EMEA-001988-PIP01-16-M01 - paediatric investigation plan

Macimorelin

Key facts

• Invented name:
  Ghryvelin (previously Macimorelin Aeterna Zentaris)
• Active Substance:
  Macimorelin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0076/2020
• PIP number:
  EMEA-001988-PIP01-16-M01
• Pharmaceutical form(s):
  Granules for oral solution
• Condition(s) / indication(s):
  Diagnosis of growth hormone deficiency
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Aeterna Zentaris GmbH

  E-mail: [e-mail]; Tel.: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  06/04/2020

Decision

P/0076/2020: EMA decision of 6 April 2020 on the acceptance of a modification of an agreed paediatric investigation plan for Macimorelin (Macimorelin Aeterna Zentaris) (EMEA-001988-PIP01-16-M01)

AdoptedReference Number: EMA/167090/2020