MHRA-100288-PIP01-21-M02 (update)

Key Facts

Active Substance
Active Substance:
  • DENOSUMAB
Invented Name
  • Prolia
  • Prolia
PIP Number MHRA-100288-PIP01-21-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
Conditions / Indications:
  • Treatment of osteoporosis
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
10/03/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100288-PIP01-21-M02-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):DENOSUMAB.pdf
Published Date 14/04/2026