EMEA-003274-PIP01-22 - paediatric investigation plan

enomimeran

gindameran

ontasameran

vibosameran (BNT111)

Key facts

• Active substance:
  • enomimeran
  • gindameran
  • ontasameran
  • vibosameran (BNT111)
• Therapeutic area:
  Oncology
• Decision number:
  P/0292/2023
• PIP number:
  EMEA-003274-PIP01-22
• Pharmaceutical form(s):
  Dispersion for injection
• 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:
  04/08/2023
• Compliance check done:
  No

Decision

P/0292/2023 : EMA decision of 4 August 2023 on the agreement of a paediatric investigation plan and on the granting of a waiver for enomimeran / gindameran / ontasameran / vibosameran (BNT111), (EMEA-003274-PIP01-22)

Reference Number: EMA/339324/2023