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01 1AB ANALITICA Srl

02 1DXS DEVICES

03 1Ferrer Internacional

04 5INFAI GmbH (1)

05 3ITC FARMA Srl

06 2Infai Ch Gmbh

07 4Infai Gmbh

08 1Isomed Pharma Sl

09 4Mayoly Spindler

10 1Meridian Bioscience

11 1Metabolic Solutions

12 2Otsuka America Pharmaceutical, Inc.

13 1RICHEN CORTEX EUROPE Srl

14 2Sofar Spa

15 1Torbet Laboratories Ireland Limited

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PharmaCompass

01

IPPE
Not Confirmed
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IPPE
Not Confirmed

Urea (13C)

Brand Name : Diabact UBT

Dosage Form : Tablet

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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02

IPPE
Not Confirmed
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IPPE
Not Confirmed

Urea (13C)

Brand Name : Diabact UBT

Dosage Form : Tablet

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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03

IPPE
Not Confirmed
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IPPE
Not Confirmed

CITRIC ACID; UREA C-13

Brand Name : IDKIT:HP

Dosage Form : FOR SOLUTION, TABLET, FOR SOLUTION;ORAL

Dosage Strength : 4GM;75MG

Packaging :

Approval Date : 2002-12-17

Application Number : 21314

Regulatory Info : RX

Registration Country : USA

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04

IPPE
Not Confirmed
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IPPE
Not Confirmed

UREA C-13

Brand Name : HELICOSOL

Dosage Form : FOR SOLUTION;ORAL

Dosage Strength : 125MG/VIAL

Packaging :

Approval Date : 1999-12-17

Application Number : 21092

Regulatory Info : DISCN

Registration Country : USA

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05

IPPE
Not Confirmed
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IPPE
Not Confirmed

UREA C-13

Brand Name : MERETEK UBT KIT (W/ PRANACTIN)

Dosage Form : FOR SOLUTION;ORAL

Dosage Strength : 125MG/VIAL

Packaging :

Approval Date : 1996-09-17

Application Number : 20586

Regulatory Info : DISCN

Registration Country : USA

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06

IPPE
Not Confirmed
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IPPE
Not Confirmed

UREA C-13

Brand Name : BREATHTEK UBT FOR H-PYLORI

Dosage Form : FOR SOLUTION;ORAL

Dosage Strength : EQ 75MG/POUCH

Packaging :

Approval Date : 2001-05-10

Application Number : 20586

Regulatory Info : DISCN

Registration Country : USA

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07

IPPE
Not Confirmed
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IPPE
Not Confirmed

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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08

IPPE
Not Confirmed
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IPPE
Not Confirmed

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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09

DXS DEVICES

Country
IPPE
Not Confirmed
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DXS DEVICES

Country
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IPPE
Not Confirmed

UREA C-13

Brand Name : PYLORI-CHEK BREATH TEST

Dosage Form : FOR SOLUTION;ORAL

Dosage Strength : 100MG/VIAL

Packaging :

Approval Date : 1999-02-04

Application Number : 20900

Regulatory Info : DISCN

Registration Country : USA

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10

ITC FARMA Srl

Country
IPPE
Not Confirmed
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ITC FARMA Srl

Country
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IPPE
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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11

ITC FARMA Srl

Country
IPPE
Not Confirmed
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ITC FARMA Srl

Country
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IPPE
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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12

RICHEN CORTEX EUROPE Srl

Country
IPPE
Not Confirmed
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RICHEN CORTEX EUROPE Srl

Country
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IPPE
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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13

AB ANALITICA Srl

Country
IPPE
Not Confirmed
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AB ANALITICA Srl

Country
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IPPE
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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14

ITC FARMA Srl

Country
IPPE
Not Confirmed
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ITC FARMA Srl

Country
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IPPE
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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15

Infai Ch Gmbh

Country
IPPE
Not Confirmed
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Infai Ch Gmbh

Country
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IPPE
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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16

Infai Ch Gmbh

Country
IPPE
Not Confirmed
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Infai Ch Gmbh

Country
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IPPE
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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17

INFAI GmbH (1)

Country
IPPE
Not Confirmed
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INFAI GmbH (1)

Country
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IPPE
Not Confirmed

Urea (13C)

Brand Name : Helicobacter Test INFAI

Dosage Form : Powder For Oral Solution

Dosage Strength : 45mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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18

INFAI GmbH (1)

Country
IPPE
Not Confirmed
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INFAI GmbH (1)

Country
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IPPE
Not Confirmed

Urea (13C)

Brand Name : Helicobacter Test INFAI

Dosage Form : Powder For Oral Solution

Dosage Strength : 75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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19

INFAI GmbH (1)

Country
IPPE
Not Confirmed
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INFAI GmbH (1)

Country
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IPPE
Not Confirmed

Urea (13C)

Brand Name : Helicobacter Test INFAI

Dosage Form : Powder For Oral Solution

Dosage Strength : 75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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20

INFAI GmbH (1)

Country
IPPE
Not Confirmed
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INFAI GmbH (1)

Country
arrow
IPPE
Not Confirmed

Urea (13C)

Brand Name : Helicobacter Test INFAI

Dosage Form : Powder For Oral Solution

Dosage Strength : 75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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