EMEA-001613-PIP03-21-M01 - paediatric investigation plan

tezepelumab

Key facts

• Invented name:
  Tezspire
• Active substance:
  tezepelumab
• Therapeutic area:
  Gastrointestinal disorders
• Decision number:
  P/0281/2024
• PIP number:
  EMEA-001613-PIP03-21-M01
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of eosinophilic esophagitis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/08/2024
• Compliance check done:
  Nej

Decision

P/0281/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for tezepelumab (Tezspire), (EMEA-001613-PIP03-21-M01)

Adopted Reference Number: EMA/343190/2024