EMEA-001160-PIP01-11-M03 - paediatric investigation plan

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

Key facts

• Active Substance:
  Recombinant human A disintegrin and metalloprotease with thrombospind type-1 motifs 13
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0489/2022
• PIP number:
  EMEA-001160-PIP01-11-M03
• 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
• Contact for public enquiries:

  Takeda Pharmaceuticals International AG Ireland Branch

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  02/12/2022

Decision

P/0489/2022: EMA decision of 2 December 2022 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 (EMEA-001160-PIP01-11- M03)

AdoptedReference Number: EMA/871491/2022 Corr