01 1Adcock Ingram
02 6Bayer AG
03 3CSL Behring
04 3Grifols International
05 3National Bioproducts Institute
06 1Novo Nordisk
07 3Octapharma
08 4Stragen Pharma SA
01 1INF
02 7INJ
03 6POI
04 2Powder And Solvent For Injectable Solution Or Infusion
05 1Powder And Solvent For Injection And Infusion Solution
06 3Powder And Solvent For Injection Solution
07 4Powder and Solvent for Solution for Injection
01 6Authorized
02 3Generic
03 11Originator
04 4Blank
01 1Beriate
02 3Fanhdi
03 2Haemate P
04 1Haemosolvate Factor VIII 300 IU
05 2Haemosolvate Factor VIII 500 IU
06 1Hemofil-M Factor VIII
07 1Kogenate Fs 1000
08 1Kogenate Fs 250
09 1Kogenate Fs 500
10 1Kovaltry 1000
11 1Kovaltry 250
12 1Kovaltry 500
13 1NovoSeven
14 1Octanate 1 000
15 1Octanate 250
16 1Octanate 500
17 4Blank
01 14South Africa
02 6Spain
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 : Authorized
Registration Country : Spain
Factor Viii; Water For Injectable Preparations
Brand Name : Beriate
Dosage Form : Powder And Solvent For Injection And Infusion Solution
Dosage Strength : 1000IU
Packaging :
Approval Date : 2000-04-18
Application Number : 63009
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Factor Viii; Von Willebrand Factor
Brand Name : Haemate P
Dosage Form : Powder And Solvent For Injectable Solution Or Infusion
Dosage Strength : 2400IU; 1000 IU
Packaging :
Approval Date : 1986-01-01
Application Number : 56868
Regulatory Info : Authorized
Registration Country : Spain
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 : 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 : Originator
Registration Country : South Africa
Brand Name : Octanate 500
Dosage Form : INJ
Dosage Strength : 500IU/10 ml
Packaging : 10X1IU/10 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 :
