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    Gamma Hydroxybutyric Acid Sodium

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    01 1Accord Healthcare Slu

    02 1Aristo Pharma Gmbh

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    04 1Ascend Gmbh

    05 2C.T. LAB.FARMACEUTICO Srl

    06 1Farmak JSC

    07 1Grindeks AS

    08 1Kalceks As

    09 1Laboratorio Reig Jofre Sa

    10 1Normon Laboratories Sa

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    Aristo Pharma Gmbh

    Germany
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    Regulatory Info : Approved

    Registration Country : Sweden

    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

    Regulatory Info : Approved

    Registration Country : Sweden

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    Farmak JSC

    Ukraine
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    Sodium Oxybate

    Brand Name : Natrii oxybutyras

    Dosage Form : Solution for Injection

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    Grindeks AS

    Latvia
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    Dosage Form : INJECTION

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    As Kalceks

    Latvia
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    Regulatory Info : Approved

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    Sodium Oxibate

    Brand Name : Natriumoxibat Kalceks

    Dosage Form : Oral Solution

    Dosage Strength : 500mg/ml

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    Approval Date : 23/09/2019

    Application Number : 20180928000062

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    Registration Country : Sweden

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    Laboratorio Reig Jofre Sa

    Spain
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    Regulatory Info : Approved

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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

    Regulatory Info : Approved

    Registration Country : Sweden

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    06

    Ucb Pharma Sa

    Belgium
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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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    07

    Ucb-Pharma Sa

    Belgium
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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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    08

    C.T. LAB.FARMACEUTICO Srl

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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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    09

    C.T. LAB.FARMACEUTICO Srl

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    Registration Country : Italy

    Sodium Oxybate

    Brand Name : Alcover

    Dosage Form : Sodium Oxybate 17.5% 140Ml Oral Use

    Dosage Strength : os soluz 140 ml 17.5%

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    Approval Date :

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    Regulatory Info :

    Registration Country : Italy

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    Ascend Gmbh

    Country
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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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