EMEA-002645-PIP02-20 - paediatric investigation plan

sacituzumab govitecan

Key facts

• Active substance:
  sacituzumab govitecan
• Therapeutic area:
  Oncology
• Decision number:
  P/0398/2020
• PIP number:
  EMEA-002645-PIP02-20
• Pharmaceutical form(s):
  Powder and solvent 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:
  23/10/2020
• Compliance check done:
  No

Decision

P/0398/2020 : EMA decision of 23 October 2020 on the granting of a product-specific waiver for sacituzumab govitecan (EMEA-002645-PIP02-20)

Adopted Reference Number: EMA/494619/2020