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    Gadofosveset Trisodium

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    01 3Bayer AG

    02 1JV Healthcare Limited

    03 2Lantheus Medical Imaging

    04 1Tmc Pharma Services Limited

    05 1Tmc Pharma Services Ltd.

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    01

    Bayer AG

    Germany
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    Bayer AG

    Germany
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    Regulatory Info : Authorised

    Registration Country : Malta

    Gadoxetic Acid, Disodium

    Brand Name : Primovist

    Dosage Form : Solution For Injection

    Dosage Strength : 0.25MMOL/ML

    Packaging :

    Approval Date : 2005-08-01

    Application Number :

    Regulatory Info : Authorised

    Registration Country : Malta

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    02

    Bayer AG

    Germany
    Cell Bio
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    Bayer AG

    Germany
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    Cell Bio
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    Regulatory Info : Withdrawn

    Registration Country : Malta

    Gadoxetic Acid, Disodium

    Brand Name : Primovist

    Dosage Form : Solution For Injection

    Dosage Strength : 0.25MMOL/ML

    Packaging :

    Approval Date : 2005-08-01

    Application Number :

    Regulatory Info : Withdrawn

    Registration Country : Malta

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    03

    Bayer AG

    Germany
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    Bayer AG

    Germany
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    Regulatory Info : Withdrawn

    Registration Country : Malta

    Gadoxetic Acid, Disodium

    Brand Name : Primovist

    Dosage Form : Solution For Injection

    Dosage Strength : 0.25MMOL/ML

    Packaging :

    Approval Date : 2012-02-16

    Application Number :

    Regulatory Info : Withdrawn

    Registration Country : Malta

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    04

    Lantheus Medical Imaging

    U.S.A
    Cell Bio
    Not Confirmed
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    Lantheus Medical Imaging

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    GADOFOSVESET TRISODIUM

    Brand Name : ABLAVAR

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 2440MG/10ML (244MG/ML)

    Packaging :

    Approval Date : 2008-12-22

    Application Number : 21711

    Regulatory Info : DISCN

    Registration Country : USA

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    05

    Lantheus Medical Imaging

    U.S.A
    Cell Bio
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    Lantheus Medical Imaging

    U.S.A
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    Cell Bio
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    Regulatory Info : DISCN

    Registration Country : USA

    GADOFOSVESET TRISODIUM

    Brand Name : ABLAVAR

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 3660MG/15ML (244MG/ML)

    Packaging :

    Approval Date : 2008-12-22

    Application Number : 21711

    Regulatory Info : DISCN

    Registration Country : USA

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    06

    Tmc Pharma Services Ltd.

    Country
    Cell Bio
    Not Confirmed
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    Tmc Pharma Services Ltd.

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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Gadofosveset Trisodium

    Brand Name : Ablavar

    Dosage Form : Injectable Solution

    Dosage Strength : 0.25mmol/ml

    Packaging :

    Approval Date : 03/10/2005

    Application Number : 20040916000941

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    07

    Tmc Pharma Services Limited

    Country
    Cell Bio
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    Tmc Pharma Services Limited

    Country
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    Cell Bio
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    Regulatory Info : Cancelled

    Registration Country : Spain

    Gadofosveset Trisodium

    Brand Name : Vasovist

    Dosage Form : Injectable Solution

    Dosage Strength : 0.25MMOL

    Packaging :

    Approval Date : 2005-11-22

    Application Number : 05313001

    Regulatory Info : Cancelled

    Registration Country : Spain

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    08

    JV Healthcare Limited

    Country
    Cell Bio
    Not Confirmed
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    JV Healthcare Limited

    Country
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    Cell Bio
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    Regulatory Info : Withdrawn

    Registration Country : Malta

    Gadoxetic Acid, Disodium

    Brand Name : Primovist

    Dosage Form : Solution For Injection

    Dosage Strength : 0.25MMOL/ML

    Packaging :

    Approval Date : 2015-08-30

    Application Number :

    Regulatory Info : Withdrawn

    Registration Country : Malta

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