EMEA-002727-PIP01-19-M01 - paediatric investigation plan

nivolumab

Relatlimab

Key facts

• Active Substance:
  • nivolumab
  • Relatlimab
• Therapeutic area:
  Oncology
• Decision number:
  P/0070/2021
• PIP number:
  EMEA-002727-PIP01-19-M01
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of melanoma
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/03/2021
• Compliance procedure number:
  EMEA-C-002727-PIP01-19-M01
• Compliance opinion date:
  10/09/2021
• Compliance outcome:
  Positive

Decision

P/0070/2021 : EMA decision of 17 March 2021 on the acceptance of a modification of an agreed paediatric investigation plan for relatlimab / nivolumab (EMEA-002727-PIP01-19-M01)

Reference Number: EMA/71516/2021