MHRA-100100-PIP01-21

Key Facts

Active Substance
Active Substance:
  • Human Immunoglobulin G1 Constant Region – Human Ectodysplasin-A1 Receptor-binding Domain Fusion Protein
Invented Name
Not yet available
PIP Number MHRA-100100-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Dermatology
Conditions / Indications
Conditions / Indications:
  • Treatment of X-linked hypohidrotic ectodermal dysplasia (XLHED)
Route(s) of administration
Route(s) of administration:
  • Intraamniotic 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):Human Immunoglobulin G1 Constant Region ? Human Ectodysplasin-A1 Receptor-binding Domain Fusion Protein.pdf
Published Date 29/07/2022