EMEA-002503-PIP01-18 - paediatric investigation plan

Glu-NH-CO-NH-Lys-(Ahx)-[N,N9-bis[2-hydroxy-5-(carboxyethyl) benzyl]ethylenediamine-N,N9-diacetic acid (PSMA11-HBED-CC) (HBED Trasis)

Key facts

• Invented name:
  HBED Trasis
• Active substance:
  Glu-NH-CO-NH-Lys-(Ahx)-[N,N9-bis[2-hydroxy-5-(carboxyethyl) benzyl]ethylenediamine-N,N9-diacetic acid (PSMA11-HBED-CC) (HBED Trasis)
• Therapeutic area:
  Oncology
• Decision number:
  P/0208/2019
• PIP number:
  EMEA-002503-PIP01-18
• Pharmaceutical form(s):
  Kit for radiopharmaceutical preparation
• Condition(s) / indication(s):
  Visualisation of prostate specific membrane antigen in prostate 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:
  12/06/2019
• Compliance check done:
  No

Decision

P/0208/2019: EMA decision of 12 June 2019 on the granting of a product specific waiver for Glu-NH-CO-NH-Lys-(Ahx)-[N,N9-bis[2-hydroxy-5-(carboxyethyl) benzyl]ethylenediamine-N,N9-diacetic acid (PSMA11-HBED-CC) (HBED Trasis), (EMEA-002503-PIP01-18)

Adopted Reference Number: EMA/275977/2019