01 18F. Hoffmann-La Roche
02 1Genentech
03 2Roche Diagnostics GmbH
01 2Concentrate For Infusion Solution
02 2Concentrate For Solution For Infusion
03 1INF
04 1INJECTABLE;INJECTION
05 1SOLUTION
06 14Blank
01 1Allowed
02 1Approved
03 2Authorized
04 1Originator
05 1Prescription
06 15Blank
01 2GAZYVA
02 15Gazyva
03 4Gazyvaro
01 14Australia
02 1Canada
03 1South Africa
04 2Spain
05 1Sweden
06 1Switzerland
07 1USA
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Gazyvaro
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 1000mg
Packaging :
Approval Date : 23/07/2014
Application Number : 20130530000042
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Gazyvaro
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 1000mg/40ml
Packaging :
Approval Date : 10/06/2014
Application Number : 63172
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : GAZYVA
Dosage Form : SOLUTION
Dosage Strength : 25MG/ML
Packaging : 40ML
Approval Date :
Application Number : 2434806
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Gazyva
Dosage Form : INF
Dosage Strength : 1000mg
Packaging : 40X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : Australia
Brand Name : Gazyva
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Gazyva
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Gazyva
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Gazyva
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Gazyva
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Gazyva
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Gazyva
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Gazyva
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Gazyva
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Gazyva
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Gazyva
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Gazyva
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Gazyva
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Gazyva
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : USA
Brand Name : GAZYVA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 1000MG/40ML
Packaging :
Approval Date :
Application Number : 125486
Regulatory Info :
Registration Country : USA
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Gazyvaro
Dosage Form : Concentrate For Infusion Solution
Dosage Strength : 1000MG
Packaging :
Approval Date : 2021-01-08
Application Number : 114937001IP
Regulatory Info : Authorized
Registration Country : Spain
