MHRA-100750-PIP01-22-M02 (update)

Key Facts

Active Substance
Active Substance:
  • setrusumab
Invented Name
Ozyvyo
PIP Number MHRA-100750-PIP01-22-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for solution for injection
Therapeutic area
Conditions / Indications
Conditions / Indications:
  • Treatment of osteogenesis imperfecta
Route(s) of administration
Route(s) of administration:
  • Intravenous 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
11/05/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-100750-PIP01-22-M02-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):setrusumab.pdf
Published Date 06/07/2026