EMEA-001042-PIP01-10 - paediatric investigation plan

recombinant human granulocyte colony stimulating factor

recombinant human albumin fusion protein

Key facts

• Active substance:
  • recombinant human granulocyte colony stimulating factor
  • recombinant human albumin fusion protein
• Therapeutic area:
  Oncology
• Decision number:
  P/36/2011
• PIP number:
  EMEA-001042-PIP01-10
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of chemotherapy induced neutropenia
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
• Decision date:
  28/01/2011
• Compliance check done:
  No

Decision

P/36/2011: EMA decision of 28 January 2011 on the refusal of a product specific waiver for recombinant human granulocyte colony stimulating factor / recombinant human albumin fusion protein (EMEA-001042-PIP01-10) in acc...

Adopted Reference Number: EMA/35172/2011