EMEA-001089-PIP02-13-M04 - paediatric investigation plan

brodalumab

Key facts

• Invented name:
  Kyntheum
• Active Substance:
  brodalumab
• Therapeutic area:
  Dermatology
• Decision number:
  P/0212/2023
• PIP number:
  EMEA-001089-PIP02-13-M04
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of psoriasis
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  LEO Pharma A/S; Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/06/2023

Decision

P/0212/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for brodalumab (Kyntheum), (EMEA-001089-PIP02-13-M04)

Reference Number: EMA/236234/2023