EMEA-001900-PIP02-17-M08 - paediatric investigation plan

tralokinumab

Key facts

• Invented name:
  Adtralza
• Active substance:
  tralokinumab
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  P/0012/2024
• PIP number:
  EMEA-001900-PIP02-17-M08
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of atopic dermatitis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  31/01/2024
• Compliance check done:
  No

Decision

P/0012/2024 : EMA decision of 31 January 2024 on the acceptance of a modification of an agreed paediatric investigation plan for tralokinumab (Adtralza), (EMEA-001900-PIP02-17-M08)

Adopted Reference Number: EMA/15339/2024