EMEA-003340-PIP01-22 - paediatric investigation plan

Upifitamab rilsodotin

Key facts

• Active Substance:
  Upifitamab rilsodotin
• Therapeutic area:
  Oncology
• Decision number:
  P/0083/2023
• PIP number:
  EMEA-003340-PIP01-22
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  • Treatment of fallopian tube cancer
  • Treatment of ovarian cancer
  • Treatment of primary peritoneal cancer
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Mersana Therapeutics Inc; E-mail: [e-mail]; Tel: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/03/2023

Decision

P/0083/2023 : EMA decision of 10 March 2023 on the granting of a product specific waiver for upifitamab rilsodotin (EMEA-003340-PIP01-22)

Reference Number: EMA/37963/2023