Key facts

Invented name
Gazyvaro
Active Substance
Obinutuzumab
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0512/2020
PIP number
EMEA-001207-PIP03-20
Pharmaceutical form(s)
Concentrate for solution for infusion
Condition(s) / indication(s)
Treatment of glomerulonephritis and nephrotic syndrome
Route(s) of administration
Intravenous use
Contact for public enquiries

Roche Registration GmbH

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

Decision type
W: decision granting a waiver in all age groups for all conditions or indications
Decision date

Decision

P/0512/2020 : EMA decision of 22 December 2020 on the refusal of a product specific waiver for obinutuzumab (Gazyvaro) (EMEA-001207-PIP03-20)

How useful do you find this page?