EMEA-003148-PIP01-21 - paediatric investigation plan

Oxytocin

Key facts

• Active substance:
  Oxytocin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0285/2022
• PIP number:
  EMEA-003148-PIP01-21
• Pharmaceutical form(s):
  Nasal spray (solution)
• Condition(s) / indication(s):
  Treatment of Prader-Willi syndrome
• Route(s) of administration:
  Nasal use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  11/08/2022
• Compliance check done:
  Ne

Decision

P/0285/2022: EMA decision of 11 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for oxytocin (EMEA-003148-PIP01-21)

Reference Number: EMA/629295/2022