EMEA-002559-PIP07-22 - paediatric investigation plan

Nipocalimab

Key facts

• Active Substance:
  Nipocalimab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0163/2023
• PIP number:
  EMEA-002559-PIP07-22
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Concentrate for solution for injection
• Condition(s) / indication(s):
  Treatment of Sjögren's syndrome
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/05/2023

Decision

P/0163/2023: EMA decision of of 15 May 2023 on the granting of a product specific waiver for nipocalimab (EMEA-002559-PIP07-22)

Reference Number: EMA/160467/2023