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ACTIVE SUBSTANCE / INN

GOLIMUMAB

Brand name(s): Gobivaz, SIMPONI, Simponi, Gotenfia, SIMPONI ARIA
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
Arthritis, Psoriatic;Spondylitis, Ankylosing;Colitis, Ulcera…
Arthritis, Rheumatoid;Arthritis, Juvenile;Arthritis, Psoriat…
ACTIVE SUBSTANCE
Golimumab
REGULATORS
FDA · EMA
SPONSORS / MAH
Janssen Cilag International NV, JANSSEN BIOTECH, Advanz Pharma Limited
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
SIMPONIBLA125289CENTOCOR ORTHO BIOTECH INCPrescription
SIMPONI ARIABLA125433JANSSEN BIOTECHPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
SimponiJanssen Cilag International NVAuthorised01/10/2009Arthritis, Psoriatic;Spondylitis, Ankylosing;Colitis, Ulcerative;Arthritis, Rheu…
GotenfiaStada Arzneimittel AGAuthorised10/02/2026Arthritis, Rheumatoid;Arthritis, Juvenile;Arthritis, Psoriatic;Axial Spondyloart…
GobivazAdvanz Pharma LimitedAuthorised17/11/2025Arthritis, Rheumatoid;Arthritis, Juvenile;Arthritis, Psoriatic;Axial Spondyloart…

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