MHRA-100139-PIP01-21

Key Facts

Active Substance
Active Substance:
  • Teplizumab
Invented Name
Not yet available
PIP Number MHRA-100139-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • concentrate solution
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
Conditions / Indications:
  • Prevention or delay of (clinical) type 1 diabetes mellitus
Route(s) of administration
Route(s) of administration:
  • Intravenous 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
Yes
Compliance Check Decision Date
Compliance Check Procedure Number
Compliance procedure number
MHRA-100139-PIP01-21-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Teplizumab.pdf
Published Date 09/10/2024