EMEA-001988-PIP01-16-M02 - paediatric investigation plan

Macimorelin

Key facts

• Invented name:
  Ghryvelin (previously Macimorelin Aeterna Zentaris)
• Active substance:
  Macimorelin
• Therapeutic area:
  Endocrine disorders
• Decision number:
  P/0331/2024
• PIP number:
  EMEA-001988-PIP01-16-M02
• Pharmaceutical form(s):
  Granules for oral solution
• Condition(s) / indication(s):
  Diagnosis of growth hormone deficiency
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/09/2024
• Compliance check done:
  No

Decision

P/0331/2024: EMA decision of 13 September 2024 on the acceptance of a modification of an agreed paediatric investigation plan for macimorelin (Ghryvelin), (EMEA-001988-PIP01-16-M02)

Adopted Reference Number: EMA/413906/2024