EMEA-001207-PIP02-19-M01

Table of contents

Key facts

Invented name
Gazyvaro
Active substance
Obinutuzumab
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0296/2022
PIP number
EMEA-001207-PIP02-19-M01
Pharmaceutical form(s)
Concentrate for solution for infusion
Condition(s) / indication(s)
Treatment of Systemic Lupus Erythematosus (SLE)
Route(s) of administration
Intravenous use
Contact for public enquiries
Roche Registration GmbH

Tel. +41 616879411
E-mail: info.paediatrics@roche.com

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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