EMEA-000653-PIP01-09-M05 - paediatric investigation plan

romiplostim

Key facts

• Invented name:
  • Nplate
  • Nplate
• Active substance:
  romiplostim
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0233/2017
• PIP number:
  EMEA-000653-PIP01-09-M05
• Pharmaceutical form(s):
  • Powder for solution for injection
  • Powder and solvent for solution for injection
• Condition(s) / indication(s):
  • Treatment of disease-related thrombocytopenia in myelodysplastic syndrome
  • Treatment of idiopathic thrombocytopenic purpura as a model for immunomodulation
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/08/2017
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-000653-PIP01-09-M05
• Compliance opinion date:
  27/03/2020
• Compliance outcome:
  Positive

Decision

P/0233/2017: EMA decision of 11 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for romiplostim (Nplate), (EMEA-000653-PIP01-09-M05)

Adopted Reference Number: EMA/460032/2017