EMEA-002299-PIP01-17 - paediatric investigation plan

Enfortumab vedotin

Key facts

• Active substance:
  Enfortumab vedotin
• Therapeutic area:
  Oncology
• Decision number:
  P/0114/2018
• PIP number:
  EMEA-002299-PIP01-17
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of urothelial carcinoma
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/04/2018
• Compliance check done:
  Nej

Decision

P/0114/2018: EMA decision of 11 April 2018 on the granting of a product specific waiver for enfortumab vedotin (EMEA-002299-PIP01-17)

Adopted Reference Number: EMA/152182/2018 Corr.