EMEA-003576-PIP01-24 - paediatric investigation plan

actinium-225-2-(4,7,10-tris-carboxymethyl-1,4,7,10 tetraaza-cyclododec-1-yl)-pentanedioic acid 3- iodo-D-Tyr-D-Phe-D-Lys-OH)-8-oyl-ε-(HO-Glu-ureido-Lys-OH)

Key facts

• Active Substance:
  actinium-225-2-(4,7,10-tris-carboxymethyl-1,4,7,10 tetraaza-cyclododec-1-yl)-pentanedioic acid 3- iodo-D-Tyr-D-Phe-D-Lys-OH)-8-oyl-ε-(HO-Glu-ureido-Lys-OH)
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0193/2024
• PIP number:
  EMEA-003576-PIP01-24
• 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:
  05/06/2024

Decision

P/0193/2024 - EMA decision of 14 June 2024 on the granting of a product specific waiver for actinium-225-2-(4,7,10-tris-carboxymethyl-1,4,7,10 tetraaza-cyclododec-1-yl)-pentanedioic acid 3-iodo-D-Tyr-D-Phe-D-Lys-OH)-8-oyl-ε-(HO-Glu-ureido- Lys-OH) (EMEA..

AdoptedReference Number: EMA/251758/2024