ACTIVE SUBSTANCE / INN

ADALIMUMAB

Brand name(s): Hulio, Imraldi, Hukyndra, Hyrimoz, Idacio, Amgevita, Yuflyma, Libmyris, Kromeya, Solymbic, Humira, Fyzoclad, Trudexa, Cyltezo, HUMIRA, Hefiya, Amsparity, Halimatoz
FDA LISTED
EMA LISTED
PRESCRIPTION
APPLICATION WITHDRAWN
WITHDRAWN
Spondylitis, Ankylosing;Arthritis, Rheumatoid;Arthritis, Pso…
BLA125057
ACTIVE SUBSTANCE
Adalimumab
REGULATORS
FDA · EMA
SPONSORS / MAH
Celltrion Healthcare Hungary Kft., Sandoz GmbH, Stada Arzneimittel AG
TOTAL APPLICATIONS
18
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
HUMIRABLA125057ABBVIE INCPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
HulioBiosimilar Collaborations Ireland LimitedAuthorised17/09/2018Hidradenitis Suppurativa;Psoriasis;Uveitis;Arthritis, Rheumatoid;Spondylitis, An…
HefiyaSandoz GmbHAuthorised26/07/2018Spondylitis, Ankylosing;Hidradenitis Suppurativa;Psoriasis;Arthritis, Juvenile R…
YuflymaCelltrion Healthcare Hungary Kft.Authorised11/02/2021Arthritis, Rheumatoid;Arthritis, Psoriatic;Psoriasis;Spondylitis, Ankylosing;Uve…
ImraldiSamsung Bioepis NL B.V.Authorised24/08/2017Spondylitis, Ankylosing;Arthritis, Rheumatoid;Uveitis;Colitis, Ulcerative;Psoria…
HukyndraStada Arzneimittel AGAuthorised15/11/2021Arthritis, Psoriatic;Arthritis, Juvenile Rheumatoid;Arthritis, Rheumatoid;Coliti…
LibmyrisStada Arzneimittel AGAuthorised12/11/2021Arthritis, Rheumatoid;Arthritis, Juvenile Rheumatoid;Spondylitis, Ankylosing;Art…
HyrimozSandoz GmbHAuthorised26/07/2018Arthritis, Rheumatoid;Arthritis, Psoriatic;Spondylitis, Ankylosing;Uveitis;Hidra…
AmsparityPfizer Europe MA EEIGAuthorised13/02/2020Arthritis, Rheumatoid;Arthritis, Psoriatic;Psoriasis;Spondylitis, Ankylosing;Uve…
IdacioFresenius Kabi Deutschland GmbHAuthorised02/04/2019Arthritis, Rheumatoid;Arthritis, Psoriatic;Psoriasis;Spondylitis, Ankylosing;Uve…
HumiraAbbVie Deutschland GmbH & Co. KGAuthorised08/09/2003Spondylitis, Ankylosing;Arthritis, Juvenile Rheumatoid;Uveitis;Colitis, Ulcerati…

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