Product detail for Raredimab, INN: raredimab. Therapeutic area: Rare Disease. This record shows all linked substances, markets, applications, presentations, and labeling artefacts.

Product ID
PROD-009
INN
raredimab
Therapeutic Area
Rare Disease
Status
Active
Owner
Sarah Chen
Created
2022-04-27
Last Updated
2023-09-13
Markets
11
Presentations
FormStrengthRoute
Powder for injection100 mg/mLIntravitreal
Transdermal patch25 mgTopical
Powder for injection400 mgIntramuscular
Soft capsule200 mgSubcutaneous
Active Substances
IDNameINNCASTypeStatus
SUB-017Thymosilibthymosilib94484-27-2biologicActive
SUB-032Excipient Bexcipient b21673-75-1small-moleculeActive
Applications (4)
Application #MarketProcedure TypeStatusOwnerSubmitted
SwissMedic-2021-0009SwitzerlandMAAIn ProgressMarcus Webb2022-06-06
Roszdravnadzor-2021-0039SwitzerlandType IB VariationDraftSarah Chen2023-06-16
SwissMedic-2021-0069SwitzerlandBLAActiveJames O'Brien2022-10-07
Roszdravnadzor-2021-0099SwitzerlandMAAOverdueAisha Okonkwo2023-08-13
Labeling Artefacts
IDTypeMarketVersionLanguageStatus
LBL-009SmPCSwitzerland5.9deIn Progress
LBL-039PILSwitzerland13.4nlPending
LBL-069SmPCSwitzerland17.3itApproved
LBL-099LabelingSwitzerland20.4esPending
LBL-129PILSwitzerland19.9nlApproved