EMEA-002299-PIP02-23 - paediatric investigation plan

Enfortumab vedotin

Key facts

• Invented name:
  Padcev
• Active substance:
  Enfortumab vedotin
• Therapeutic area:
  Oncology
• Decision number:
  P/0385/2023
• PIP number:
  EMEA-002299-PIP02-23
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of head and neck epithelial malignant neoplasms
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/09/2023
• Compliance check done:
  Ei

Decision

P/0385/2023 : EMA decision of 7 September 2023 on the granting of a product specific waiver for enfortumab vedotin (Padcev), (EMEA-002299-PIP02-23)

Reference Number: EMA/389081/2023