EMEA-001102-PIP01-10 - paediatric investigation plan

gallium (68Ga) chloride

germanium (68Ge) chloride

Key facts

• Active Substance:
  • gallium (68Ga) chloride
  • germanium (68Ge) chloride
• Therapeutic area:
  Other
• Decision number:
  P/133/2011
• PIP number:
  EMEA-001102-PIP01-10
• Pharmaceutical form(s):
  Radionuclide generator
• Condition(s) / indication(s):
  Radiolabelling agent
• Route(s) of administration:
  Other use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/06/2011

Decision

P/133/2011: EMA decision of 8 June 2011 on the granting of a product specific waiver for Gallium [68 Ga] Chloride / Germanium [68 Ge] Chloride (EMEA-001102-PIP01-10)

AdoptedReference Number: EMA/418845/2011