EMEA-001428-PIP03-15-M02

Key facts

Invented name
Spravato
Active substance
Esketamine (hydrochloride)
Therapeutic area
Psychiatry
Decision number
P/0136/2022
PIP number
EMEA-001428-PIP03-15-M02
Pharmaceutical form(s)
Nasal spray, solution
Condition(s) / indication(s)
Treatment of major depressive disorder
Route(s) of administration
Intranasal use
Contact for public enquiries
Janssen-Cilag International NV

Tel. +32 1460 2111

E-mail: contact@janssen-emea.com

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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