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01 1AS Kalceks

02 1Accord Healthcare Slu

03 1Aristo Pharma Gmbh

04 1As Kalceks

05 1Ascend Gmbh

06 2C.T. LAB.FARMACEUTICO Srl

07 1Farmak JSC

08 8Farmak Sa

09 2Kalceks As

10 1Laboratorio Reig Jofre Sa

11 1Normon Laboratories Sa

12 1Reig Jofre Laboratory, Sa

13 1UCB Pharma SA (2)

14 2Ucb Pharma

15 1Ucb Pharma Sa

16 1Ucb-Pharma Sa

17 1Zentiva Ks

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PharmaCompass

01

Asia Pharma Expo
Not Confirmed
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Asia Pharma Expo
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Sodium Oxibate

Brand Name : Anartex

Dosage Form : Oral Solution

Dosage Strength : 300MG

Packaging :

Approval Date : 11-10-2017

Application Number : 82521

Regulatory Info : Authorized

Registration Country : Spain

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02

Asia Pharma Expo
Not Confirmed
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Asia Pharma Expo
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Sodium Oxibate

Brand Name : Arixobate

Dosage Form : Oral Solution

Dosage Strength : 500mg/ml

Packaging :

Approval Date : 12/11/2020

Application Number : 20190614000016

Regulatory Info : Approved

Registration Country : Sweden

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03

Asia Pharma Expo
Not Confirmed
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Asia Pharma Expo
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Sodium Oxybate

Brand Name : Natrii oxybutyras

Dosage Form : Solution for Injection

Dosage Strength : 200MG/ML

Packaging : 5ML, 10ML

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Ukraine

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04

Asia Pharma Expo
Not Confirmed
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Asia Pharma Expo
Not Confirmed

Sodium oxybutyrate

Brand Name : Oxibutirat de sodiu

Dosage Form : Injectable Solution

Dosage Strength : 200mg/ml

Packaging :

Approval Date : 04-04-2019

Application Number :

Regulatory Info :

Registration Country : Moldova

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05

Asia Pharma Expo
Not Confirmed
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Asia Pharma Expo
Not Confirmed

Sodium oxybutyrate

Brand Name : Oxibutirat de sodiu

Dosage Form : Injectable Solution

Dosage Strength : 200mg/ml

Packaging :

Approval Date : 04-04-2019

Application Number :

Regulatory Info :

Registration Country : Moldova

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06

Asia Pharma Expo
Not Confirmed
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Asia Pharma Expo
Not Confirmed

Sodium Oxibate

Brand Name : Natriumoxibat Kalceks

Dosage Form : Oral Solution

Dosage Strength : 500mg/ml

Packaging :

Approval Date : 23/09/2019

Application Number : 20180928000062

Regulatory Info : Approved

Registration Country : Sweden

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07

Asia Pharma Expo
Not Confirmed
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Asia Pharma Expo
Not Confirmed

Sodium oxybate

Brand Name : Sodium oxybate Kalceks

Dosage Form : Syrup

Dosage Strength : 500mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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08

C.T. LAB.FARMACEUTICO Srl

Country
Asia Pharma Expo
Not Confirmed
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C.T. LAB.FARMACEUTICO Srl

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Asia Pharma Expo
Not Confirmed

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%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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09

C.T. LAB.FARMACEUTICO Srl

Country
Asia Pharma Expo
Not Confirmed
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C.T. LAB.FARMACEUTICO Srl

Country
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Asia Pharma Expo
Not Confirmed

Sodium Oxybate

Brand Name : Alcover

Dosage Form : Sodium Oxybate 17.5% 140Ml Oral Use

Dosage Strength : os soluz 140 ml 17.5%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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10

Ascend Gmbh

Country
Asia Pharma Expo
Not Confirmed
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Ascend Gmbh

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Asia Pharma Expo
Not Confirmed

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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