MHRA-100455-PIP01-22-M02 (update)

Key Facts

Active Substance
Active Substance:
  • IXAZOMIB
Invented Name
  • Ninlaro
  • Ninlaro
  • Ninlaro
  • Ninlaro
  • Ninlaro
  • Ninlaro
PIP Number MHRA-100455-PIP01-22-M02 (update)
Pharmaceutical form(s)
  • Capsule, hard
  • Powder for solution for injection
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
  • Treatment of multiple myeloma
  • Treatment of lymphoid malignancies (excluding multiple myeloma)
Route(s) of administration
  • Oral use
  • Gastric use
  • Intravenous 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
07/10/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100455-PIP01-22-M02-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):IXAZOMIB.pdf
Published Date 01/05/2026