EMEA-001181-PIP01-11-M06 - paediatric investigation plan

Agomelatine

Key facts

• Invented name:
  Valdoxan and associated names
• Active Substance:
  Agomelatine
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0115/2021
• PIP number:
  EMEA-001181-PIP01-11-M06
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of major depressive episodes
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/03/2021
• Compliance procedure number:
  EMEA-C-001181-PIP01-11-M06
• Compliance opinion date:
  14/10/2022
• Compliance outcome:
  Positive

Decision

P/0115/2021 : EMA decision of 17 March 2021 on the acceptance of a modification of an agreed paediatric investigation plan for agomelatine (Valdoxan and associated names) (EMEA-001181-PIP01-11-M06)

Reference Number: EMA/93279/2021