EMEA-002978-PIP02-24 - paediatric investigation plan

trastuzumab deruxtecan

Key facts

• Invented name:
  Enhertu
• Active substance:
  trastuzumab deruxtecan
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0397/2024
• PIP number:
  EMEA-002978-PIP02-24
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of all conditions in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
• 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:
  05/12/2024
• Compliance check done:
  Nu

Decision

P/0397/2024: EMA decision of 5 December 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for trastuzumab deruxtecan (Enhertu), (EMEA-002978-PIP02-24)

Adopted Reference Number: EMA/556006/2024