EMEA-002436-PIP01-18 - paediatric investigation plan

germanium (68Ge) chloride

gallium (68Ga) chloride

Key facts

• Active Substance:
  • germanium (68Ge) chloride
  • gallium (68Ga) chloride
• Therapeutic area:
  Other
• Decision number:
  P/0019/2019
• PIP number:
  EMEA-002436-PIP01-18
• Pharmaceutical form(s):
  Radionuclide generator
• Condition(s) / indication(s):
  Radiolabelling agent
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  03/01/2019

Decision

P/0019/2019: EMA decision of 3 January 2019 on the granting of a product specific waiver for Germanium (68Ge) chloride / Gallium (68Ga) chloride (EMEA-002436-PIP01-18)

Adopted