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 1Schedule D
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 : Schedule D
Registration Country : Canada
Brand Name : GAZYVA
Dosage Form : SOLUTION
Dosage Strength : 25MG/ML
Packaging : 40ML
Approval Date :
Application Number : 2434806
Regulatory Info : Schedule D
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 : 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
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Gazyvaro
Dosage Form : Concentrate For Infusion Solution
Dosage Strength : 1000MG
Packaging :
Approval Date : 2014-08-06
Application Number : 114937001
Regulatory Info : Authorized
Registration Country : Spain
