EMA/PE/0000237903 - paediatric investigation plan

padeliporfin di-potassium

Key facts

• Active substance:
  padeliporfin di-potassium
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000237903
• PIP number:
  EMA/PE/0000237903
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of upper tract urothelial 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:
  16/04/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000237903 : EMA decision of 16 April 2025 on the granting of a product specific waiver for padeliporfin (dipotassium)

Adopted Reference Number: EMADOC-1700519818-2008916