EMEA-002834-PIP01-20 - paediatric investigation plan

Allogeneic B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell

Key facts

• Active Substance:
  Allogeneic B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell
• Therapeutic area:
  Oncology
• Decision number:
  P/0438/2020
• PIP number:
  EMEA-002834-PIP01-20
• Pharmaceutical form(s):
  Dispersion for injection
• Condition(s) / indication(s):
  Treatment of Multiple Myeloma
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  CRISPR Therapeutics AG

  Email: [e-mail]; Tel. [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/12/2020

Decision

P/0438/2020 : EMA decision of 1 December 2020 on the granting of a product specific waiver for allogeneic B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (EMEA-002834-PIP01-20)

AdoptedReference Number: EMA/599202/2020