EMEA-001075-PIP04-15-M06 - paediatric investigation plan

Romosozumab

Key facts

• Invented name:
  Evenity
• Active Substance:
  Romosozumab
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0171/2023
• PIP number:
  EMEA-001075-PIP04-15-M06
• 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:
  15/05/2023

Decision

P/0171/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for romosozumab (Evenity), (EMEA-001075-PIP04-15-M06)

AdoptedReference Number: EMA/171049/2023