EMEA-002414-PIP01-18 - paediatric investigation plan

Humanized anti-CD19, Fc engineered, monoclonal antibody (XmAb5871)

Key facts

• Active substance:
  Humanized anti-CD19, Fc engineered, monoclonal antibody (XmAb5871)
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0274/2019
• PIP number:
  EMEA-002414-PIP01-18
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of immunoglobulin G4-related disease
• 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:
  Nein

Decision

P/0274/2019: EMA decision 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 humanized anti-CD19, Fc engineered, monoclonal antibody (XmAb5871) (EMEA-002414-PIP01-18)

Adopted Reference Number: EMA/439014/2019 Corr.