EMEA-003353-PIP01-22 - paediatric investigation plan

Lutetium 177-labelled radiohybrid prostate-specific membrane antigen-10.1 ((177Lu) rhPSMA-10.1)

Key facts

• Active substance:
  Lutetium 177-labelled radiohybrid prostate-specific membrane antigen-10.1 ((177Lu) rhPSMA-10.1)
• Therapeutic area:
  Oncology
• Decision number:
  P/0137/2023
• PIP number:
  EMEA-003353-PIP01-22
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of 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:
  14/04/2023
• Compliance check done:
  No

Decision

P/0137/2023 : EMA decision of 14 April 2023 on the granting of a product specific waiver for lutetium 177-labelled radiohybrid prostate-specific membrane antigen-10.1 ((177Lu) rhPSMA-10.1) (EMEA-003353-PIP01-22)

Reference Number: EMA/108921/2023