Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1657133
Name of medicinal product: GAZYVARO
Active substances:
Obinutuzumab
Estonian, English, Latin
ATC code: L01FA03
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 25mg 1ml
Amount in package: 40ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Chronic lymphocytic leukaemia (CLL) Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated CLL and with comorbidities making them unsuitable for full-dose fludarabine based therapy (see section 5.1). Follicular lymphoma (FL) Gazyvaro in combination with chemotherapy, followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced FL (see section 5.1) Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: March 31, 2024
Marketing authorization holder: Roche Registration GmbH 
Marketing authorization number: EU/1/14/937 
Marketing authorization issued on: July 24, 2014 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: February 22, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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