MHRA-100687-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • OBINUTUZUMAB
Invented Name
  • Gazyvaro
  • Gazyvaro
PIP Number MHRA-100687-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of systemic lupus erythematosus
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
  • Roche Products Ltd
  • Country United Kingdom
  • Tel 01707361169
  • Email uk.dra@roche.com
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
31/01/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100687-PIP01-22-M01-C1

Decision Document

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