EMEA-003051-PIP05-22 - paediatric investigation plan

Depemokimab

Key facts

• Active Substance:
  Depemokimab
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0040/2023
• PIP number:
  EMEA-003051-PIP05-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of hypereosinophilic syndrome
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  GlaxoSmithKline Trading Services Limited

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  06/02/2023

Decision

P/0040/2023 : EMA decision of 6 February 2023 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-PIP05-22)

Reference Number: EMA/950365/2022