EMEA-002650-PIP01-19 - paediatric investigation plan

Humanized immunoglobulin (lg) G4 proline, alanine, alanine (IgG4 PAA) based bispecific antibody directed against cluster of differentiation (CD) 3 receptor complex and B-cell maturation antigen (BCMA)

Key facts

• Active substance:
  Humanized immunoglobulin (lg) G4 proline, alanine, alanine (IgG4 PAA) based bispecific antibody directed against cluster of differentiation (CD) 3 receptor complex and B-cell maturation antigen (BCMA)
• Therapeutic area:
  Oncology
• Decision number:
  P/0044/2020
• PIP number:
  EMEA-002650-PIP01-19
• Pharmaceutical form(s):
  Solution for injection/infusion
• Condition(s) / indication(s):
  Treatment of Multiple Myeloma
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/01/2020
• Compliance check done:
  No

Decision

P/0044/2020: EMA decision of 29.01.2020 on the granting of a product specific waiver for humanized immunoglobulin (Ig) G4 proline, alanine, alanine (IgG4 PAA) based bispecific antibody directed against cluster of differentiation (CD) 3 receptor complex..

Adopted Reference Number: EMA/27231/2020