EMA/PE/0000239491 - paediatric investigation plan

IgG1 trispecific monoclonal antibody against T-cell receptor CD3, B-cell maturation antigen and G protein-coupled receptor class C group 5 member D

Key facts

• Active substance:
  IgG1 trispecific monoclonal antibody against T-cell receptor CD3, B-cell maturation antigen and G protein-coupled receptor class C group 5 member D
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  EMA/PE/0000239491
• PIP number:
  EMA/PE/0000239491
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of Multiple Myeloma
• Route(s) of administration:
  All routes of administration
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  16/05/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000239491 : EMA decision of 16 May 2025 on the granting of a product specific waiver for IgG1 trispecific monoclonal antibody against T-cell receptor CD3, B-cell maturation antigen and G protein-coupled receptor class C group 5 member D

Adopted Reference Number: EMADOC-1700519818-2116079