EMA/PE/0000221462 - paediatric investigation plan

[225Ac]Ac-PSMA-617

Key facts

• Active substance:
  [225Ac]Ac-PSMA-617
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000221462
• PIP number:
  EMA/PE/0000221462
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of PSMA-expressing prostate cancer
• 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:
  03/01/2025
• Compliance check done:
  No

Decision

EMA/PE/0000221462 : EMA decision of 3 January 2025 on the granting of a product specific waiver for [225Ac]Ac-PSMA-617

Adopted Reference Number: EMADOC-1700519818-1811118