EMEA-001042-PIP02-11 - paediatric investigation plan

recombinant human granulocyte colony stimulating factor coupled with recombinant human albumin fusion protein

Key facts

• Active Substance:
  recombinant human granulocyte colony stimulating factor coupled with recombinant human albumin fusion protein
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/304/2011
• PIP number:
  EMEA-001042-PIP02-11
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  • Treatment of chemotherapy-induced neutropenia
  • Prevention of chemotherapy-induced febrile neutropenia
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  20/12/2011

Decision

P/304/2011: EMA decision of 20 December 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal of a waiver for recombinant human granulocyte colony stimulating facto...

AdoptedReference Number: EMA/953999/2011