MHRA-101235-PIP01-23

Key Facts

Active Substance
Active Substance:
  • Humanised monoclonal antibody derivative against fibroblast growth factor receptor 3
Invented Name
Not yet available
PIP Number MHRA-101235-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
Conditions / Indications:
  • Treatment of achondroplasia
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Humanised monoclonal antibody derivative against fibroblast growth factor receptor 3.pdf
Published Date 24/06/2024