EMEA-002597-PIP06-21 - paediatric investigation plan

Efgartigimod alfa

Key facts

• Active Substance:
  Efgartigimod alfa
• Therapeutic area:
  Neurology
• Decision number:
  P/0443/2021
• PIP number:
  EMEA-002597-PIP06-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of chronic inflammatory demyelinating polyradiculo-neuropathy
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  argenx BV

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/10/2021

Decision

P/0443/2021 : EMA decision of 29 October 2021 on the granting of a product specific waiver for efgartigimod alfa (EMEA-002597-PIP06-21)

AdoptedReference Number: EMA/531663/2021