EMEA-002507-PIP02-19 - paediatric investigation plan

Recombinant human granulocyte colony-stimulating factor – human immunoglobulin Fc fusion protein (rhG-CSF-Fc)

Key facts

• Active Substance:
  Recombinant human granulocyte colony-stimulating factor – human immunoglobulin Fc fusion protein (rhG-CSF-Fc)
• Therapeutic area:
  Oncology
• Decision number:
  P/0414/2020
• PIP number:
  EMEA-002507-PIP02-19
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Prevention of chemotherapy-induced febrile neutropenia
  • Treatment of chemotherapy-induced neutropenia
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Generon (Shanghai) Corporation

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  23/10/2020

Decision

P/0414/2020 : EMA decision of 23 October 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral for recombinant human granulocyte colony-stimulating factor... (EMEA-002507-PIP02-19)

AdoptedReference Number: EMA/538451/2020