Product detail for Tisagenlecleux-B, INN: tisagenlecleux beta. Therapeutic area: Haematology. This record shows all linked substances, markets, applications, presentations, and labeling artefacts.

Product ID
PROD-025
INN
tisagenlecleux beta
Therapeutic Area
Haematology
Status
Pending
Owner
Priya Sharma
Created
2022-03-02
Last Updated
2023-07-15
Markets
6
Presentations
FormStrengthRoute
Ophthalmic solution1 mg/mLTransdermal
Film-coated tablet10 mg/mLInhalation
Ophthalmic solution50 mgTransdermal
Concentrate for solution for infusion2.5 mgSubcutaneous
Active Substances
IDNameINNCASTypeStatus
SUB-022Sacubitrivexsacubitrivex54693-87-2small-moleculeActive
SUB-030Mavacamtamexmavacamtamex81169-60-9small-moleculePending
Applications (3)
Application #MarketProcedure TypeStatusOwnerSubmitted
ANVISA-2020-0025PolandMAACompletedJames O'Brien2024-04-05
ANMAT-2020-0055PolandLabel UpdateDraftTomoko Ikeda2023-04-09
ANVISA-2020-0085PolandsNDAFailedTomoko Ikeda2022-05-13
Labeling Artefacts
IDTypeMarketVersionLanguageStatus
LBL-025IFUPoland19.8plIn Progress
LBL-055SmPCPoland2.9esPending
LBL-085PILPoland11.5svIn Progress
LBL-115LabelingPoland9.3enSubmitted
LBL-145PILPoland17.5ptApproved