MHRA-101326-PIP01-24

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • Human IgG4 monoclonal antibody against BCMA and CD3
Invented Name
Not available at present
PIP Number MHRA-101326-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of multiple myeloma
Route(s) of administration
Route(s) of administration:
  • All routes of administration
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

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Human IgG4 monoclonal antibody against BCMA and CD3.pdf
Published Date 03/10/2024