EMA/PE/0000234649 - paediatric investigation plan

pasritamig

Key facts

• Active substance:
  pasritamig
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000234649
• PIP number:
  EMA/PE/0000234649
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Concentrate for solution for injection
• Condition(s) / indication(s):
  Treatment of prostate malignant neoplasms
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/06/2025
• Compliance check done:
  Nu

Decision

EMA/PE/0000234649 : EMA decision of 12 June 2025 on the granting of a product specific waiver for pasritamig

Adopted Reference Number: EMADOC-1700519818-2194884