EMEA-002169-PIP01-17-M02 - paediatric investigation plan

Setrusumab

Key facts

• Active Substance:
  Setrusumab
• Therapeutic area:
  Other
• Decision number:
  P/0536/2022
• PIP number:
  EMEA-002169-PIP01-17-M02
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of osteogenesis imperfecta
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Mereo Biopharma 3 Ltd

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/12/2022

Decision

P/0536/2022 : EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for setrusumab (EMEA-002169-PIP01-17-M02)

AdoptedReference Number: EMA/901113/2022