EMEA-003051-PIP04-22 - paediatric investigation plan

Depemokimab

Key facts

• Active Substance:
  Depemokimab
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0543/2022
• PIP number:
  EMEA-003051-PIP04-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of eosinophilic granulomatosis with polyangiitis
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  GlaxoSmithKline Trading Services Limited

  email: [e-mail]; tel: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  30/12/2023

Decision

P/0543/2022 : EMA decision of 30 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for depemokimab (EMEA-003051-PIP04-22)

AdoptedReference Number: EMA/876016/2022