EMA/PE/0000234980 - paediatric investigation plan

human IgG1 monoclonal antibody against prostate specific membrane antigen conjugated to opadotin

Key facts

• Active substance:
  human IgG1 monoclonal antibody against prostate specific membrane antigen conjugated to opadotin
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000234980
• PIP number:
  EMA/PE/0000234980
• 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:
  15/04/2025
• Compliance check done:
  No

Decision

EMA/PE/0000234980: EMA decision of 15 April 2025 on the granting of a product specific waiver for human IgG1 monoclonal antibody against prostate specific membrane antigen conjugated to opadotin

Adopted Reference Number: EMADOC-1700519818-2039231