EMEA-001554-PIP01-13-M03 - paediatric investigation plan

Etelcalcetide

Key facts

• Invented name:
  • Parsabiv
  • Parsabiv
• Active substance:
  Etelcalcetide
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0133/2022
• PIP number:
  EMEA-001554-PIP01-13-M03
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of hyperparathyroidism
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/04/2022
• Compliance check done:
  No

Decision

P/0133/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for etelcalcetide (Parsabiv), (EMEA-001554-PIP01-13-M03)

Adopted Reference Number: P/0133/2022