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    Gadolinium Ethoxybenzyl Dtpa

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    01

    Bayer AG

    Germany
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    Regulatory Info : RX

    Registration Country : USA

    GADOXETATE DISODIUM

    Brand Name : EOVIST

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 1.8143GM/10ML (181.43MG/ML)

    Packaging :

    Approval Date : 2008-07-03

    Application Number : 22090

    Regulatory Info : RX

    Registration Country : USA

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    Bayer AG

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    Bayer AG

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    Regulatory Info : RX

    Registration Country : USA

    GADOXETATE DISODIUM

    Brand Name : EOVIST

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 2.72145GM/15ML (181.43MG/ML)

    Packaging :

    Approval Date : 2013-02-04

    Application Number : 22090

    Regulatory Info : RX

    Registration Country : USA

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    Bayer AG

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    Regulatory Info :

    Registration Country : Norway

    Gadolinium Ethoxybenzyl Dtpa

    Brand Name : Primo Shown

    Dosage Form : Injection fluid, resolution in the finished filled syringe

    Dosage Strength : 0.25 mmol/ml

    Packaging : Finish filled syringe of glass

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    Bayer AG

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Disodium Gadoxate

    Brand Name : Primovist mmolml

    Dosage Form : Solution For Injection

    Dosage Strength : 0.25mmol/ml

    Packaging :

    Approval Date : 10/12/2004

    Application Number : 56936

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    05

    Bayer AG

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    Bayer AG

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    Regulatory Info : Approved

    Registration Country : Sweden

    Disodium Gadoxetate

    Brand Name : Primovist

    Dosage Form : Injectable Solution

    Dosage Strength : 0.25mmol/ml

    Packaging :

    Approval Date : 26/03/2004

    Application Number : 20040326000128

    Regulatory Info : Approved

    Registration Country : Sweden

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    06

    Bayer AG

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    Bayer AG

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    Regulatory Info : Approved

    Registration Country : Sweden

    Disodium Gadoxetate

    Brand Name : Primovist

    Dosage Form : Solution For Injection

    Dosage Strength : 0.25mmol/ml

    Packaging :

    Approval Date : 26/03/2004

    Application Number : 20040326000111

    Regulatory Info : Approved

    Registration Country : Sweden

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    07

    Bayer AG

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    Bayer AG

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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Disodium Gadoxetate

    Brand Name : Primograph

    Dosage Form : Injectable Solution

    Dosage Strength : 0.25mmol/ml

    Packaging :

    Approval Date : 26/03/2004

    Application Number : 20040326000142

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    08

    Bayer AG

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    Bayer AG

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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Disodium Gadoxetate

    Brand Name : Primograph

    Dosage Form : Solution For Injection

    Dosage Strength : 0.25mmol/ml

    Packaging :

    Approval Date : 26/03/2004

    Application Number : 20040326000135

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    09

    Bayer AG

    Germany
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    Bayer AG

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    Regulatory Info : Ethical

    Registration Country : Canada

    GADOXETATE DISODIUM

    Brand Name : PRIMOVIST

    Dosage Form : SOLUTION

    Dosage Strength : 181.43MG/ML

    Packaging : 5ML/7.5ML/10ML

    Approval Date :

    Application Number : 2340666

    Regulatory Info : Ethical

    Registration Country : Canada

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    10

    Bayer AG

    Germany
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    Bayer AG

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    Regulatory Info : Originator

    Registration Country : South Africa

    Gadoxetic Acid Disodium

    Brand Name : Primovist

    Dosage Form : SOL

    Dosage Strength : 600mg

    Packaging : 10X1mg/ml

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    11

    Bayer AG

    Germany
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    Bayer AG

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    Regulatory Info : Authorized

    Registration Country : Spain

    Gadoxetate Disodium

    Brand Name : First View

    Dosage Form : Injectable Solution In Pre-Filled Syringe

    Dosage Strength : 0.25MMOL

    Packaging :

    Approval Date : 2005-03-03

    Application Number : 66648

    Regulatory Info : Authorized

    Registration Country : Spain

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    12

    ORIFARM GROUP AS

    Denmark
    The MedTech Conference
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    ORIFARM GROUP AS

    Denmark
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    Regulatory Info : Approved

    Registration Country : Sweden

    Disodium Gadoxetate

    Brand Name : Primovist

    Dosage Form : Solution For Injection

    Dosage Strength : 0.25mmol/ml

    Packaging :

    Approval Date : 14/09/2016

    Application Number : 20150915000092

    Regulatory Info : Approved

    Registration Country : Sweden

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    13

    ORIFARM GROUP AS

    Denmark
    The MedTech Conference
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    ORIFARM GROUP AS

    Denmark
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    Regulatory Info : Approved

    Registration Country : Sweden

    Disodium Gadoxetate

    Brand Name : Primovist

    Dosage Form : Solution For Injection

    Dosage Strength : 0.25mmol/ml

    Packaging :

    Approval Date : 05/12/2018

    Application Number : 20171101000023

    Regulatory Info : Approved

    Registration Country : Sweden

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    14

    ORIFARM GROUP AS

    Denmark
    The MedTech Conference
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    ORIFARM GROUP AS

    Denmark
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    Regulatory Info : Approved

    Registration Country : Sweden

    Disodium Gadoxetate

    Brand Name : Primovist

    Dosage Form : Solution For Injection

    Dosage Strength : 0.25mmol/ml

    Packaging :

    Approval Date : 10/05/2022

    Application Number : 20220119000096

    Regulatory Info : Approved

    Registration Country : Sweden

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