EMEA-000980-PIP01-10-M07 - paediatric investigation plan

Brentuximab vedotin

Key facts

• Invented name:
  Adcetris
• Active substance:
  Brentuximab vedotin
• Therapeutic area:
  Oncology
• Decision number:
  P/0013/2021
• PIP number:
  EMEA-000980-PIP01-10-M07
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  • Treatment of anaplastic large cell lymphoma
  • Treatment of Hodgkin lymphoma
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/01/2021
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-000980-PIP01-10-M07
• Compliance opinion date:
  25/06/2021
• Compliance outcome:
  Positive

Decision

P/0013/2021: EMA decision of 28 January 2021 on the acceptance of a modification of an agreed paediatric investigation plan for brentuximab vedotin (Adcetris), (EMEA-000980-PIP01-10-M07)

Adopted Reference Number: EMA/694485/2020