01 1Adcock Ingram
02 6Bayer AG
03 3National Bioproducts Institute
04 1Novo Nordisk
05 6Octapharma
06 4Stragen Pharma SA
01 1INF
02 7INJ
03 6POI
04 4Powder and Solvent for Solution for Injection
05 3Vial
01 3Generic
02 11Originator
03 7Blank
01 1Haemosolvate Factor VIII 300 IU
02 2Haemosolvate Factor VIII 500 IU
03 1Hemofil-M Factor VIII
04 1Kogenate Fs 1000
05 1Kogenate Fs 250
06 1Kogenate Fs 500
07 1Kovaltry 1000
08 1Kovaltry 250
09 1Kovaltry 500
10 1NovoSeven
11 3Octanate
12 1Octanate 1 000
13 1Octanate 250
14 1Octanate 500
15 4Blank
01 14South Africa
02 3Switzerland
03 4Blank
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Hemofil-M Factor VIII
Dosage Form : INJ
Dosage Strength : 1ZZZ
Packaging : 448X1ZZZ
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Kovaltry 250
Dosage Form : POI
Dosage Strength : 250ML
Packaging : 1X1ML
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Kovaltry 500
Dosage Form : POI
Dosage Strength : 500ML
Packaging : 1X1ML
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Kovaltry 1000
Dosage Form : POI
Dosage Strength : 1000ML
Packaging : 1X1ML
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Kogenate Fs 250
Dosage Form : INJ
Dosage Strength : 250mg
Packaging : 10X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Kogenate Fs 500
Dosage Form : INJ
Dosage Strength : 500mg
Packaging : 10X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Kogenate Fs 1000
Dosage Form : INJ
Dosage Strength : 1000mg
Packaging : 10X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Haemosolvate Factor VIII 500 IU
Dosage Form : POI
Dosage Strength : 500iu
Packaging : 10X1iu
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Haemosolvate Factor VIII 500 IU
Dosage Form : POI
Dosage Strength : 500iu
Packaging : 10X2iu
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Haemosolvate Factor VIII 300 IU
Dosage Form : POI
Dosage Strength : 300iu
Packaging : 10X1iu
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : NovoSeven
Dosage Form : INF
Dosage Strength : 2mg
Packaging : 2X1mg/2ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : Switzerland
Brand Name : Octanate
Dosage Form : Vial
Dosage Strength : 250IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Octanate
Dosage Form : Vial
Dosage Strength : 500IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Octanate
Dosage Form : Vial
Dosage Strength : 1000IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Octanate 1 000
Dosage Form : INJ
Dosage Strength : 1000IU/10 ml
Packaging : 10X1IU/10 ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Octanate 250
Dosage Form : INJ
Dosage Strength : 250IU/5 ml
Packaging : 5X1IU/5 ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country :
Brand Name :
Dosage Form : Powder and Solvent for Solution for Injection
Dosage Strength : 250IU
Packaging : 1 vial of powder + 1 vial of solvent + 1 injection kit
Approval Date :
Application Number :
Regulatory Info :
Registration Country :
Regulatory Info :
Registration Country :
Brand Name :
Dosage Form : Powder and Solvent for Solution for Injection
Dosage Strength : 500IU
Packaging : 1 vial of powder + 1 vial of solvent + 1 injection kit
Approval Date :
Application Number :
Regulatory Info :
Registration Country :
Regulatory Info :
Registration Country :
Brand Name :
Dosage Form : Powder and Solvent for Solution for Injection
Dosage Strength : 1000IU
Packaging : 1 vial of powder + 1 vial of solvent + 1 injection kit
Approval Date :
Application Number :
Regulatory Info :
Registration Country :
Regulatory Info :
Registration Country :
Brand Name :
Dosage Form : Powder and Solvent for Solution for Injection
Dosage Strength : 2000IU
Packaging : 1 vial of powder + 1 vial of solvent + 1 injection kit
Approval Date :
Application Number :
Regulatory Info :
Registration Country :
