EMEA-002886-PIP03-24 - paediatric investigation plan

rocatinlimab

Key facts

• Active substance:
  rocatinlimab
• Therapeutic area:
  Respiratory, thoracic and mediastinal disorders
• Decision number:
  EMEA-002886-PIP03-24
• PIP number:
  EMEA-002886-PIP03-24
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of asthma
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  03/01/2025
• Compliance check done:
  No

Decision

EMEA-002886-PIP03-24 : EMA decision of 3 January 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for rocatinlimab

Adopted Reference Number: EMA/581540/2024