MHRA-100225-PIP01-21-M01 (update)

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • recombinant parathyroid hormone
Invented Name
  • Natpar
  • Natpar
PIP Number MHRA-100225-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder and solvent for solution for injection
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
Conditions / Indications:
  • Treatment of hypoparathyroidism
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
  • Takeda Pharmaceuticals International AG Ireland Branch
  • Country Ireland
  • Tel +80066838470
  • Email medinfoEMEA@takeda.com
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):recombinant parathyroid hormone.pdf
Published Date 02/02/2023