EMEA-003434-PIP02-23 - 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:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0173/2024
• PIP number:
  EMEA-003434-PIP02-23
• Pharmaceutical form(s):
  Dispersion for injection
• Condition(s) / indication(s):
  • Treatment of cutaneous squamous cell carcinoma
  • Treatment of renal cell carcinoma (RCC)
  • Treatment of urothelial carcinoma
• Route(s) of administration:
  Intramuscular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  03/05/2024
• Compliance check done:
  No

Decision

P/0173/2024: EMA decision of 3 May 2024 on the granting of a product specific waiver for modified messenger ribonucleic acid encoding individual patient-specific tumour neoantigens (V940/mRNA-4157), (EMEA-003434-PIP02-23)

Adopted Reference Number: EMA/182128/2024