EMEA-000145-PIP02-12-M04 - paediatric investigation plan

denosumab

Key facts

• Invented name:
  • Xgeva
  • Prolia
• Active Substance:
  denosumab
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0213/2021
• PIP number:
  EMEA-000145-PIP02-12-M04
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of osteoporosis
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Amgen Europe B.V.

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  21/05/2021

Decision

P/0213/2021 : EMA decision of 21 May 2021 on the acceptance of a modification of an agreed paediatric investigation plan for denosumab (Prolia, Xgeva), (EMEA-000145-PIP02-12-M04)

AdoptedReference Number: EMA/277014/2021