EMEA-003434-PIP01-23 - paediatric investigation plan

modified messenger ribonucleic acid encoding individual patient-specific tumour neoantigens (V940/ mRNA-4157)

Key facts

• Active substance:
  modified messenger ribonucleic acid encoding individual patient-specific tumour neoantigens (V940/ mRNA-4157)
• Therapeutic area:
  Oncology
• Decision number:
  P/0344/2023
• PIP number:
  EMEA-003434-PIP01-23
• Pharmaceutical form(s):
  Dispersion for injection
• Condition(s) / indication(s):
  Treatment of lung cancer
• Route(s) of administration:
  Intramuscular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/09/2023
• Compliance check done:
  No

Decision

P/0344/2023: EMA decision of 8 September 2023 on the granting of a product specific waiver for modified messenger ribonucleic acid encoding individual patient-specific tumour neoantigens (V940/ mRNA-4157) (EMEA-003434-PIP01-23)

Adopted Reference Number: EMA/352010/2023