Key facts

Active Substance
Esketamine
Therapeutic area
Psychiatry
Decision number
P/0177/2013
PIP number
EMEA-001428-PIP01-13
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 N.V. 

E-mail: mojanen@ITS.JNJ.com
Tel. +34 917228079

Decision type
RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Decision date

Decision

P/0177/2013: EMA decision of 30 July 2013 on the refusal of a product-specific waiver for esketamine (EMEA-001428-PIP01-13)

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