EMEA-002464-PIP01-18 - paediatric investigation plan

human immunoglobulin (Ig) G4-variant monoclonal antibody that binds and neutralizes soluble human interleukin (IL-) 33

Key facts

• Active substance:
  human immunoglobulin (Ig) G4-variant monoclonal antibody that binds and neutralizes soluble human interleukin (IL-) 33
• Therapeutic area:
  Dermatology
• Decision number:
  P/0275/2019
• PIP number:
  EMEA-002464-PIP01-18
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of atopic dermatitis
• 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:
  16/08/2019
• Compliance check done:
  No

Decision

P/0275/2019: of 16 August 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for human immunoglobulin (Ig) G4-variant monoclonal antibody that binds... (EMEA-002464-PIP01-18)

Adopted Reference Number: EMA/444284/2019