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    Dabrafenib Mesylate

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    01 29Novartis Pharmaceuticals Corporation

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    01

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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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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    Regulatory Info : RX

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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

    Regulatory Info : RX

    Registration Country : USA

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    DABRAFENIB MESYLATE

    Brand Name : TAFINLAR

    Dosage Form : TABLET, FOR SUSPENSION;ORAL

    Dosage Strength : EQ 10MG BASE

    Packaging :

    Approval Date : 2023-03-16

    Application Number : 217514

    Regulatory Info : RX

    Registration Country : USA

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    Regulatory Info :

    Registration Country : USA

    DABRAFENIB MESYLATE

    Brand Name : TAFINLAR

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 75MG

    Packaging :

    Approval Date :

    Application Number : 217514

    Regulatory Info :

    Registration Country : USA

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    Regulatory Info :

    Registration Country : USA

    DABRAFENIB MESYLATE

    Brand Name : TAFINLAR

    Dosage Form : TABLET; ORAL SUSPENSION

    Dosage Strength : 10MG

    Packaging :

    Approval Date :

    Application Number : 217514

    Regulatory Info :

    Registration Country : USA

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    Regulatory Info :

    Registration Country : Norway

    Dabrafenibmesilat

    Brand Name : Finley

    Dosage Form : Dispersible tablet

    Dosage Strength : 10 mg

    Packaging : Boks 2 210item

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    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    Regulatory Info : Authorized

    Registration Country : Spain

    Dabrafenib Mesylate

    Brand Name : Tafinlar

    Dosage Form : Hard Capsule

    Dosage Strength : 50MG

    Packaging :

    Approval Date : 2014-02-26

    Application Number : 113865001

    Regulatory Info : Authorized

    Registration Country : Spain

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    Regulatory Info : Authorized

    Registration Country : Spain

    Dabrafenib Mesylate

    Brand Name : Tafinlar

    Dosage Form : Hard Capsule

    Dosage Strength : 75MG

    Packaging :

    Approval Date : 2013-09-30

    Application Number : 113865003

    Regulatory Info : Authorized

    Registration Country : Spain

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    Regulatory Info : Authorized

    Registration Country : Spain

    Dabrafenib Mesylate

    Brand Name : Finlee

    Dosage Form : Dispersible Tablet

    Dosage Strength : 10MG

    Packaging :

    Approval Date : 2024-04-12

    Application Number : 1231767001

    Regulatory Info : Authorized

    Registration Country : Spain

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    Regulatory Info : Prescription

    Registration Country : Canada

    DABRAFENIB (DABRAFENIB MESYLATE)

    Brand Name : TAFINLAR

    Dosage Form : CAPSULE

    Dosage Strength : 50MG

    Packaging : 120

    Approval Date :

    Application Number : 2409607

    Regulatory Info : Prescription

    Registration Country : Canada

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    Regulatory Info : Prescription

    Registration Country : Canada

    DABRAFENIB (DABRAFENIB MESYLATE)

    Brand Name : TAFINLAR

    Dosage Form : CAPSULE

    Dosage Strength : 75MG

    Packaging : 120

    Approval Date :

    Application Number : 2409615

    Regulatory Info : Prescription

    Registration Country : Canada

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    Regulatory Info : Prescription

    Registration Country : Canada

    DABRAFENIB (DABRAFENIB MESYLATE)

    Brand Name : TAFINLAR

    Dosage Form : TABLET FOR SUSPENSION

    Dosage Strength : 10MG

    Packaging :

    Approval Date :

    Application Number : 2540053

    Regulatory Info : Prescription

    Registration Country : Canada

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    Regulatory Info :

    Registration Country : Australia

    Dabrafenib

    Brand Name : Tafinlar

    Dosage Form :

    Dosage Strength :

    Packaging : 120

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    Regulatory Info :

    Registration Country : Australia

    Dabrafenib

    Brand Name : Tafinlar

    Dosage Form :

    Dosage Strength :

    Packaging : 120

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    Registration Country : Australia

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    Brand Name : Tafinlar

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    Dosage Strength :

    Packaging : 120

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    Regulatory Info :

    Registration Country : Australia

    Dabrafenib

    Brand Name : Tafinlar

    Dosage Form :

    Dosage Strength :

    Packaging : 420

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    Packaging : 420

    Approval Date :

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    Regulatory Info :

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    Brand Name : Tafinlar

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    Novartis South Africa (Pty) Ltd

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    Regulatory Info : Originator

    Registration Country : South Africa

    Dabrafenib

    Brand Name : Rafinlar 75 mg

    Dosage Form : CAP

    Dosage Strength : 75mg

    Packaging : 120X1mg

    Approval Date :

    Application Number :

    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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