MHRA-100674-PIP01-22-M02 (update)

Key Facts

Active Substance
Active Substance:
  • DARATUMUMAB
Invented Name
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • DARZALEX FASPRO
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • DARZALEX FASPRO
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
PIP Number MHRA-100674-PIP01-22-M02 (update)
Pharmaceutical form(s)
  • Concentrate for solution for infusion
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of lymphoid malignancies (except mature B-cell neoplasms)
Route(s) of administration
  • Intravenous use
  • 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
Yes
Compliance Check Decision Date
Compliance opinion date
23/10/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100674-PIP01-22-M02 -C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):DARATUMUMAB.pdf
Published Date 15/07/2026