EMEA-003083-PIP01-21 - paediatric investigation plan

Humanised IgG2k Fc-modified bispecific antibody against CD3 and BCMA (PF-06863135)

Key facts

• Active Substance:
  Humanised IgG2k Fc-modified bispecific antibody against CD3 and BCMA (PF-06863135)
• Therapeutic area:
  Oncology
• Decision number:
  P/0564/2021
• PIP number:
  EMEA-003083-PIP01-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of Multiple Myeloma
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Pfizer Europe MA EEIG

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/12/2021

Decision

P/0564/2021 : EMA decision of 31 December 2021 on the granting of a product specific waiver for humanised IgG2k Fc-modified bispecific antibody against CD3 and BCMA (PF-06863135), (EMEA-003083-PIP01-21)

AdoptedReference Number: EMA/649839/2021