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    AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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    European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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    Daratumumab

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    Abacus Medicine A/S

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    Abacus Medicine A/S

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    Regulatory Info : Marketed

    Registration Country : Norway

    Daratumumab

    Brand Name : Darzalex

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 20mg/ml

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    Abacus Medicine A/S

    Denmark
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    Regulatory Info : Marketed

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    Daratumumab

    Brand Name : Darzalex

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 20mg/ml

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    Regulatory Info : Marketed

    Registration Country : Norway

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    Janssen-Cilag Ag

    Italy
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Daratumumabum

    Brand Name : Darzalex

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 100mg/5ml

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    Approval Date : 06/12/2016

    Application Number : 66072

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    Registration Country : Switzerland

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    Janssen-Cilag Ag

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    Regulatory Info : Allowed

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    Daratumumabum

    Brand Name : Darzalex

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 400mg/20ml

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    Approval Date : 06/12/2016

    Application Number : 66072

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    Registration Country : Switzerland

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    Janssen-Cilag Ag

    Italy
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    Regulatory Info : Allowed

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    Daratumumabum

    Brand Name : DARZALEX SC

    Dosage Form : Solution For Injection

    Dosage Strength : 1800mg/15ml

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    Approval Date : 13/08/2020

    Application Number : 67689

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Janssen - Cilag International

    Italy
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    Regulatory Info : Prescription

    Registration Country : Estonia

    Daratumumab

    Brand Name : Darzalex

    Dosage Form : Solution For Injection

    Dosage Strength : 1800mg/15ml

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    Regulatory Info : Prescription

    Registration Country : Estonia

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    07

    Janssen - Cilag International

    Italy
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    International Sweetener Colloquium
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    Regulatory Info : Prescription

    Registration Country : Estonia

    Daratumumab

    Brand Name : Darzalex

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 20mg/ml; 20mg/ml

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    Regulatory Info : Prescription

    Registration Country : Estonia

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    08

    Janssen - Cilag International

    Italy
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    Italy
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    International Sweetener Colloquium
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    Regulatory Info : Prescription

    Registration Country : Estonia

    Daratumumab

    Brand Name : Darzalex

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 20mg/ml

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Prescription

    Registration Country : Estonia

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    09

    Janssen-Cilag International N.V.

    Italy
    International Sweetener Colloquium
    Not Confirmed
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    Janssen-Cilag International N.V.

    Italy
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    International Sweetener Colloquium
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    Regulatory Info : Authorized

    Registration Country : Spain

    Daratumumab

    Brand Name : Darzalex

    Dosage Form : Concentrate For Infusion Solution

    Dosage Strength : 20MG

    Packaging :

    Approval Date : 24-09-2019

    Application Number : 1161101002IP

    Regulatory Info : Authorized

    Registration Country : Spain

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    10

    Janssen-Cilag International N.V.

    Italy
    International Sweetener Colloquium
    Not Confirmed
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    Janssen-Cilag International N.V.

    Italy
    arrow
    International Sweetener Colloquium
    Not Confirmed
    • fda
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    Regulatory Info : Authorized

    Registration Country : Spain

    Daratumumab

    Brand Name : Darzalex

    Dosage Form : Injectable Solution

    Dosage Strength : 1800MG

    Packaging :

    Approval Date : 15-06-2020

    Application Number : 1161101004

    Regulatory Info : Authorized

    Registration Country : Spain

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