EMA/PE/0000240018 - paediatric investigation plan

tezepelumab

Key facts

• Active substance:
  tezepelumab
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  EMA/PE/0000240018
• PIP number:
  EMA/PE/0000240018
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of asthma
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/04/2025
• Compliance check done:
  Ei

Decision

EMA/PE/0000240018 : EMA decision of 16 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for tezepelumab (Tezspire)

Adopted Reference Number: EMADOC-1700519818-2008462