MHRA-101454-PIP01-24-M01 (update)

Key Facts

Active Substance
Active Substance:
  • Donidalorsen
Invented Name
Not yet available
PIP Number MHRA-101454-PIP01-24-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
  • Pneumology - Allergology
  • Haematology-Hemostaseology
Conditions / Indications
Conditions / Indications:
  • Treatment of hereditary angioedema
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 Check Procedure Number
Compliance procedure number
MHRA-101454-PIP01-24-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Donidalorsen.pdf
Published Date 11/09/2025