EMEA-001160-PIP01-11-M05 - paediatric investigation plan

recombinant human A disintegrin and metalloprotease with thrombospind type-1 motifs 13

Key facts

• Invented name:
  Adzynma
• Active substance:
  recombinant human A disintegrin and metalloprotease with thrombospind type-1 motifs 13
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  P/0383/2024
• PIP number:
  EMEA-001160-PIP01-11-M05
• Pharmaceutical form(s):
  Powder and solvent for solution for infusion
• Condition(s) / indication(s):
  Treatment of thrombotic thrombocytopenic purpura (TTP)
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  25/10/2024
• Compliance check done:
  No

Decision

P/0383/2024: EMA decision of 24 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant human A disintegrin and metalloprotease with thrombospondin type-1 Motifs 13 (Adzynma), (EMEA-001160- PIP01-11-M05)

Adopted Reference Number: EMA/484938/2024