EMA/PE/0000227611 - paediatric investigation plan

sacituzumab tirumotecan

Key facts

• Active substance:
  sacituzumab tirumotecan
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000227611
• PIP number:
  EMA/PE/0000227611
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of urothelial carcinoma
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  19/03/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000227611 : EMA decision of 19 March 2025 on the granting of a product specific waiver for sacituzumab tirumotecan

Adopted Reference Number: EMADOC-1700519818-1973583