01 2Baxter Healthcare Corporation
02 4Bayer AG
03 2CSL Behring
04 5Octapharma
05 9Pfizer Inc
06 1Sanquin Plasma Products BV
07 3Stragen Pharma SA
08 10Takeda Pharmaceutical
01 8Dry Sub
02 3INJ
03 5KIT
04 1POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
05 10POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
06 4POWDER FOR SOLUTION
07 3Powder and Solvent for Solution for Injection
08 2Trockensub
01 3Originator
02 9Schedule D
03 24Blank
01 4BENEFIX
02 5Benefix
03 2Cluvot
04 6Immunine
05 2Nanofix
06 1Nonafact
07 1Octanine F 1 000
08 1Octanine F 250
09 1Octanine F 500
10 5RIXUBIS
11 5Rixubis
12 3Blank
01 9Canada
02 3South Africa
03 11Sweden
04 10Switzerland
05 3Blank
Regulatory Info :
Registration Country : Sweden
Brand Name : Immunine
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Dosage Strength : 600 IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Immunine
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Dosage Strength : 1200 IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Immunine
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Dosage Strength : 200 IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Immunine
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Dosage Strength : 1200 IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Immunine
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Dosage Strength : 600 IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Immunine
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Dosage Strength : 200 IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
coagulation factor XIII, human
Brand Name : Cluvot
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Dosage Strength : 250 IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
coagulation factor XIII, human
Brand Name : Cluvot
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Dosage Strength : 1250 IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Nanofix
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Dosage Strength : 500 IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Nanofix
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Dosage Strength : 1000 IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Switzerland
Brand Name : Benefix
Dosage Form : Dry Sub
Dosage Strength : 250iu
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Benefix
Dosage Form : Dry Sub
Dosage Strength : 500iu
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Benefix
Dosage Form : Dry Sub
Dosage Strength : 1000iu
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Benefix
Dosage Form : Dry Sub
Dosage Strength : 2000iu
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Benefix
Dosage Form : Dry Sub
Dosage Strength : 3000iu
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Schedule D
Registration Country : Canada
COAGULATION FACTOR IX (RECOMBINANT)
Brand Name : BENEFIX
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 3000UNIT/VIAL
Packaging :
Approval Date :
Application Number : 2392984
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info :
Registration Country :
Coagulation Factor IX Recombinant
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 :
Coagulation Factor IX Recombinant
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 :
Coagulation Factor IX Recombinant
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 : Switzerland
Brand Name : Rixubis
Dosage Form : Dry Sub
Dosage Strength : 1000iu
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Rixubis
Dosage Form : Dry Sub
Dosage Strength : 2000iu
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Rixubis
Dosage Form : Trockensub
Dosage Strength : 250iu
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Rixubis
Dosage Form : Dry Sub
Dosage Strength : 3000iu
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Rixubis
Dosage Form : Trockensub
Dosage Strength : 500iu
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : RIXUBIS
Dosage Form : KIT
Dosage Strength : 250UNIT/VIAL
Packaging :
Approval Date :
Application Number : 2431920
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : RIXUBIS
Dosage Form : KIT
Dosage Strength : 500UNIT/VIAL
Packaging :
Approval Date :
Application Number : 2431939
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : RIXUBIS
Dosage Form : KIT
Dosage Strength : 1000UNIT/VIAL
Packaging :
Approval Date :
Application Number : 2431947
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : RIXUBIS
Dosage Form : KIT
Dosage Strength : 2000UNIT/VIAL
Packaging :
Approval Date :
Application Number : 2431955
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : RIXUBIS
Dosage Form : KIT
Dosage Strength : 3000UNIT/VIAL
Packaging :
Approval Date :
Application Number : 2431963
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info :
Registration Country : Sweden
Brand Name : Nonafact
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
Dosage Strength : 100 IU / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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