic;Colitis, Ulcera…
Crohn Disease;Psoriasis;Arthritis, Psoriatic
ACTIVE SUBSTANCE
Ustekinumab
REGULATORS
FDA · EMA
SPONSORS / MAH
Janssen-Cilag International NV, Celltrion Healthcare Hungary Kft., Formycon AG
TOTAL APPLICATIONS
17
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
STELARABLA125261CENTOCOR ORTHO BIOTECH INCPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
SteqeymaCelltrion Healthcare Hungary Kft.Authorised22/08/2024Psoriasis;Arthritis, Psoriatic;Crohn Disease
FymskinaFormycon AGAuthorised25/09/2024Crohn Disease;Psoriasis;Arthritis, Psoriatic
WezenlaAmgen Technology (Ireland) UCAuthorised20/06/2024Psoriasis;Arthritis, Psoriatic;Crohn Disease
UsrentyBiosimilar Collaborations Ireland LimitedAuthorised17/09/2025Crohn Disease
YesintekBiosimilar Collaborations Ireland LimitedAuthorised14/02/2025Psoriasis;Arthritis, Psoriatic;Crohn Disease
UzpruvoStada Arzneimittel AGAuthorised05/01/2024Psoriasis;Arthritis, Psoriatic;Crohn Disease;Colitis, Ulcerative
ImuldosaAccord Healthcare S.L.U.Authorised12/12/2024Crohn Disease;Psoriasis;Arthritis, Psoriatic
UsymroGedeon Richter Plc.Authorised14/08/2025Crohn Disease;Psoriasis;Arthritis, Psoriatic
AbsimkyAccord Healthcare S.L.U.Withdrawn12/12/2024Crohn Disease;Colitis, Ulcerative
PyzchivaSamsung Bioepis NL B.V.Authorised19/04/2024Crohn Disease;Colitis, Ulcerative;Arthritis, Psoriatic

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