EMEA-000145-PIP02-12-M05 - paediatric investigation plan

denosumab

Key facts

• Invented name:
  • Xgeva
  • Prolia
• Active substance:
  denosumab
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0123/2023
• PIP number:
  EMEA-000145-PIP02-12-M05
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of osteoporosis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/04/2023
• Compliance check done:
  Yes
• Compliance procedure number:
  EMA/PE/0000182467
• Compliance opinion date:
  13/12/2024
• Compliance outcome:
  Positive

Decision

P/0123/2023 : EMA decision of 14 April 2023 on the acceptance of a modification of an agreed paediatric investigation plan for denosumab (Prolia, Xgeva), (EMEA-000145-PIP02-12-M05)

Adopted Reference Number: EMA/134107/2023