EMEA-003040-PIP01-21 - paediatric investigation plan

Izaflortaucipir (18F)

Key facts

• Active Substance:
  Izaflortaucipir (18F)
• Therapeutic area:
  Neurology
• Decision number:
  P/0432/2021
• PIP number:
  EMEA-003040-PIP01-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Diagnosis of corticobasal degeneration
  • Treatment of progressive supranuclear palsy
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/10/2021

Decision

P/0432/2021 : EMA decision of 29 October 2021 on the granting of a product specific waiver for izaflortaucipir (18F) (EMEA-003040-PIP01-21)

AdoptedReference Number: EMA/533649/2021