EMEA-001157-PIP01-11-M02 - paediatric investigation plan

Caplacizumab

Key facts

• Active substance:
  Caplacizumab
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0294/2018
• PIP number:
  EMEA-001157-PIP01-11-M02
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of thrombotic thrombocytopenic purpura (TTP)
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/09/2018
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001157-PIP01-11-M02
• Compliance opinion date:
  23/08/2019
• Compliance outcome:
  Positive

Decision

P/0294/2018: EMA decision of 12 September 2018 on the acceptance of a modification of an agreed paediatric investigation plan for caplacizumab (EMEA-001157-PIP01-11-M02)

Adopted Reference Number: EMA/584742/2018