EMA/PE/0000182525 - 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:
  Skin and subcutaneous tissue disorders
• Decision number:
  EMA/PE/0000182525
• PIP number:
  EMA/PE/0000182525
• Pharmaceutical form(s):
  Dispersion for injection
• Condition(s) / indication(s):
  Treatment of melanoma
• Route(s) of administration:
  Intramuscular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  06/12/2024
• Compliance check done:
  No

Decision

EMA/PE/0000182525 : EMA decision of 6 December 2024 on the granting of a product specific waiver for modified messenger ribonucleic acid encoding individual patient-specific tumour neoantigens (V940/mRNA-4157)

Adopted Reference Number: EMADOC-1700519818-1784306