EMEA-002606-PIP02-19 - paediatric investigation plan

Bispecific T-cell engager antibody with a single-chain fragment crystallizable moiety that binds to B cell maturation antigen surface receptor on tumour cells and the cluster of differentiation 3 receptor on Tcells

Key facts

• Active substance:
  Bispecific T-cell engager antibody with a single-chain fragment crystallizable moiety that binds to B cell maturation antigen surface receptor on tumour cells and the cluster of differentiation 3 receptor on Tcells
• Therapeutic area:
  • Haematology-Hemostaseology
  • Oncology
• Decision number:
  P/0015/2020
• PIP number:
  EMEA-002606-PIP02-19
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  Treatment of Multiple Myeloma
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  06/01/2020
• Compliance check done:
  No

Decision

P/0015/2020: EMA decision of 6 January 2020 on the granting of a product specific waiver for bispecific T-cell engager antibody with a single-chain fragment crystallizable moiety that binds to B cell maturation antigen surface receptor on tumour cells...

Adopted Reference Number: EMA/672673/2019