EMA/PE/0000228097 - paediatric investigation plan

sacituzumab govitecan

Key facts

• Invented name:
  Trodelvy
• Active substance:
  sacituzumab govitecan
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000228097
• PIP number:
  EMA/PE/0000228097
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of endometrial 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:
  28/01/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000228097 : EMA decision of 28 January 2025 on the granting of a product specific waiver for sacituzumab govitecan (Trodelvy)

Adopted Reference Number: EMADOC-1700519818-1854497