MHRA-100401-PIP01-21

Key Facts

Active Substance
Active Substance:
  • Humanised IgG2k Fc-modified bispecific antibody against CD3 and BCMA (PF-06863135)
Invented Name
Not yet available
PIP Number MHRA-100401-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of multiple myeloma
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Humanised IgG2k Fc-modified bispecific antibody against CD3 and BCMA (PF-06863135).pdf
Published Date 07/12/2022