EMEA-001613-PIP03-21 - paediatric investigation plan

tezepelumab

Key facts

• Invented name:
  Tezspire
• Active Substance:
  tezepelumab
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0407/2023
• PIP number:
  EMEA-001613-PIP03-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of eosinophilic esophagitis
• 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:
  25/10/2023

Decision

P/0407/2023 : EMA decision of 25 October 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tezepelumab (Tezspire), (EMEA-001613-PIP03-21)

AdoptedReference Number: EMA/469059/2023