EMEA-002615-PIP01-19 - paediatric investigation plan

A fully humanized immunoglobulin G4 proline, alanine, alanine (IgG4 PAA) based bispecific antibody directed against cluster of differentiation 3 (CD3) receptor complex and G Protein Coupled Receptor Family C Group 5 Member D (GPRC5D) (JNJ-64407564)

Key facts

• Active Substance:
  A fully humanized immunoglobulin G4 proline, alanine, alanine (IgG4 PAA) based bispecific antibody directed against cluster of differentiation 3 (CD3) receptor complex and G Protein Coupled Receptor Family C Group 5 Member D (GPRC5D) (JNJ-64407564)
• Therapeutic area:
  Oncology
• Decision number:
  P/0395/2019
• PIP number:
  EMEA-002615-PIP01-19
• Pharmaceutical form(s):
  Solution for injection/infusion
• Condition(s) / indication(s):
  Treatment of Multiple Myeloma
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/12/2019

Decision

P/0395/2019: EMA decision of 4 December 2019 on the granting of a product specific waiver for a fully humanized immunoglobulin G4 proline, alanine, alanine (IgG4 PAA) based bispecific antibody directed against cluster of differentiation 3 (CD3) receptor c

AdoptedReference Number: EMA/621656/2019