MHRA-100674-PIP01-22-M01 (update)

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
Invented Name
  • Darzalex
  • Darzalex
PIP Number MHRA-100674-PIP01-22-M01 (update)
Pharmaceutical form(s)
  • Solution for injection
  • Concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of lymphoid malignancies (except mature B-cell neoplasms)
Route(s) of administration
  • Subcutaneous use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):DARATUMUMAB.pdf
Published Date 25/05/2023