Spravato REMS

GPTKB entity

Statements (22)
Predicate Object
gptkbp:instanceOf gptkb:Risk_Evaluation_and_Mitigation_Strategy
gptkbp:administeredBy certified healthcare settings
gptkbp:appliesTo gptkb:esketamine
gptkbp:approvedBy gptkb:FDA
gptkbp:associatedWith gptkb:Spravato
https://www.w3.org/2000/01/rdf-schema#label Spravato REMS
gptkbp:includes patient monitoring
patient enrollment
pharmacy certification
certification of healthcare settings
gptkbp:monitors dissociation
adverse events
abuse and misuse
serious sedation
gptkbp:notDispensedTo patients for home use
gptkbp:oversees gptkb:Janssen_Pharmaceuticals
gptkbp:purpose ensure safe use of Spravato
gptkbp:requires gptkb:FDA
Spravato prescription
gptkbp:website https://www.spravatorems.com/
gptkbp:bfsParent gptkb:Spravato
gptkbp:bfsLayer 8