EMEA-003423-PIP01-23 - paediatric investigation plan

volrustomig

Key facts

• Active substance:
  volrustomig
• Therapeutic area:
  Oncology
• Decision number:
  P/0293/2023
• PIP number:
  EMEA-003423-PIP01-23
• Pharmaceutical form(s):
  Concentrate for solution for injection/infusion
• Condition(s) / indication(s):
  • Treatment of cervical cancer
  • Treatment of lung cancer
  • Treatment of mesothelioma
  • Treatment of renal cell carcinoma (RCC)
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/08/2023
• Compliance check done:
  No

Decision

P/0293/2023 : EMA decision of 4 August 2023 on the refusal of a paediatric investigation plan and on the granting of a waiver for volrustomig (EMEA- 003423-PIP01-23)

Reference Number: EMA/339337/2023