EMEA-002777-PIP01-20 - paediatric investigation plan

sasanlimab

Key facts

• Active substance:
  sasanlimab
• Therapeutic area:
  Oncology
• Decision number:
  P/0290/2020
• PIP number:
  EMEA-002777-PIP01-20
• Pharmaceutical form(s):
  • Solution for injection
  • Solution for injection in pre-filled syringe
• Condition(s) / indication(s):
  Treatment of ureter and bladder carcinoma
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/08/2020
• Compliance check done:
  No

Decision

P/0290/2020 : EMA decision of 12 August 2020 on the granting of a product specific waiver for sasanlimab (EMEA-002777-PIP01-20)

Adopted Reference Number: EMA/377760/2020