EMEA-002559-PIP08-23 - paediatric investigation plan

Nipocalimab

Key facts

• Active substance:
  Nipocalimab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0272/2023
• PIP number:
  EMEA-002559-PIP08-23
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of idiopathic inflammatory myopathies
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  14/07/2023
• Compliance check done:
  No

Decision

P/0272/2023 : EMA decision of 14 July 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for nipocalimab, (EMEA-002559-PIP08-23)

Reference Number: EMA/251129/2023