EMEA-002978-PIP01-21 - paediatric investigation plan

trastuzumab deruxtecan

Key facts

• Invented name:
  Enhertu
• Active substance:
  trastuzumab deruxtecan
• Therapeutic area:
  Oncology
• Decision number:
  P/0275/2021
• PIP number:
  EMEA-002978-PIP01-21
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of lung cancer
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/07/2021
• Compliance check done:
  Не

Decision

P/0275/2021: EMA decision of 8 July 2021 on the granting of a product specific waiver for trastuzumab deruxtecan (Enhertu), (EMEA-002978-PIP01-21)

Reference Number: EMA/359044/2021