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01 3CSL Behring
02 5Octapharma
03 20Pfizer Inc
04 2Prothya Biosolutions Netherlands Bv
05 3Stragen Pharma SA
06 3Takeda Pharmaceutical
07 3Wyeth Europe Ltd
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01 3INJ
02 1KIT
03 6POWDER FOR SOLUTION
04 5Powder And Solvent For Injectable Solution
05 5Powder For Injection
06 3Powder and Solvent for Solution for Injection
07 2Solution For Infusion
08 14Solution For Injection
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01 5Allowed
02 13Approved
03 5Authorized
04 3Deregistered
05 3Originator
06 7Schedule D
07 3Blank
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01 4BENEFIX
02 5BeneFIX
03 14Benefix
04 3Confidex
05 2Ocplex
06 1Octanine F 1 000
07 1Octanine F 250
08 1Octanine F 500
09 3RIXUBIS
10 2Thyaplex
11 3Blank
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01 7Canada
02 3South Africa
03 5Spain
04 16Sweden
05 5Switzerland
06 3Blank
Regulatory Info : Approved
Registration Country : Sweden
Coagulation Factor II (Prothrombin, Human); Factor IX (Human); Factor VII (Human); Factor X (Human); Protein C (Human); Protein S (Human)
Brand Name : Confidex
Dosage Form : Solution For Injection
Dosage Strength : 1000IE
Packaging :
Approval Date : 29/08/2013
Application Number : 20120705000069
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Coagulation Factor II (Prothrombin, Human); Factor IX (Human); Factor VII (Human); Factor X (Human); Protein C (Human); Protein S (Human)
Brand Name : Confidex
Dosage Form : Solution For Injection
Dosage Strength : 250IE
Packaging :
Approval Date : 09/05/2008
Application Number : 20071006000084
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Coagulation Factor II (Prothrombin, Human); Factor IX (Human); Factor VII (Human); Factor X (Human); Protein C (Human); Protein S (Human)
Brand Name : Confidex
Dosage Form : Solution For Injection
Dosage Strength : 500IU
Packaging :
Approval Date : 09/05/2008
Application Number : 20071006000091
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Coagulation Factor II (Prothrombin, Human); Factor IX (Human); Factor VII (Human); Factor X (Human); Protein C (Human); Protein S (Human)
Brand Name : Ocplex
Dosage Form : Solution For Infusion
Dosage Strength : 1000IE
Packaging :
Approval Date : 17/09/2015
Application Number : 20140910000067
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Coagulation Factor II (Prothrombin, Human); Factor IX (Human); Factor VII (Human); Factor X (Human); Protein C (Human); Protein S (Human)
Brand Name : Ocplex
Dosage Form : Solution For Infusion
Dosage Strength : 500IU
Packaging :
Approval Date : 23/07/2004
Application Number : 20040607006917
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : BeneFIX
Dosage Form : Powder For Injection
Dosage Strength : 250IU
Packaging :
Approval Date : 26/02/1998
Application Number : 54510
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : BeneFIX
Dosage Form : Powder For Injection
Dosage Strength : 500IU
Packaging :
Approval Date : 26/02/1998
Application Number : 54510
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : BeneFIX
Dosage Form : Powder For Injection
Dosage Strength : 000IU
Packaging :
Approval Date : 26/02/1998
Application Number : 54510
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : BeneFIX
Dosage Form : Powder For Injection
Dosage Strength : 000IU
Packaging :
Approval Date : 26/02/1998
Application Number : 54510
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : BeneFIX
Dosage Form : Powder For Injection
Dosage Strength : 3000IU
Packaging :
Approval Date : 26/02/1998
Application Number : 54510
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Benefix
Dosage Form : Solution For Injection
Dosage Strength : 1000IE
Packaging :
Approval Date : 30/07/2007
Application Number : 20070824000047
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Benefix
Dosage Form : Solution For Injection
Dosage Strength : 1500IU
Packaging :
Approval Date : 22/03/2017
Application Number : 20160916000052
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Benefix
Dosage Form : Solution For Injection
Dosage Strength : 2000IE
Packaging :
Approval Date : 30/07/2007
Application Number : 20060616000034
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Benefix
Dosage Form : Solution For Injection
Dosage Strength : 250IE
Packaging :
Approval Date : 30/07/2007
Application Number : 20070824000023
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Benefix
Dosage Form : Solution For Injection
Dosage Strength : 3000IU
Packaging :
Approval Date : 23/08/2012
Application Number : 20110809000249
Regulatory Info : Approved
Registration Country : Sweden
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 : Approved
Registration Country : Sweden
Coagulation Factor II (Prothrombin, Human); Factor IX (Human); Factor VII (Human); Factor X (Human); Protein C (Human); Protein S (Human)
Brand Name : Thyaplex
Dosage Form : Solution For Injection
Dosage Strength : 250IE
Packaging :
Approval Date : 09/05/2022
Application Number : 20210720000035
Regulatory Info : Approved
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Approved
Registration Country : Sweden
Coagulation Factor II (Prothrombin, Human); Factor IX (Human); Factor VII (Human); Factor X (Human); Protein C (Human); Protein S (Human)
Brand Name : Thyaplex
Dosage Form : Solution For Injection
Dosage Strength : 500IU
Packaging :
Approval Date : 09/05/2022
Application Number : 20210720000042
Regulatory Info : Approved
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF