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01 1AB ANALITICA Srl

02 1Ferrer Internacional Sa

03 3ITC FARMA Srl

04 2Infai Ch Gmbh

05 2Infai Gmbh

06 1Isomed Pharma Sl

07 2Mayoly Spindler Laboratories

08 1RICHEN CORTEX EUROPE Srl

09 2SOFAR SpA

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PharmaCompass

01

OTS 2025
Not Confirmed
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OTS 2025
Not Confirmed

13-C Urea

Brand Name : Helikit

Dosage Form : Powder For Oral Solution

Dosage Strength : 75MG

Packaging :

Approval Date : 2019-05-21

Application Number : 83391

Regulatory Info : Cancelled

Registration Country : Spain

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02

OTS 2025
Not Confirmed
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OTS 2025
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Urea C13

Brand Name : Expirobacter

Dosage Form : C-13 Urea 100Mg 1 Combined Oral Use

Dosage Strength : 1 CPR 100 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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03

OTS 2025
Not Confirmed
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OTS 2025
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Urea C13

Brand Name : Expirobacter

Dosage Form : C-13 Urea 100Mg 1 Combined Oral Use

Dosage Strength : 1 cpr solub 100 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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04

ITC FARMA Srl

Country
OTS 2025
Not Confirmed
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ITC FARMA Srl

Country
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OTS 2025
Not Confirmed

Urea C13

Brand Name : Helicokit

Dosage Form : C-13 Urea 37.5 Mg 2 Units' Oral Use

Dosage Strength : 2 CPR 37.5 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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05

ITC FARMA Srl

Country
OTS 2025
Not Confirmed
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ITC FARMA Srl

Country
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OTS 2025
Not Confirmed

Urea C13

Brand Name : Helicokit

Dosage Form : C-13 Urea 75Mg 1 Combined Oral Use

Dosage Strength : 1 CPR 75 mg + Kit

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

RICHEN CORTEX EUROPE Srl

Country
OTS 2025
Not Confirmed
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RICHEN CORTEX EUROPE Srl

Country
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OTS 2025
Not Confirmed

Urea C13

Brand Name : Citredici Ubt Kit

Dosage Form : C-13 Urea 75Mg 1 Combined Oral Use

Dosage Strength : 1 bottle os 75 mg + 1 envelope

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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07

AB ANALITICA Srl

Country
OTS 2025
Not Confirmed
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AB ANALITICA Srl

Country
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OTS 2025
Not Confirmed

Urea C13

Brand Name : Breathquality-Ubt

Dosage Form : C-13 Urea 75Mg 10Ml Oral Use

Dosage Strength : os soluz 75 mg 10 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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08

ITC FARMA Srl

Country
OTS 2025
Not Confirmed
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ITC FARMA Srl

Country
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OTS 2025
Not Confirmed

Urea C13

Brand Name : Helicokit

Dosage Form : C-13 Urea 75Mg 18 Units Of Oral Use

Dosage Strength : 18 CPR 75 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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09

Infai Ch Gmbh

Country
OTS 2025
Not Confirmed
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Infai Ch Gmbh

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OTS 2025
Not Confirmed

Carbon(13-C) Urea

Brand Name : Helicobacter Test INFAI

Dosage Form : Diagnostic

Dosage Strength : 75mg

Packaging :

Approval Date : 16/09/1998

Application Number : 54685

Regulatory Info : Allowed

Registration Country : Switzerland

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10

Infai Ch Gmbh

Country
OTS 2025
Not Confirmed
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Infai Ch Gmbh

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OTS 2025
Not Confirmed

Carbon(13-C) Urea

Brand Name : Helicobacter Test INFAI

Dosage Form : Diagnostic

Dosage Strength : 45mg

Packaging :

Approval Date : 16/09/1998

Application Number : 54685

Regulatory Info : Allowed

Registration Country : Switzerland

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