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    Cobimetinib

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    01 8F. Hoffmann-La Roche

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    03 1Roche Diagnostics GmbH

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    01

    F. Hoffmann-La Roche

    Switzerland
    ISPE Annual Meeting
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    Switzerland
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    Regulatory Info :

    Registration Country : Italy

    cobimetinib

    Brand Name : Cotellic

    Dosage Form : Cobimetinib 20Mg 63 Combined Oral Use

    Dosage Strength : 3x21 cpr riv 20 mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    02

    F. Hoffmann-La Roche

    Switzerland
    ISPE Annual Meeting
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    Switzerland
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    Regulatory Info :

    Registration Country : Norway

    cobimetinib

    Brand Name : Cotellic

    Dosage Form : Antic-calc Tablet, Film Coated

    Dosage Strength : 20 mg

    Packaging : Blister

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    03

    F. Hoffmann-La Roche

    Switzerland
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Cobimetinub

    Brand Name : Cotellic

    Dosage Form : Film Coated Tablet

    Dosage Strength : 20mg

    Packaging :

    Approval Date : 24/08/2015

    Application Number : 65620

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    04

    F. Hoffmann-La Roche

    Switzerland
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    Regulatory Info : Approved

    Registration Country : Sweden

    Kobimetinibhemifumarat

    Brand Name : Cotellic

    Dosage Form : Film Coated Tablet

    Dosage Strength : 20mg

    Packaging :

    Approval Date : 20/11/2015

    Application Number : 20140904000011

    Regulatory Info : Approved

    Registration Country : Sweden

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    05

    F. Hoffmann-La Roche

    Switzerland
    ISPE Annual Meeting
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    Regulatory Info : Prescription

    Registration Country : Canada

    COBIMETINIB (COBIMETINIB FUMARATE)

    Brand Name : COTELLIC

    Dosage Form : TABLET

    Dosage Strength : 20MG

    Packaging : 63

    Approval Date :

    Application Number : 2452340

    Regulatory Info : Prescription

    Registration Country : Canada

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    06

    F. Hoffmann-La Roche

    Switzerland
    ISPE Annual Meeting
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    Regulatory Info : Originator

    Registration Country : South Africa

    Cobimetinib

    Brand Name : Cotellic

    Dosage Form : Tabs

    Dosage Strength : 20mg

    Packaging : 63X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    07

    F. Hoffmann-La Roche

    Switzerland
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    Regulatory Info :

    Registration Country : Australia

    Cobimetinib

    Brand Name : Cotellic

    Dosage Form :

    Dosage Strength :

    Packaging : 63

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    08

    F. Hoffmann-La Roche

    Switzerland
    ISPE Annual Meeting
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    Switzerland
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    Regulatory Info :

    Registration Country : Australia

    Cobimetinib

    Brand Name : Cotellic

    Dosage Form :

    Dosage Strength :

    Packaging : 63

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    09

    Genentech

    U.S.A
    ISPE Annual Meeting
    Not Confirmed
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    Genentech

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    COBIMETINIB FUMARATE

    Brand Name : COTELLIC

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 20MG BASE

    Packaging :

    Approval Date : 2015-11-10

    Application Number : 206192

    Regulatory Info : RX

    Registration Country : USA

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    10

    Roche Diagnostics GmbH

    Germany
    ISPE Annual Meeting
    Not Confirmed
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    Roche Diagnostics GmbH

    Germany
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    Not Confirmed
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    Regulatory Info : Authorized

    Registration Country : Spain

    Cobimetinib

    Brand Name : Cotellic

    Dosage Form : Film Coated Tablet

    Dosage Strength : 20MG

    Packaging :

    Approval Date : 2015-12-16

    Application Number : 1151048001

    Regulatory Info : Authorized

    Registration Country : Spain

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