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01 1Cherubino Limited

02 3GE Healthcare Inc

03 1Lantheus Holding

04 8NTP Radioisotopes Soc Ltd

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PharmaCompass

01

Cell Bio
Not Confirmed
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Cell Bio
Not Confirmed

Iobenguano 131I

Brand Name : Metaiodebenzylguanidine (131I) For Diagnostic Use Ge Healthcare

Dosage Form : Injectable Solution

Dosage Strength : 18.5MBQ

Packaging :

Approval Date : 2007-12-10

Application Number : 69364

Regulatory Info : Suspensed

Registration Country : Spain

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02

Cell Bio
Not Confirmed
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Cell Bio
Not Confirmed

Iobenguano 131I

Brand Name : Metaiodebenzylguanidine (131I) For Diagnostic Use Ge Healthcare

Dosage Form : Solution

Dosage Strength : 493.3MBQ

Packaging :

Approval Date : 2007-10-16

Application Number : 69329

Regulatory Info : Suspensed

Registration Country : Spain

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03

Cell Bio
Not Confirmed
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Cell Bio
Not Confirmed

Iobenguane

Brand Name : [¹³¹I] Meta-Iodobenzylguanidine For Diagnostic Use

Dosage Form : Solution For Injection

Dosage Strength :

Packaging :

Approval Date : 2007-09-03

Application Number :

Regulatory Info : Withdrawn

Registration Country : Malta

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04

Cell Bio
Not Confirmed
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Cell Bio
Not Confirmed

IOBENGUANE I-131

Brand Name : AZEDRA

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 15mCi/ML

Packaging :

Approval Date : 2018-07-30

Application Number : 209607

Regulatory Info : DISCN

Registration Country : USA

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05

Cell Bio
Not Confirmed
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Cell Bio
Not Confirmed

(Meta) Iodo Benzylguanidine I-131

Brand Name : Mibg For Therapy

Dosage Form : INJ

Dosage Strength : 11100MBq

Packaging : 3X1MBq

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

Cell Bio
Not Confirmed
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Cell Bio
Not Confirmed

(Meta) Iodo Benzylguanidine I-131

Brand Name : Mibg Diagnostic

Dosage Form : INJ

Dosage Strength : 19MBq

Packaging : 2X1MBq

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

Cell Bio
Not Confirmed
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Cell Bio
Not Confirmed

(Meta) Iodo Benzylguanidine I-131

Brand Name : Mibg Diagnostic

Dosage Form : INJ

Dosage Strength : 37MBq

Packaging : 2X1MBq

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

Cell Bio
Not Confirmed
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Cell Bio
Not Confirmed

(Meta) Iodo Benzylguanidine I-131

Brand Name : Mibg Diagnostic

Dosage Form : INJ

Dosage Strength : 185MBq

Packaging : 2X1MBq

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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09

Cell Bio
Not Confirmed
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Cell Bio
Not Confirmed

(Meta) Iodo Benzylguanidine I-131

Brand Name : Mibg For Therapy

Dosage Form : INJ

Dosage Strength : 3700MBq

Packaging : 3X1MBq

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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10

Cell Bio
Not Confirmed
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Cell Bio
Not Confirmed

(Meta) Iodo Benzylguanidine I-131

Brand Name : Mibg For Therapy

Dosage Form : INJ

Dosage Strength : 5550MBq

Packaging : 3X1MBq

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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11

Cell Bio
Not Confirmed
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Cell Bio
Not Confirmed

(Meta) Iodo Benzylguanidine I-131

Brand Name : Mibg For Therapy

Dosage Form : INJ

Dosage Strength : 7400MBq

Packaging : 3X1MBq

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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12

Cell Bio
Not Confirmed
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Cell Bio
Not Confirmed

(Meta) Iodo Benzylguanidine I-131

Brand Name : Mibg For Therapy

Dosage Form : INJ

Dosage Strength : 1850MBq

Packaging : 3X1MBq

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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13

Cherubino Limited

Country
Cell Bio
Not Confirmed
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Cherubino Limited

Country
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Cell Bio
Not Confirmed

Iobenguane

Brand Name : Metaiodobenzylguanidine-131I (Mibg-131I) For Diagnostic Use,

Dosage Form : Solution For Injection

Dosage Strength : 10-37MEGABECQUEREL/ML

Packaging :

Approval Date : 2022-09-22

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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