EMEA-003089-PIP02-23 - paediatric investigation plan

dazukibart

Key facts

• Active substance:
  dazukibart
• Therapeutic area:
  Musculoskeletal and connective tissue disorders
• Decision number:
  P/0377/2024
• PIP number:
  EMEA-003089-PIP02-23
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of idiopathic inflammatory myopathies
• Route(s) of administration:
  Parenteral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  24/10/2024
• Compliance check done:
  No

Decision

P/0377/2024 : EMA decision of 24 October 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for dazukibart (EMEA-003089-PIP02-23)

Adopted Reference Number: EMA/484648/2024