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SPRAVATO® REMS Outpatient Healthcare Setting EnrollmentOutpatient Healthcare Settings must be certified in the SPRAVATO® REMS in order to prescribe product.
SPRAVATO® is intended for patient administration under the direct observation of a healthcare provider, due to risks of serious adverse outcomes resulting from sedation, dissociation, and respiratory depression caused by SPRAVATO administration, and abuse and misuse of SPRAVATO.
SPRAVATO® is intended for use only in a certified Healthcare Setting.
What is Spravato?
Spravato is a prescription medicine used:with or without an antidepressant taken by mouth, to treat adults with treatment-resistant depression (TRD)with an antidepressant taken by mouth, to treat depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions
SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic).It is not known if SPRAVATO® is safe or effective as an anesthetic medicine.It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions.
SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®.It is not known if SPRAVATO® is safe and effective in children.
