EMEA-001526-PIP01-13-M06 - paediatric investigation plan

recombinant parathyroid hormone

Key facts

• Invented name:
  Natpar
• Active substance:
  recombinant parathyroid hormone
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0276/2023
• PIP number:
  EMEA-001526-PIP01-13-M06
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of hypoparathyroidism
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/07/2023
• Compliance check done:
  Nej

Decision

P/0276/2023 : EMA decision of 14 July 2023 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant parathyroid hormone (Natpar), (EMEA-001526-PIP01-13-M06)

Reference Number: EMA/282640/2023