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01 1F.Hoffmann-La Roche Ltd

02 1Roche Pharma (Switzerland) Ag

03 1Roche Registration GmbH

04 4Roche Registration Gmbh

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PharmaCompass

01

IPPE
Not Confirmed
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IPPE
Not Confirmed

Obinutuzumab

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

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02

IPPE
Not Confirmed
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IPPE
Not Confirmed

Obinutuzumabum

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

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03

IPPE
Not Confirmed
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IPPE
Not Confirmed

obinutuzumab

Brand Name : Gazyva®

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 1000mg

Packaging :

Approval Date : 06-05-2022

Application Number :

Regulatory Info :

Registration Country : Moldova

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04

IPPE
Not Confirmed
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IPPE
Not Confirmed

Obinutuzumab

Brand Name : Gazyvaro

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 1000mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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05

IPPE
Not Confirmed
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IPPE
Not Confirmed

Obinutuzumab

Brand Name : Gazyvaro

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 25mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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06

IPPE
Not Confirmed
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IPPE
Not Confirmed

Obinutuzumab

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

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07

IPPE
Not Confirmed
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IPPE
Not Confirmed

Obinutuzumab

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

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