MHRA-100218-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • DUPILUMAB
Invented Name
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
PIP Number MHRA-100218-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection in a pre-filled syringe
Therapeutic area
Therapeutic area:
  • Dermatology
Conditions / Indications
Conditions / Indications:
  • Chronic spontaneous urticaria
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
19/07/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-100218-PIP01-21-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):DUPILUMAB.pdf
Published Date 15/08/2024