EMA/PE/0000243984 - paediatric investigation plan

disitamab vedotin

Key facts

• Active substance:
  disitamab vedotin
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000243984
• PIP number:
  EMA/PE/0000243984
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of solid tumours, including central nervous system malignancies
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/06/2025
• Compliance check done:
  Nu

Decision

EMA/PE/0000243984 : EMA decision of 13 June 2025 on the acceptance of a modification of an agreed paediatric investigation plan for disitamab vedotin

Adopted Reference Number: EMADOC-1700519818-2145510