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01 1EUROCEPT INTERNATIONAL BV

02 2Eurocept International Bv

03 2ORPHAN EUROPE SARL

04 3Orphan Europe SARL

05 2RECORDATI RARE DISEASES SARL

06 1Recordati Ag

07 4Recordati Rare Diseases

08 1Tillomed Spain Laboratories Slu

09 2WAYMADE BV

10 2Waymade Bv

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PharmaCompass

01

FNCE
Not Confirmed
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FNCE
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

FNCE
Not Confirmed
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FNCE
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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03

FNCE
Not Confirmed
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FNCE
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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04

FNCE
Not Confirmed
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FNCE
Not Confirmed

N-Carbamylglutamate

Brand Name : Carbaglu

Dosage Form : Dispergerbar Antic-Calc tablet

Dosage Strength : 200 mg

Packaging : Box

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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05

FNCE
Not Confirmed
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FNCE
Not Confirmed

N-Carbamylglutamate

Brand Name : Carbaglu

Dosage Form : Dispergerbar Antic-Calc tablet

Dosage Strength : 200 mg

Packaging : Box

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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06

FNCE
Not Confirmed
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FNCE
Not Confirmed

N-Carbamylglutamate

Brand Name : Carbaglu

Dosage Form : Dispergerbar Antic-Calc tablet

Dosage Strength : 200 mg

Packaging : Box

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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07

FNCE
Not Confirmed
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FNCE
Not Confirmed

Carglumic acid

Brand Name : CARBAGLU

Dosage Form : Dispersible Tablet

Dosage Strength : 200 mg

Packaging : 5 UNITS 200 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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08

FNCE
Not Confirmed
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FNCE
Not Confirmed

Carglumic acid

Brand Name : CARBAGLU

Dosage Form : Dispersible Tablet

Dosage Strength : 200 mg

Packaging : 60 UNITS 200 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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09

FNCE
Not Confirmed
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FNCE
Not Confirmed

Carglumic acid

Brand Name : WAYMADE CARGLUMIC ACID

Dosage Form : Dispersible Tablets

Dosage Strength : 200 mg

Packaging : 5 UNITS 200 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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10

FNCE
Not Confirmed
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FNCE
Not Confirmed

Carglumic acid

Brand Name : WAYMADE CARGLUMIC ACID*

Dosage Form : Dispersible Tablets

Dosage Strength : 200 mg

Packaging : 60 UNITS 200 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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