MHRA-100100-PIP01-21

Key Facts

PIPS 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

PIPS Decision Documents
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