EMEA-000145-PIP01-07-M09 - paediatric investigation plan

denosumab

Key facts

• Invented name:
  • Xgeva; Prolia
  • • Prolia
    • Xgeva
• Active substance:
  denosumab
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0098/2018
• PIP number:
  EMEA-000145-PIP01-07-M09
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Prevention of skeletal related events in patients with bone metastases
  • Treatment of bone loss associated with sex hormone ablative therapy
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis)
  • Treatment of giant cell tumour of bone
  • Treatment of hypercalcemia of malignancy
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/03/2018
• Compliance check done:
  Oui
• Compliance procedure number:
  EMEA-C-000145-PIP01-07-M09
• Compliance opinion date:
  01/03/2019
• Compliance outcome:
  Positive

Decision

P/0098/2018: EMA decision of 16 March 2018 on the acceptance of a modification of an agreed paediatric investigation plan for denosumab (Xgeva, Prolia), (EMEA-000145-PIP01-07-M09)

Adopted Reference Number: EMA/107500/2018