EMEA-003443-PIP02-23 - paediatric investigation plan

disitamab vedotin

Key facts

• Active substance:
  disitamab vedotin
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0126/2024
• PIP number:
  EMEA-003443-PIP02-23
• 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:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  12/04/2024
• Compliance check done:
  No

Decision

P/0126/2024: EMA decision of on the agreement of 12 April 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for disitamab vedotin (EMEA-003443-PIP02-23)

Adopted Reference Number: EMA/114598/2024