EMEA-002323-PIP02-19 - paediatric investigation plan

relamorelin

Key facts

• Active substance:
  relamorelin
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0367/2020
• PIP number:
  EMEA-002323-PIP02-19
• Pharmaceutical form(s):
  • Age appropriate oral dosage formulation
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of gastroparesis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  09/09/2020
• Compliance check done:
  No

Decision

P/0367/2020 : EMA decision of 9 September 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal of a waiver for relamorelin (EMEA-002323-PIP02-19)

Adopted Reference Number: EMA/419263/2020