EMEA-003610-PIP01-24 - paediatric investigation plan

Copper (64Cu) oxodotreotide

Key facts

• Active substance:
  Copper (64Cu) oxodotreotide
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0301/2024
• PIP number:
  EMEA-003610-PIP01-24
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Diagnosis of neuroendocrine tumours (excluding neuroblastoma)
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  16/08/2024
• Compliance check done:
  No

Decision

P/0301/2024: EMA decision of 16 August 2024 on the granting of a product specific waiver for copper (64Cu) oxodotreotide, (EMEA-003610-PIP01- 24)

Adopted Reference Number: EMA/364750/2024