EMEA-001842-PIP02-15 - paediatric investigation plan

Gallium (68Ga)

Key facts

• Active substance:
  Gallium (68Ga)
• Therapeutic area:
  Other
• Decision number:
  P/0110/2016
• PIP number:
  EMEA-001842-PIP02-15
• Pharmaceutical form(s):
  • Radiopharmaceutical precursor
  • Solution
• Condition(s) / indication(s):
  Radiolabelling agent
• Route(s) of administration:
  Parenteral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/04/2016
• Compliance check done:
  No

Decision

P/0110/2016: EMA decision of 15 April 2016 on the granting of a product specific waiver for Gallium [68Ga] (EMEA-001842-PIP02-15)

Adopted Reference Number: EMA/188353/2016