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: global.paediatrics@roche.com

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

Decision

P/0296/2022 : EMA decision of 10 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for obinutuzumab (Gazyvaro), (EMEA-001207-PIP02-19-M01)

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