EMEA-000980-PIP02-15 - paediatric investigation plan

Brentuximab vedotin

Key facts

• Invented name:
  • Adcetris
  • Adcetris
• Active substance:
  Brentuximab vedotin
• Therapeutic area:
  Oncology
• Decision number:
  P/0168/2015
• PIP number:
  EMEA-000980-PIP02-15
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of Cutaneous T-Cell 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:
  07/08/2015
• Compliance check done:
  No

Decision

P/0168/2015: EMA decision of 7 August 2015 on the granting of a product-specific waiver for brentuximab vedotin (Adcetris), (EMEA-000980-PIP02-15)

Adopted Reference Number: EMA/473694/2015