EMEA-002559-PIP04-21 - paediatric investigation plan

Anti-neonatal Fc receptor human monoclonal antibody

Key facts

• Active Substance:
  Anti-neonatal Fc receptor human monoclonal antibody
• Therapeutic area:
  Neurology
• Decision number:
  P/0419/2021
• PIP number:
  EMEA-002559-PIP04-21
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of chronic inflammatory demyelinating polyradiculo-neuropathy
• 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/0419/2021 / EMA decision of 29 October 2021 on the granting of a product specific waiver for anti-neonatal Fc receptor human monoclonal antibody (EMEA-002559-PIP04-21)

AdoptedReference Number: EMA/535273/2021