MHRA-100514-PIP01-22

Key Facts

Active Substance
Active Substance:
  • Gliadin Protease
Invented Name
Not yet available
PIP Number MHRA-100514-PIP01-22
Pharmaceutical form(s)
  • Tablet
  • Age -appropriate oral dosage form
Therapeutic area
Therapeutic area:
  • Gastroenterology-Hepatology
Conditions / Indications
Conditions / Indications:
  • Treatment of coeliac disease
Route(s) of administration
Route(s) of administration:
  • Oral 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):Gliadin Protease.pdf
Published Date 25/05/2023