Product detail for Respiralimab, INN: respiralimab. Therapeutic area: Respiratory. This record shows all linked substances, markets, applications, presentations, and labeling artefacts.

Product ID
PROD-012
INN
respiralimab
Therapeutic Area
Respiratory
Status
Pending
Owner
Priya Sharma
Created
2022-07-27
Last Updated
2024-04-10
Markets
8
Presentations
FormStrengthRoute
Ophthalmic solution10 mg/mLInhalation
Inhalation powder100 mgIntramuscular
Active Substances
IDNameINNCASTypeStatus
SUB-034Mannitolmannitol33013-15-7combinationPending
Applications (3)
Application #MarketProcedure TypeStatusOwnerSubmitted
HSA-2023-0012ItalysNDAIn ProgressPriya Sharma2023-01-28
EMA-2023-0042ItalyNDSBlockedPriya Sharma2024-02-09
HSA-2023-0072ItalyMAAFailedCarlos Mendez2024-06-04
Labeling Artefacts
IDTypeMarketVersionLanguageStatus
LBL-012SmPCItaly14.6koActive
LBL-042PILItaly3.0svApproved
LBL-072PILItaly14.8nlActive
LBL-102SmPCItaly8.1itApproved
LBL-132SmPCItaly12.4nlIn Progress