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01 1Lantheus Holding

02 8NTP Radioisotopes Soc Ltd

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PharmaCompass

01

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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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02

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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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03

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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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04

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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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05

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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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06

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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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07

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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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08

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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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09

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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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