Product detail for Upadacitimab, INN: upadacitimab. Therapeutic area: Immunology. This record shows all linked substances, markets, applications, presentations, and labeling artefacts.

Product ID
PROD-023
INN
upadacitimab
Therapeutic Area
Immunology
Status
Pending
Owner
James O'Brien
Created
2022-08-25
Last Updated
2023-04-30
Markets
11
Presentations
FormStrengthRoute
Ophthalmic solution25 mgTopical
Transdermal patch1 mg/mLInhalation
Oral solution0.5 mgIntravitreal
Film-coated tablet5 mgOral
Active Substances
IDNameINNCASTypeStatus
SUB-020Erenumabixerenumabix80035-23-4biologicActive
SUB-024Semaglutidexsemaglutidex51393-36-2small-moleculeActive
Applications (3)
Application #MarketProcedure TypeStatusOwnerSubmitted
PMDA-2022-0023South AfricaLifecycle ExtensionIn ProgressLieselotte van der Berg2024-06-19
CDSCO-2022-0053South AfricaType II VariationOverdueSarah Chen2023-01-28
PMDA-2022-0083South AfricaType II VariationBlockedSarah Chen2023-04-22
Labeling Artefacts
IDTypeMarketVersionLanguageStatus
LBL-023SmPCSouth Africa16.4ptApproved
LBL-053LabelingSouth Africa20.2enActive
LBL-083SmPCSouth Africa16.5plApproved
LBL-113PILSouth Africa20.7deApproved
LBL-143LabelingSouth Africa4.0deActive