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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):OBINUTUZUMAB.pdf
Published Date 24/08/2023