EMEA-003032-PIP01-21-M01 - paediatric investigation plan

Ibutamoren mesilate

Key facts

• Active Substance:
  Ibutamoren mesilate
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0073/2023
• PIP number:
  EMEA-003032-PIP01-21-M01
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of growth hormone deficiency
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Lumos Pharma, Inc.

  Email: [e-mail] ; Tel: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/03/2023

Decision

P/0073/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for ibutamoren mesylate (EMEA-003032-PIP01-21-M01)

Adopted