EMEA-001075-PIP04-15-M07 - paediatric investigation plan

romosozumab

Key facts

• Invented name:
  Evenity
• Active substance:
  romosozumab
• Therapeutic area:
  Musculoskeletal and connective tissue disorders
• Decision number:
  P/0375/2024
• PIP number:
  EMEA-001075-PIP04-15-M07
• 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:
  24/10/2024
• Compliance check done:
  No

Decision

P/0375/2024: EMA decision of 24 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for romosozumab (EMEA-001075-PIP04-15-M07)

Adopted Reference Number: EMA/484740/2024