EMEA-001613-PIP04-21 - paediatric investigation plan

tezepelumab

Key facts

• Active Substance:
  tezepelumab
• Therapeutic area:
  Dermatology
• Decision number:
  P/0355/2022
• PIP number:
  EMEA-001613-PIP04-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of chronic spontaneous urticaria
• 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:
  12/08/2022

Decision

P/0355/2022 : EMA decision of 12 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tezepelumab (EMEA-001613-PIP04-21)

AdoptedReference Number: EMA/676814/2022