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    Trastuzumab Emtansine

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    01

    F. Hoffmann-La Roche

    Switzerland
    Aus. Peptide Conference
    Not Confirmed
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    Regulatory Info : Approved

    Registration Country : Sweden

    Trastuzumab Emtansine

    Brand Name : Kadcyla

    Dosage Form : Powder For Concentrate For Solution For Infusion

    Dosage Strength : 100mg

    Packaging :

    Approval Date : 15/11/2013

    Application Number : 20121010000058

    Regulatory Info : Approved

    Registration Country : Sweden

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    02

    F. Hoffmann-La Roche

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    Regulatory Info : Approved

    Registration Country : Sweden

    Trastuzumab Emtansine

    Brand Name : Kadcyla

    Dosage Form : Powder For Concentrate For Solution For Infusion

    Dosage Strength : 160mg

    Packaging :

    Approval Date : 15/11/2013

    Application Number : 20121010000065

    Regulatory Info : Approved

    Registration Country : Sweden

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    03

    F. Hoffmann-La Roche

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Trastuzumab Emtansine

    Brand Name : Kadcyla

    Dosage Form : Powder For Concentrate For Solution For Infusion

    Dosage Strength : 100mg

    Packaging :

    Approval Date : 02/05/2013

    Application Number : 62892

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    04

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Trastuzumab Emtansine

    Brand Name : Kadcyla

    Dosage Form : Powder For Concentrate For Solution For Infusion

    Dosage Strength : 160mg

    Packaging :

    Approval Date : 02/05/2013

    Application Number : 62892

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    05

    F. Hoffmann-La Roche

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    Regulatory Info : Prescription

    Registration Country : Canada

    TRASTUZUMAB EMTANSINE

    Brand Name : KADCYLA

    Dosage Form : POWDER FOR SOLUTION

    Dosage Strength : 100MG/VIAL

    Packaging : 15ML/20ML

    Approval Date :

    Application Number : 2412365

    Regulatory Info : Prescription

    Registration Country : Canada

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    06

    F. Hoffmann-La Roche

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    Regulatory Info : Prescription

    Registration Country : Canada

    TRASTUZUMAB EMTANSINE

    Brand Name : KADCYLA

    Dosage Form : POWDER FOR SOLUTION

    Dosage Strength : 160MG/VIAL

    Packaging :

    Approval Date :

    Application Number : 2473224

    Regulatory Info : Prescription

    Registration Country : Canada

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    07

    F. Hoffmann-La Roche

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    Regulatory Info : Originator

    Registration Country : South Africa

    Trastuzumab Emtansine

    Brand Name : Kadcyla 100

    Dosage Form : INF

    Dosage Strength : 100mg

    Packaging : 5X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    08

    F. Hoffmann-La Roche

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    Regulatory Info : Originator

    Registration Country : South Africa

    Trastuzumab Emtansine

    Brand Name : Kadcyla 160

    Dosage Form : INF

    Dosage Strength : 160mg

    Packaging : 8X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    09

    F. Hoffmann-La Roche

    Switzerland
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    Regulatory Info :

    Registration Country : Australia

    Trastuzumab emtansine

    Brand Name : Kadcyla

    Dosage Form :

    Dosage Strength :

    Packaging : 1

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    10

    F. Hoffmann-La Roche

    Switzerland
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    Switzerland
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    Regulatory Info :

    Registration Country : Australia

    Trastuzumab emtansine

    Brand Name : Kadcyla

    Dosage Form :

    Dosage Strength :

    Packaging : 1

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    11

    F. Hoffmann-La Roche

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    Regulatory Info :

    Registration Country : Australia

    Trastuzumab emtansine

    Brand Name : Kadcyla

    Dosage Form :

    Dosage Strength :

    Packaging : 1

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    12

    F. Hoffmann-La Roche

    Switzerland
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    Not Confirmed
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    Switzerland
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    Registration Country : Australia

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    Brand Name : Kadcyla

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    Dosage Strength :

    Packaging : 1

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    13

    F. Hoffmann-La Roche

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    Registration Country : Australia

    Trastuzumab emtansine

    Brand Name : Kadcyla

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    Dosage Strength :

    Packaging : 1

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    14

    F. Hoffmann-La Roche

    Switzerland
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    Registration Country : Australia

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    Packaging : 1

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    15

    F. Hoffmann-La Roche

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    Brand Name : Kadcyla

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    Packaging : 1

    Approval Date :

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    16

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    17

    Roche Diagnostics GmbH

    Germany
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    Regulatory Info : Authorized

    Registration Country : Spain

    Trastuzumab Emtansine

    Brand Name : Kadcyla

    Dosage Form : Powder For Concentrate For Infusion Solution

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 2013-12-26

    Application Number : 113885001

    Regulatory Info : Authorized

    Registration Country : Spain

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    Trastuzumab Emtansine

    Brand Name : Kadcyla

    Dosage Form : Powder For Concentrate For Infusion Solution

    Dosage Strength : 160MG

    Packaging :

    Approval Date : 2020-11-03

    Application Number : 113885002IP

    Regulatory Info : Authorized

    Registration Country : Spain

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    19

    Roche Diagnostics GmbH

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    Trastuzumab Emtansine

    Brand Name : Kadcyla

    Dosage Form : Powder For Concentrate For Infusion Solution

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 2024-05-22

    Application Number : 113885001IP1

    Regulatory Info : Authorized

    Registration Country : Spain

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    Roche Diagnostics GmbH

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    Trastuzumab Emtansine

    Brand Name : Kadcyla

    Dosage Form : Powder For Concentrate For Infusion Solution

    Dosage Strength : 160MG

    Packaging :

    Approval Date : 2024-05-22

    Application Number : 113885002IP1

    Regulatory Info : Authorized

    Registration Country : Spain

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