EMEA-001261-PIP01-11-M07 - paediatric investigation plan

Eribulin

Key facts

• Invented name:
  • Halaven
  • Halaven
• Active substance:
  Eribulin
• Therapeutic area:
  Oncology
• Decision number:
  P/0535/2021
• PIP number:
  EMEA-001261-PIP01-11-M07
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of soft tissue sarcoma
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  06/12/2021
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-001261-PIP01-11-M07
• Compliance opinion date:
  25/02/2022
• Compliance outcome:
  Positive

Decision

P/0535/2021: EMA decision of 6 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for eribulin (Halaven), (EMEA-001261-PIP01-11-M07)

Adopted Reference Number: EMA/699482/2021