MHRA-100823-PIP01-22-M02 (update)

Key Facts

Active Substance
Active Substance:
  • Recombinant Human A Disintegrin and Metalloprotease with Thrombospondin Type-1 Motifs 13 (rADAMTS13)
Invented Name
Not available at present
PIP Number MHRA-100823-PIP01-22-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder and solvent for solution for injection
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
Conditions / Indications:
  • Treatment of thrombotic thrombocytopenic purpura.
Route(s) of administration
Route(s) of administration:
  • intravenous
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
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):Recombinant Human A Disintegrin and Metalloprotease with Thrombospondin Type-1Motifs 13 (rADAMTS13).pdf
Published Date 15/08/2024