EMEA-001285-PIP01-12-M02 - paediatric investigation plan

Dinutuximab

Key facts

• Invented name:
  • Unituxin
  • Unituxin
• Active substance:
  Dinutuximab
• Therapeutic area:
  Oncology
• Decision number:
  P/0208/2013
• PIP number:
  EMEA-001285-PIP01-12-M02
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of neuroblastoma
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/08/2016
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001285-PIP01-12-M02
• Compliance opinion date:
  16/12/2016
• Compliance outcome:
  Positive

Decision

P/0215/2016: EMA decision of 12 August 2016 on the acceptance of a modification of an agreed paediatric investigation plan for dinutuximab (Unituxin) (EMEA-001285-PIP01-12-M02)

Adopted Reference Number: EMA/472143/2016