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    01 2Hikma Pharmaceuticals

    02 14Novartis Pharmaceuticals Australia Pty Limited

    03 21Novartis Pharmaceuticals Corporation

    04 2Novartis South Africa (Pty) Ltd

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    01

    Hikma Pharmaceuticals

    United Kingdom
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    United Kingdom
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    Regulatory Info : DISCN

    Registration Country : USA

    TRAMETINIB DIMETHYL SULFOXIDE

    Brand Name : TRAMETINIB DIMETHYL SULFOXIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 0.5MG

    Packaging :

    Approval Date : 2024-08-06

    Application Number : 219002

    Regulatory Info : DISCN

    Registration Country : USA

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    02

    Hikma Pharmaceuticals

    United Kingdom
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    Hikma Pharmaceuticals

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    Regulatory Info : DISCN

    Registration Country : USA

    TRAMETINIB DIMETHYL SULFOXIDE

    Brand Name : TRAMETINIB DIMETHYL SULFOXIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 2MG

    Packaging :

    Approval Date : 2024-08-06

    Application Number : 219002

    Regulatory Info : DISCN

    Registration Country : USA

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    03

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Regulatory Info : RX

    Registration Country : USA

    TRAMETINIB DIMETHYL SULFOXIDE

    Brand Name : MEKINIST

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 0.5MG

    Packaging :

    Approval Date : 2013-05-29

    Application Number : 204114

    Regulatory Info : RX

    Registration Country : USA

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    04

    Novartis Pharmaceuticals Corporatio...

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    Regulatory Info : DISCN

    Registration Country : USA

    TRAMETINIB DIMETHYL SULFOXIDE

    Brand Name : MEKINIST

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 2013-05-29

    Application Number : 204114

    Regulatory Info : DISCN

    Registration Country : USA

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    05

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Regulatory Info : RX

    Registration Country : USA

    TRAMETINIB DIMETHYL SULFOXIDE

    Brand Name : MEKINIST

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 2MG

    Packaging :

    Approval Date : 2013-05-29

    Application Number : 204114

    Regulatory Info : RX

    Registration Country : USA

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    06

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Regulatory Info : RX

    Registration Country : USA

    TRAMETINIB DIMETHYL SULFOXIDE

    Brand Name : MEKINIST

    Dosage Form : SOLUTION;ORAL

    Dosage Strength : EQ 0.05MG BASE/ML

    Packaging :

    Approval Date : 2023-03-16

    Application Number : 217513

    Regulatory Info : RX

    Registration Country : USA

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    07

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Regulatory Info :

    Registration Country : USA

    TRAMETINIB

    Brand Name : MEKINIST

    Dosage Form : TABLET;ORAL

    Dosage Strength : 2MG

    Packaging :

    Approval Date :

    Application Number : 217513

    Regulatory Info :

    Registration Country : USA

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    08

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Regulatory Info :

    Registration Country : USA

    TRAMETINIB

    Brand Name : MEKINIST

    Dosage Form : SOLUTION;ORAL

    Dosage Strength : 4.7MG

    Packaging :

    Approval Date :

    Application Number : 217513

    Regulatory Info :

    Registration Country : USA

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    09

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Regulatory Info :

    Registration Country : Norway

    Trametinib Dimethyl Sulfoxide

    Brand Name : Spexotras

    Dosage Form : Powder for oral solution, solution

    Dosage Strength : 0.05 mg/ml

    Packaging : Bottle 1item

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    10

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Regulatory Info : Approved

    Registration Country : Sweden

    Trametinib Dimethyl Sulfoxide

    Brand Name : Mekinist

    Dosage Form : Film Coated Tablet

    Dosage Strength : 0.5mg

    Packaging :

    Approval Date : 30/06/2014

    Application Number : 20130212000025

    Regulatory Info : Approved

    Registration Country : Sweden

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    11

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Regulatory Info : Approved

    Registration Country : Sweden

    Trametinib Dimethyl Sulfoxide

    Brand Name : Mekinist

    Dosage Form : Film Coated Tablet

    Dosage Strength : 2mg

    Packaging :

    Approval Date : 30/06/2014

    Application Number : 20130212000056

    Regulatory Info : Approved

    Registration Country : Sweden

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    12

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Regulatory Info : Approved

    Registration Country : Sweden

    Trametinib Dimethyl Sulfoxide

    Brand Name : Specxtras

    Dosage Form : Powder For Oral Solution

    Dosage Strength : 0.05mg/ml

    Packaging :

    Approval Date : 05/01/2024

    Application Number : 20220912000040

    Regulatory Info : Approved

    Registration Country : Sweden

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    13

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Trametinib Dimethyl Sulfoxide

    Brand Name : Mekinist

    Dosage Form : Film Coated Tablet

    Dosage Strength :

    Packaging :

    Approval Date : 30/06/2014

    Application Number : 20130212000049

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    14

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Tramway

    Brand Name : Mekinist

    Dosage Form : Film Coated Tablet

    Dosage Strength : 0.5mg

    Packaging :

    Approval Date : 22/02/2016

    Application Number : 65883

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    15

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Tramway

    Brand Name : Mekinist

    Dosage Form : Film Coated Tablet

    Dosage Strength : 2mg

    Packaging :

    Approval Date : 22/02/2016

    Application Number : 65883

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    16

    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Tramway

    Brand Name : Mekinist

    Dosage Form : Powder For Oral Solution

    Dosage Strength : 4.7mg

    Packaging :

    Approval Date : 05/09/2023

    Application Number : 69134

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    17

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    Regulatory Info : Authorized

    Registration Country : Spain

    Trametinib Dimethyl Sulfoxide

    Brand Name : Spexotras

    Dosage Form : Powder For Oral Solution

    Dosage Strength : 0.05MG

    Packaging :

    Approval Date : 2024-04-10

    Application Number : 1231781001

    Regulatory Info : Authorized

    Registration Country : Spain

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    Regulatory Info : Authorized

    Registration Country : Spain

    Trametinib

    Brand Name : Mekinist

    Dosage Form : Film Coated Tablet

    Dosage Strength : 2MG

    Packaging :

    Approval Date : 2025-03-03

    Application Number : 114931006IP

    Regulatory Info : Authorized

    Registration Country : Spain

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    Regulatory Info : Authorized

    Registration Country : Spain

    Trametinib

    Brand Name : Mekinist

    Dosage Form : Film Coated Tablet

    Dosage Strength : 2MG

    Packaging :

    Approval Date : 2015-09-24

    Application Number : 114931006

    Regulatory Info : Authorized

    Registration Country : Spain

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    Regulatory Info : Authorized

    Registration Country : Spain

    Trametinib

    Brand Name : Mekinist

    Dosage Form : Film Coated Tablet

    Dosage Strength : 0.5MG

    Packaging :

    Approval Date : 2015-09-24

    Application Number : 114931002

    Regulatory Info : Authorized

    Registration Country : Spain

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