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    esketamine HCl

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    Eurocept International Bv

    Netherlands
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    Regulatory Info : Approved

    Registration Country : Sweden

    Esketamine Hydrochloride

    Brand Name : Sinmelan

    Dosage Form : Injectable Solution

    Dosage Strength : 25mg/ml

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    Approval Date : 31/07/2018

    Application Number : 20170502000045

    Regulatory Info : Approved

    Registration Country : Sweden

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    Eurocept International Bv

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    Regulatory Info : Approved

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    Esketamine Hydrochloride

    Brand Name : Sinmelan

    Dosage Form : Injectable Solution

    Dosage Strength : 5mg/ml

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    Approval Date : 31/07/2018

    Application Number : 20170502000038

    Regulatory Info : Approved

    Registration Country : Sweden

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Esketamine

    Brand Name : Spravato

    Dosage Form : Nasal Spray Solution

    Dosage Strength : 28mg/spray

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    Approval Date : 25/02/2020

    Application Number : 67103

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Regulatory Info : Approved

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    Esketamine Hydrochloride

    Brand Name : Spravato

    Dosage Form : Inhalation Spray

    Dosage Strength : 28mg

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    Approval Date : 18/12/2019

    Application Number : 20181012000036

    Regulatory Info : Approved

    Registration Country : Sweden

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    Regulatory Info : Prescription

    Registration Country : Estonia

    Esketamine

    Brand Name : Spravato

    Dosage Form : Nasal Spray Solution

    Dosage Strength : 28mg

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    Approval Date :

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    Regulatory Info : Prescription

    Registration Country : Estonia

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    Janssen-Cilag International N.V.

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    Regulatory Info : Authorized

    Registration Country : Spain

    Esketamine Hydrochloride

    Brand Name : Spravato

    Dosage Form : Solution For Nasal Spray

    Dosage Strength : 28MG

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    Approval Date : 05-02-2020

    Application Number : 1191410001

    Regulatory Info : Authorized

    Registration Country : Spain

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    07

    As Kalceks

    Latvia
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    Regulatory Info : Approved

    Registration Country : Sweden

    Esketamine Hydrochloride

    Brand Name : Esketamine Kalceks

    Dosage Form : Solution For Injection/Infusion

    Dosage Strength : 25mg/ml

    Packaging :

    Approval Date : 06/11/2019

    Application Number : 20181129000097

    Regulatory Info : Approved

    Registration Country : Sweden

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    As Kalceks

    Latvia
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    Regulatory Info : Approved

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    Esketamine Hydrochloride

    Brand Name : Esketamine Kalceks

    Dosage Form : Solution For Injection/Infusion

    Dosage Strength : 5mg/ml

    Packaging :

    Approval Date : 06/11/2019

    Application Number : 20181129000080

    Regulatory Info : Approved

    Registration Country : Sweden

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    09

    International Drug Development

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    Regulatory Info : Approved

    Registration Country : Sweden

    Esketamine Hydrochloride

    Brand Name : Esketamine Idd

    Dosage Form : Solution For Injection/Infusion

    Dosage Strength : 25mg/ml

    Packaging :

    Approval Date : 18/01/2019

    Application Number : 20171020000067

    Regulatory Info : Approved

    Registration Country : Sweden

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    10

    International Drug Development

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    International Drug Development

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    ASPEN
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    Regulatory Info : Approved

    Registration Country : Sweden

    Esketamine Hydrochloride

    Brand Name : Esketamine Idd

    Dosage Form : Solution For Injection/Infusion

    Dosage Strength : 5mg/ml

    Packaging :

    Approval Date : 18/01/2019

    Application Number : 20171020000050

    Regulatory Info : Approved

    Registration Country : Sweden

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