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    01 1AS Kalceks

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    03 1Aristo Pharma Gmbh

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    Aristo Pharma Gmbh

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    Regulatory Info : Approved

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    Sodium Oxibate

    Brand Name : Arixobate

    Dosage Form : Oral Solution

    Dosage Strength : 500mg/ml

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    Approval Date : 12/11/2020

    Application Number : 20190614000016

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    Sodium Oxybate

    Brand Name : Natrii oxybutyras

    Dosage Form : Solution for Injection

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    Regulatory Info : Approved

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    Sodium Oxibate

    Brand Name : Natriumoxibat Kalceks

    Dosage Form : Oral Solution

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    Approval Date : 23/09/2019

    Application Number : 20180928000062

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    Sodium Oxibate

    Brand Name : Natriumoxibat Reig Jofre

    Dosage Form : Oral Solution

    Dosage Strength : 500mg/ml

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    Approval Date : 12/09/2019

    Application Number : 20171127000038

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    Sodium Oxibate

    Brand Name : Sodium Oxibate Normon

    Dosage Form : Oral Solution

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    Approval Date : 2019-08-13

    Application Number : 84433

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    Ucb Pharma Sa

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    Regulatory Info : Approved

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    Sodium Oxibate

    Brand Name : Xyrem

    Dosage Form : Oral Solution

    Dosage Strength : 500mg/ml

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    Approval Date : 13/10/2005

    Application Number : 20040607004715

    Regulatory Info : Approved

    Registration Country : Sweden

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Sodium Oxybase

    Brand Name : Xyrem

    Dosage Form : Oral Solution

    Dosage Strength : 500mg

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    Approval Date : 09/06/2006

    Application Number : 57184

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Registration Country : Italy

    Sodium Oxybate

    Brand Name : Alcover

    Dosage Form : Sodium Oxybate 17.5% 10Ml 12 Combined Oral Use

    Dosage Strength : os soluz 12 vials 10 ml 17.5%

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    Registration Country : Italy

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    Registration Country : Italy

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    Brand Name : Alcover

    Dosage Form : Sodium Oxybate 17.5% 140Ml Oral Use

    Dosage Strength : os soluz 140 ml 17.5%

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    Registration Country : Italy

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    Ascend Gmbh

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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Sodium Oxibate

    Brand Name : Sodium Oxybate Ascend

    Dosage Form : Oral Solution

    Dosage Strength : 500mg/ml

    Packaging :

    Approval Date : 13/08/2019

    Application Number : 20170801000081

    Regulatory Info : Deregistered

    Registration Country : Sweden

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