EMA/PE/0000273488 - paediatric investigation plan

rocatinlimab

Key facts

• Active substance:
  rocatinlimab
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  P/0264/2023
• PIP number:
  EMA/PE/0000273488
• 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:
  02/10/2025
• Compliance check done:
  No

Decision

EMA/PE/0000273488 : EMA decision of 2 October 2025 on the acceptance of a modification of an agreed paediatric investigation plan for rocatinlimab

Adopted Reference Number: EMADOC-1700519818-2468453