EMEA-001428-PIP01-13 - paediatric investigation plan

Esketamine

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
• Decision type:
  RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
• Decision date:
  30/07/2013
• Compliance check done:
  No

Decision

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

Adopted Reference Number: EMA/419089/2013