EMEA-003063-PIP03-22 - paediatric investigation plan

Vibostolimab

Pembrolizumab

Key facts

• Active Substance:
  • Vibostolimab
  • Pembrolizumab
• Therapeutic area:
  Oncology
• Decision number:
  P/0424/2023
• PIP number:
  EMEA-003063-PIP03-22
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of melanoma
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  27/10/2023

Decision

P/0424/2023 : EMA decision of 27 October 2023 on the agreement of a paediatric investigation plan and on the granting of a waiver for vibostolimab / pembrolizumab (EMEA-003063-PIP03-22)

AdoptedReference Number: EMA/429589/2023