EMEA-002385-PIP01-18 - paediatric investigation plan

Eflapegrastim

Key facts

• Active substance:
  Eflapegrastim
• Therapeutic area:
  • Haematology-Hemostaseology
  • Oncology
• Decision number:
  P/0336/2018
• PIP number:
  EMEA-002385-PIP01-18
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of chemotherapy-induced neutropenia
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/10/2018
• Compliance check done:
  No

Decision

P/0336/2018: EMA decision of 8 October 2018 on the refusing of a product specific waiver for eflapegrastim (EMEA-002385-PIP01-18)

Reference Number: EMA/643737/2018