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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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    Nivolumab

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    Regulatory Info :

    Registration Country : USA

    NIVOLUMAB

    Brand Name : OPDIVO

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 40MG/4ML

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    Approval Date :

    Application Number : 125527

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    Registration Country : USA

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    NIVOLUMAB

    Brand Name : OPDIVO

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 100MG/10ML

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    Application Number : 125527

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    NIVOLUMAB

    Brand Name : OPDIVO

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 40MG/4ML

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    Approval Date :

    Application Number : 125554

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    Registration Country : USA

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    NIVOLUMAB;RELATLIMAB-RMBW

    Brand Name : OPDUALAG

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 240MG;80MG

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    Application Number : 761234

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    NIVOLUMAB;HYALURONIDASE-NVHY

    Brand Name : OPDIVO QVANTIG

    Dosage Form : INJECTABLE;SUBCUTANEOUS

    Dosage Strength : 600MG;10000UNITS PER5ML(120MG/2000UNITS PER ML)

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    Approval Date :

    Application Number : 761381

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    Registration Country : USA

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    NIVOLUMAB;HYALURONIDASE-NVHY

    Brand Name : OPDIVO QVANTIG

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 600MG;10000 UNITS PER 5ML(120MG/2000UNITS PER ML)

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    Approval Date :

    Application Number : 761429

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    Registration Country : USA

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    Regulatory Info : Approved

    Registration Country : Sweden

    Nivolumab; Relatlimab (Combination drug known as Opdualag)

    Brand Name : Opdualag

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 240mg;80mg

    Packaging :

    Approval Date : 15/09/2022

    Application Number : 20210913000057

    Regulatory Info : Approved

    Registration Country : Sweden

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    Regulatory Info : Approved

    Registration Country : Sweden

    Nivolumab

    Brand Name : Opdivo

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 10mg/ml

    Packaging :

    Approval Date : 19/06/2015

    Application Number : 20141009000029

    Regulatory Info : Approved

    Registration Country : Sweden

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    Regulatory Info : Approved

    Registration Country : Sweden

    Nivolumab

    Brand Name : Opdivo

    Dosage Form : Injectable Solution

    Dosage Strength : 600mg

    Packaging :

    Approval Date : 26/05/2025

    Application Number : 20240607000049

    Regulatory Info : Approved

    Registration Country : Sweden

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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Nivolumab

    Brand Name : Nivolumab Bms

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 10mg/ml

    Packaging :

    Approval Date : 20/07/2015

    Application Number : 20141009000036

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Nivolumab

    Brand Name : Opdivo

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 40mg/4ml

    Packaging :

    Approval Date : 30/11/2015

    Application Number : 65660

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Nivolumab

    Brand Name : Opdivo

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 100mg/10ml

    Packaging :

    Approval Date : 30/11/2015

    Application Number : 65660

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Nivolumab

    Brand Name : Opdivo

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 240mg/24ml

    Packaging :

    Approval Date : 30/11/2015

    Application Number : 65660

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Regulatory Info : Allowed

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    Nivolumab

    Brand Name : Opdivo

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 120mg/12ml

    Packaging :

    Approval Date : 30/11/2015

    Application Number : 65660

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    Regulatory Info : Prescription

    Registration Country : Canada

    NIVOLUMAB

    Brand Name : OPDIVO

    Dosage Form : SOLUTION

    Dosage Strength : 10MG/ML

    Packaging : 4ML

    Approval Date :

    Application Number : 2446626

    Regulatory Info : Prescription

    Registration Country : Canada

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    Regulatory Info : Prescription

    Registration Country : Canada

    NIVOLUMAB

    Brand Name : OPDIVO

    Dosage Form : SOLUTION

    Dosage Strength : 10MG/ML

    Packaging : 10ML

    Approval Date :

    Application Number : 2446634

    Regulatory Info : Prescription

    Registration Country : Canada

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    Regulatory Info : Prescription

    Registration Country : Canada

    NIVOLUMAB

    Brand Name : OPDUALAG

    Dosage Form : SOLUTION

    Dosage Strength : 240MG/20ML

    Packaging :

    Approval Date :

    Application Number : 2541416

    Regulatory Info : Prescription

    Registration Country : Canada

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    Regulatory Info :

    Registration Country : Australia

    Nivolumab

    Brand Name : Opdivo

    Dosage Form :

    Dosage Strength :

    Packaging : 1

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    Regulatory Info :

    Registration Country : Australia

    Nivolumab

    Brand Name : Opdivo

    Dosage Form :

    Dosage Strength :

    Packaging : 1

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    Regulatory Info :

    Registration Country : Australia

    Nivolumab

    Brand Name : Opdivo

    Dosage Form :

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    Packaging : 1

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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