EMEA-003461-PIP01-23 - paediatric investigation plan

humanised IgG1 monoclonal antibody against TROP2, conjugated to a topoisomerase I inhibitor belotecan-derivative

Key facts

• Active substance:
  humanised IgG1 monoclonal antibody against TROP2, conjugated to a topoisomerase I inhibitor belotecan-derivative
• Therapeutic area:
  Oncology
• Decision number:
  P/0429/2023
• PIP number:
  EMEA-003461-PIP01-23
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  • Treatment of breast cancer
  • Treatment of cervical cancer
  • Treatment of endometrial cancer
  • Treatment of gastric cancer
  • Treatment of lung cancer
  • Treatment of ovarian cancer
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/10/2023
• Compliance check done:
  No

Decision

P/0429/2023 : EMA decision of 27 October 2023 on the granting of a product specific waiver for humanised IgG1 monoclonal antibody against TROP2, conjugated to a topoisomerase I inhibitor belotecan-derivative, (EMEA-003461-PIP01-23)

Adopted Reference Number: EMA/469858/2023