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    Sodium Phenylbutyrate

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    01 4Eurocept International Bv

    02 4Immedica Pharma Ab

    03 1LUCANE PHARMA SA

    04 1Lucane Pharma

    05 1Medius Ag

    06 2SWEDISH ORPHAN BIOVITR.INT.AB

    07 2Swedish Orphan International AB

    08 1Tobio Novelfarma

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    01

    Eurocept International Bv

    Netherlands
    FNCE
    Not Confirmed
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    Eurocept International Bv

    Netherlands
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    Regulatory Info : Approved

    Registration Country : Sweden

    Sodium Phenylbutyrate

    Brand Name : Pheburane

    Dosage Form : Oral Solution

    Dosage Strength : 350mg/ml

    Packaging :

    Approval Date : 23/11/2023

    Application Number : 20230109000012

    Regulatory Info : Approved

    Registration Country : Sweden

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    02

    Immedica Pharma Ab

    Sweden
    FNCE
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    Immedica Pharma Ab

    Sweden
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    Regulatory Info : Approved

    Registration Country : Sweden

    Sodium Phenylbutyrate

    Brand Name : Ammonaps

    Dosage Form : Tablet

    Dosage Strength : 500mg

    Packaging :

    Approval Date : 08/12/1999

    Application Number : 19991208000023

    Regulatory Info : Approved

    Registration Country : Sweden

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    03

    Immedica Pharma Ab

    Sweden
    FNCE
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    Immedica Pharma Ab

    Sweden
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    FNCE
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    Regulatory Info : Approved

    Registration Country : Sweden

    Sodium Phenylbutyrate

    Brand Name : Ammonaps

    Dosage Form : Granules

    Dosage Strength : 940mg/g

    Packaging :

    Approval Date : 08/12/1999

    Application Number : 19991208000016

    Regulatory Info : Approved

    Registration Country : Sweden

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    04

    SWEDISH ORPHAN BIOVITR.INT.AB

    Sweden
    FNCE
    Not Confirmed
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    SWEDISH ORPHAN BIOVITR.INT.AB

    Sweden
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    Regulatory Info :

    Registration Country : Italy

    Sodium 4-Phenylbutyrate

    Brand Name : Ammonaps

    Dosage Form : Sodium Phenylbutyrate 500Mg 250 Unita' Oral Use

    Dosage Strength : 250 CPR 500 mg bottle

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    05

    SWEDISH ORPHAN BIOVITR.INT.AB

    Sweden
    FNCE
    Not Confirmed
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    SWEDISH ORPHAN BIOVITR.INT.AB

    Sweden
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    Regulatory Info :

    Registration Country : Italy

    Sodium 4-Phenylbutyrate

    Brand Name : Ammonaps

    Dosage Form : Sodium Phenylbutyrate 266G 940Mg/G Oral Use

    Dosage Strength : os granulate for suspension 266 g 940 mg/g

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    06

    Swedish Orphan International AB

    Sweden
    FNCE
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    Swedish Orphan International AB

    Sweden
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    FNCE
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    Regulatory Info :

    Registration Country : Norway

    Sodium 4-Phenylbutyrate

    Brand Name : Ammonaps

    Dosage Form : Antic-calc Tablet

    Dosage Strength : 500 mg

    Packaging : Bottle

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    07

    Swedish Orphan International AB

    Sweden
    FNCE
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    Swedish Orphan International AB

    Sweden
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    FNCE
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    Regulatory Info :

    Registration Country : Norway

    Sodium 4-Phenylbutyrate

    Brand Name : Ammonaps

    Dosage Form : Granules

    Dosage Strength : 940 mg/g

    Packaging : Bottle

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    08

    Tobio Novelfarma

    Turkey
    FNCE
    Not Confirmed
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    Tobio Novelfarma

    Turkey
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    FNCE
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    Regulatory Info : Lic. No- 24.12.2020/2020-272

    Registration Country : Turkey

    Sodium Phenylbutyrate

    Brand Name : HIPER-AMONEMIX

    Dosage Form : Granules

    Dosage Strength : 940MG/1G

    Packaging : 266 g/ Bottle

    Approval Date :

    Application Number :

    Regulatory Info : Lic. No- 24.12.2020/2020-272

    Registration Country : Turkey

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    09

    LUCANE PHARMA SA

    Country
    FNCE
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    LUCANE PHARMA SA

    Country
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    FNCE
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    Regulatory Info :

    Registration Country : Italy

    Sodium 4-Phenylbutyrate

    Brand Name : Pheburane

    Dosage Form : Sodium Phenylbutyrate 174G 483Mg/G Oral Use

    Dosage Strength : os grat suspe 174 g 483 mg/g

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    10

    Lucane Pharma

    Country
    FNCE
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    Lucane Pharma

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    FNCE
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    Regulatory Info :

    Registration Country : Norway

    Sodium 4-Phenylbutyrate

    Brand Name : Pheburane

    Dosage Form : Granules

    Dosage Strength : 483 mg/g

    Packaging : Bottle

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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