MHRA-100816-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • crovalimab
Invented Name
Not yet available
PIP Number MHRA-100816-PIP01-22-M01 (update)
Pharmaceutical form(s)
  • Solution for infusion
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
  • Treatment of paroxysmal nocturnal haemoglobinuria
  • Treatment of atypical haemolytic uremic syndrome
Route(s) of administration
  • intravenous
  • 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-100816-PIP01-22-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):crovalimab.pdf
Published Date 25/05/2023