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01 1Eurocept International BV

02 4Eurocept International Bv

03 2Immedica Pharma AB (1)

04 4Immedica Pharma Ab

05 1LUCANE PHARMA SA

06 1Medius Ag

07 2SWEDISH ORPHAN BIOVITR.INT.AB

08 1Tobio Novelfarma

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PharmaCompass

01

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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

VMX
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VMX
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Sodium Phenylbutyrate

Brand Name : Pheburane

Dosage Form : Granules

Dosage Strength : 483mg/g

Packaging :

Approval Date : 31/07/2013

Application Number : 20120413000016

Regulatory Info : Approved

Registration Country : Sweden

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03

VMX
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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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04

VMX
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VMX
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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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05

VMX
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VMX
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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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06

VMX
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VMX
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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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07

VMX
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VMX
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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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08

LUCANE PHARMA SA

Country
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LUCANE PHARMA SA

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VMX
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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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09

Medius Ag

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VMX
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Medius Ag

Country
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VMX
Not Confirmed

Sodium Phenylbutyrate

Brand Name : Pheburane g

Dosage Form : Granule For Oral Solution

Dosage Strength : 483mg

Packaging :

Approval Date : 29/07/2020

Application Number : 67263

Regulatory Info : Allowed

Registration Country : Switzerland

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10

Eurocept International Bv

Country
VMX
Not Confirmed
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Eurocept International Bv

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VMX
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Sodium Phenylbutyrate

Brand Name : Pheburane

Dosage Form : Granule

Dosage Strength : 483MG

Packaging :

Approval Date : 2014-03-05

Application Number : 113822001

Regulatory Info : Authorized

Registration Country : Spain

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