EMEA-002559-PIP06-22 - paediatric investigation plan

Nipocalimab

Key facts

• Active Substance:
  Nipocalimab
• Therapeutic area:
  Neurology
• Decision number:
  P/0509/2022
• PIP number:
  EMEA-002559-PIP06-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of chronic inflammatory demyelinating polyradiculoneuropathy
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Janssen Cilag International NV

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  02/12/2022

Decision

P/0509/2022 : EMA decision of 2 December 2022 on the granting of a product specific waiver for nipocalimab (EMEA-002559-PIP06-22)

Reference Number: EMA/898521/2022