EMEA-003257-PIP01-22 - paediatric investigation plan

zilovertamab vedotin

Key facts

• Active Substance:
  zilovertamab vedotin
• Therapeutic area:
  Oncology
• Decision number:
  P/0130/2023
• PIP number:
  EMEA-003257-PIP01-22
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  • Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue)
  • Treatment of malignant neoplasms of haematopoietic and lymphoid tissue
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Merck Sharp & Dohme (Europe) Inc.

  Tel.: [phone]; E-mail: [e-mail]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  13/04/2023

Decision

P/0130/2023 : EMA decision of 13 April 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal of a waiver for zilovertamab vedotin (EMEA-003257-PIP01-22)

Reference Number: EMA/146751/2023