SPRAVATO (Janssen-Cilag Pty Ltd)
Product name
SPRAVATO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
305 (255 working days)
Active ingredients
esketamine hydrochloride
Registration type
NCE/NBE
Indication
SPRAVATO (nasal spray) is indicated for treatment resistant depression (Major Depressive Disorder in adults who have not responded adequately to at least two different antidepressants of adequate dose and duration to treat the current moderate to severe depressive episode).
SPRAVATO is to be initiated in conjunction with a newly initiated oral antidepressant.