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    Trastuzumab

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    07 2BIOSIMILAR COLLABORATIONS IRELAND LIMITED

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    01

    Accord BioPharma

    U.S.A
    CTAD25
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    Accord BioPharma

    U.S.A
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    Registration Country : USA

    TRASTUZUMAB-STRF

    Brand Name : HERCESSI

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 150MG

    Packaging :

    Approval Date :

    Application Number : 761346

    Regulatory Info :

    Registration Country : USA

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    02

    Amgen Inc

    U.S.A
    CTAD25
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    Amgen Inc

    U.S.A
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    TRASTUZUMAB-ANNS

    Brand Name : KANJINTI

    Dosage Form : VIAL; MULTIDOSE

    Dosage Strength : 420MG

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    Application Number : 761073

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    Registration Country : USA

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    03

    Amgen Inc

    U.S.A
    CTAD25
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    U.S.A
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    CTAD25
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    TRASTUZUMAB-ANNS

    Brand Name : KANJINTI

    Dosage Form : VIAL;SINGLE-DOSE

    Dosage Strength : 150MG

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    Application Number : 761073

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    Registration Country : USA

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    04

    Aprogen

    South Korea
    CTAD25
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    Aprogen

    South Korea
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    Trastuzumab

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    05

    Celltrion

    South Korea
    CTAD25
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    Celltrion

    South Korea
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    TRASTUZUMAB-PKRB

    Brand Name : HERZUMA

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 420MG

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    Application Number : 761091

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    Registration Country : USA

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    06

    CinnaGen

    Iran
    CTAD25
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    CinnaGen

    Iran
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    Registration Country : Iran

    Trastuzumab

    Brand Name : AryoTrust

    Dosage Form : Injectable

    Dosage Strength : 150MG

    Packaging : Vial

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    Regulatory Info :

    Registration Country : Iran

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    07

    CinnaGen

    Iran
    CTAD25
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    CinnaGen

    Iran
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    CTAD25
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    Trastuzumab

    Brand Name : AryoTrust

    Dosage Form : Injectable

    Dosage Strength : 440MG

    Packaging : Vial

    Approval Date :

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    Registration Country : Iran

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    08

    F. Hoffmann-La Roche

    Switzerland
    CTAD25
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    Registration Country : Italy

    Trastuzumab

    Brand Name : Herceptin

    Dosage Form : Trastuzumab 150Mg 1 Unit Parenteral Use

    Dosage Strength : 1 vial groun EV 150 mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    09

    F. Hoffmann-La Roche

    Switzerland
    CTAD25
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    F. Hoffmann-La Roche

    Switzerland
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    Regulatory Info :

    Registration Country : Italy

    Trastuzumab

    Brand Name : Herceptin

    Dosage Form : Trastuzumab 600Mg 1 Unit Parenteral Use

    Dosage Strength : 1 vial SC 600 mg/5 ml 6 ml

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    10

    F. Hoffmann-La Roche

    Switzerland
    CTAD25
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    F. Hoffmann-La Roche

    Switzerland
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    CTAD25
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    Regulatory Info : Approved

    Registration Country : Sweden

    Pertuzumab; Trastuzumab

    Brand Name : Phesgo

    Dosage Form : Injectable Solution

    Dosage Strength : 1200mg;600mg

    Packaging :

    Approval Date : 21/12/2020

    Application Number : 20200111000010

    Regulatory Info : Approved

    Registration Country : Sweden

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    11

    F. Hoffmann-La Roche

    Switzerland
    CTAD25
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    F. Hoffmann-La Roche

    Switzerland
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    CTAD25
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Pertuzumabum; Trastuzumabum

    Brand Name : Phesgo mg

    Dosage Form : Solution For Injection

    Dosage Strength : 600mg/10ml;600mg/10ml

    Packaging :

    Approval Date : 08/04/2021

    Application Number : 67828

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    12

    F. Hoffmann-La Roche

    Switzerland
    CTAD25
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    Switzerland
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    CTAD25
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Pertuzumabum; Trastuzumabum

    Brand Name : Phesgo mg

    Dosage Form : Solution For Injection

    Dosage Strength : 1200mg/15ml;600mg/15ml

    Packaging :

    Approval Date : 08/04/2021

    Application Number : 67828

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    13

    F. Hoffmann-La Roche

    Switzerland
    CTAD25
    Not Confirmed
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    F. Hoffmann-La Roche

    Switzerland
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    CTAD25
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    Regulatory Info : Approved

    Registration Country : Sweden

    Pertuzumab; Trastuzumab

    Brand Name : Phesgo

    Dosage Form : Injectable Solution

    Dosage Strength : 600mg/ml;600mg/ml

    Packaging :

    Approval Date : 21/12/2020

    Application Number : 20200111000027

    Regulatory Info : Approved

    Registration Country : Sweden

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    14

    Genentech

    U.S.A
    CTAD25
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    U.S.A
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    Regulatory Info :

    Registration Country : USA

    TRASTUZUMAB

    Brand Name : HERCEPTIN

    Dosage Form : VIAL; INTRAVENOUS

    Dosage Strength : 21MG/ML

    Packaging :

    Approval Date :

    Application Number : 103792

    Regulatory Info :

    Registration Country : USA

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    15

    Genentech

    U.S.A
    CTAD25
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    CTAD25
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    Registration Country : USA

    PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXF

    Brand Name : PHESGO

    Dosage Form : INJECTABLE;SUBCUTANEOUS

    Dosage Strength : 1,200MG;600MG;30,000UNITS

    Packaging :

    Approval Date :

    Application Number : 761170

    Regulatory Info :

    Registration Country : USA

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    16

    Genentech

    U.S.A
    CTAD25
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    PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXF

    Brand Name : PHESGO

    Dosage Form : INJECTABLE;SUBCUTANEOUS

    Dosage Strength : 600MG;600MG;20,000UNITS

    Packaging :

    Approval Date :

    Application Number : 761170

    Regulatory Info :

    Registration Country : USA

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    17

    Pfizer Inc

    U.S.A
    CTAD25
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    Pfizer Inc

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    Registration Country : USA

    TRASTUZUMAB-QYYP

    Brand Name : TRAZIMERA

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 420MG

    Packaging :

    Approval Date :

    Application Number : 761081

    Regulatory Info :

    Registration Country : USA

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    18

    Samsung Bioepis

    South Korea
    CTAD25
    Not Confirmed
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    Samsung Bioepis

    South Korea
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    CTAD25
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    Registration Country : USA

    TRASTUZUMAB-DTTB

    Brand Name : ONTRUZANT

    Dosage Form : POWDER;IV (INFUSION)

    Dosage Strength : 150MG

    Packaging :

    Approval Date :

    Application Number : 761100

    Regulatory Info :

    Registration Country : USA

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    19

    Samsung Bioepis

    South Korea
    CTAD25
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    South Korea
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    CTAD25
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    Regulatory Info :

    Registration Country : USA

    TRASTUZUMAB-DTTB

    Brand Name : ONTRUZANT

    Dosage Form : POWDER;IV (INFUSION)

    Dosage Strength : 420MG

    Packaging :

    Approval Date :

    Application Number : 761100

    Regulatory Info :

    Registration Country : USA

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    20

    Viatris

    U.S.A
    CTAD25
    Not Confirmed
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    Viatris

    U.S.A
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    CTAD25
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    Registration Country : USA

    TRASTUZUMAB-DKST

    Brand Name : OGIVRI

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 420MG/VIAL

    Packaging :

    Approval Date :

    Application Number : 761074

    Regulatory Info :

    Registration Country : USA

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