EMEA-000980-PIP04-18 - paediatric investigation plan

Brentuximab vedotin

Key facts

• Invented name:
  • Adcetris
  • Adcetris
• Active substance:
  Brentuximab vedotin
• Therapeutic area:
  Oncology
• Decision number:
  P/0327/2018
• PIP number:
  EMEA-000980-PIP04-18
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of Mature T and NK neoplasms (excluding anaplastic large-cell lymphoma and cutaneous Tcell lymphoma)
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/10/2018
• Compliance check done:
  Níl

Decision

P/0327/2018: EMA decision of 8 October 2018 on the granting of a product specific waiver for brentuximab vedotin (Adcetris), (EMEA-000980-PIP04-18)

Adopted Reference Number: EMA/646757/2018