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    01 5Novartis Pharmaceuticals Australia Pty Limited

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    Novartis Pharmaceuticals Corporatio...

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    Regulatory Info : RX

    Registration Country : USA

    DABRAFENIB MESYLATE

    Brand Name : TAFINLAR

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : EQ 50MG BASE

    Packaging :

    Approval Date : 2013-05-29

    Application Number : 202806

    Regulatory Info : RX

    Registration Country : USA

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    DABRAFENIB MESYLATE

    Brand Name : TAFINLAR

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : EQ 75MG BASE

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    Approval Date : 2013-05-29

    Application Number : 202806

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    Registration Country : USA

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    DABRAFENIB MESYLATE

    Brand Name : TAFINLAR

    Dosage Form : TABLET, FOR SUSPENSION;ORAL

    Dosage Strength : EQ 10MG BASE

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    Approval Date : 2023-03-16

    Application Number : 217514

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    Registration Country : USA

    DABRAFENIB MESYLATE

    Brand Name : TAFINLAR

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 75MG

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    Approval Date :

    Application Number : 217514

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    Registration Country : USA

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    DABRAFENIB MESYLATE

    Brand Name : TAFINLAR

    Dosage Form : TABLET; ORAL SUSPENSION

    Dosage Strength : 10MG

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    Approval Date :

    Application Number : 217514

    Regulatory Info :

    Registration Country : USA

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    06

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    Dabrafenibmesilat

    Brand Name : Finley

    Dosage Form : Dispergerbar tablett

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    Registration Country : Norway

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    07

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    Dabrafenibum

    Brand Name : Tafinlar

    Dosage Form : Kaps

    Dosage Strength : 50mg

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    Registration Country : Switzerland

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    Dabrafenibum

    Brand Name : Tafinlar

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    Registration Country : Switzerland

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    Dabrafenibum

    Brand Name : Tafinlar

    Dosage Form : Kaps

    Dosage Strength : 75mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    10

    Novartis Pharmaceuticals Corporatio...

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    Registration Country : Switzerland

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    Brand Name : Tafinlar

    Dosage Form : Kaps

    Dosage Strength : 75mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Registration Country : Australia

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    Brand Name : Tafinlar

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    Packaging : 120

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    Regulatory Info :

    Registration Country : Australia

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    Novartis South Africa (Pty) Ltd

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    Registration Country : South Africa

    Dabrafenib

    Brand Name : Rafinlar 75 mg

    Dosage Form : CAP

    Dosage Strength : 75mg

    Packaging : 120X1mg

    Approval Date :

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    Regulatory Info : Originator

    Registration Country : South Africa

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    Regulatory Info : Originator

    Registration Country : South Africa

    Dabrafenib

    Brand Name : Rafinlar 50 mg

    Dosage Form : CAP

    Dosage Strength : 50mg

    Packaging : 120X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Novartis Pharmaceuticals Australia ...

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    Packaging : 120

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    Application Number :

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    Registration Country : Australia

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