01 8NTP Radioisotopes Soc Ltd
02 1Progenics Pharmaceuticals
01 8INJ
02 1SOLUTION;INTRAVENOUS
01 1DISCN
02 8Originator
01 1AZEDRA
02 3Mibg Diagnostic
03 5Mibg For Therapy
01 8South Africa
02 1USA
Regulatory Info : Originator
Registration Country : South Africa
(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
Regulatory Info : Originator
Registration Country : South Africa
(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
Regulatory Info : Originator
Registration Country : South Africa
(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
Regulatory Info : Originator
Registration Country : South Africa
(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
Regulatory Info : Originator
Registration Country : South Africa
(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
Regulatory Info : Originator
Registration Country : South Africa
(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
Regulatory Info : Originator
Registration Country : South Africa
(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
Regulatory Info : Originator
Registration Country : South Africa
(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
Regulatory Info : DISCN
Registration Country : USA
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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