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01 1EUROCEPT INTERNATIONAL BV

02 1Eurocept International B.V.

03 2Eurocept International Bv

04 2ORPHAN EUROPE SARL

05 2RECORDATI RARE DISEASES SARL

06 1Recordati Ag

07 5Recordati Rare Diseases

08 1Tillomed Spain Laboratories Slu

09 2WAYMADE BV

10 2Waymade Bv

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PharmaCompass

01

ICMD China
Not Confirmed
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ICMD China
Not Confirmed

Carglumic acid

Brand Name : UCEDANE

Dosage Form : Dispersible Tablet Oral Use Blister

Dosage Strength : 200 mg

Packaging : 60 UNITS 200 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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02

ICMD China
Not Confirmed
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ICMD China
Not Confirmed

Carglumic acid

Brand Name : Ucedane

Dosage Form : Dispersible Tablet

Dosage Strength : 200mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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03

ICMD China
Not Confirmed
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ICMD China
Not Confirmed

Carglumic Acid

Brand Name : Ucedane

Dosage Form : Dispersible Tablet

Dosage Strength : 200mg

Packaging :

Approval Date : 23-06-2017

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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04

ICMD China
Not Confirmed
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ICMD China
Not Confirmed

N-Carbamylglutamate

Brand Name : Carbaglu

Dosage Form : Carglumic Acid 200Mg 60 Units Oral Use

Dosage Strength : 60 cpr dispers 200 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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05

ICMD China
Not Confirmed
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ICMD China
Not Confirmed

N-Carbamylglutamate

Brand Name : Carbaglu

Dosage Form : Carglumic Acid 200Mg 5 Units' Oral Use

Dosage Strength : 5 cpr dispers 200 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

ICMD China
Not Confirmed
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ICMD China
Not Confirmed

Acidum Carglumicum

Brand Name : Carbaglu

Dosage Form : Tablet For Oral Suspension

Dosage Strength : 200mg

Packaging :

Approval Date : 2020-07-28

Application Number : 67376

Regulatory Info : Allowed

Registration Country : Switzerland

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07

ICMD China
Not Confirmed
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ICMD China
Not Confirmed

Carglumic acid

Brand Name : Carbaglu

Dosage Form : Dispersible Tablet

Dosage Strength : 200mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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08

ICMD China
Not Confirmed
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ICMD China
Not Confirmed

Carglumic Acid

Brand Name : Carbaglu

Dosage Form : Dispersible Tablet

Dosage Strength : 200MG

Packaging :

Approval Date : 28-10-2003

Application Number : 2246001

Regulatory Info : Authorized

Registration Country : Spain

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09

ICMD China
Not Confirmed
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ICMD China
Not Confirmed

Carglumic Acid

Brand Name : Carbaglu

Dosage Form : Dispersible Tablet

Dosage Strength : 200MG

Packaging :

Approval Date : 28-10-2003

Application Number : 2246002

Regulatory Info : Authorized

Registration Country : Spain

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10

Eurocept International Bv

Country
ICMD China
Not Confirmed
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Eurocept International Bv

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ICMD China
Not Confirmed

Carglumic Acid

Brand Name : Cured

Dosage Form : Dispersible Tablet

Dosage Strength : 200MG

Packaging :

Approval Date : 07-03-2018

Application Number : 1171202001

Regulatory Info : Authorized

Registration Country : Spain

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