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01 1Baxter Healthcare Corporation
02 3Bayer AG
03 14CSL Behring
04 8Octapharma
05 2Prothya Biosolutions Netherlands Bv
06 1Zlb Behring Gmbh
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01 8Injection/Infusion Solution
02 1KIT
03 3POWDER FOR SOLUTION
04 1Powder And Solvent For Injection And Infusion Solution
05 5Solution
06 2Solution For Infusion
07 9Solution For Injection
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01 18Approved
02 1Authorized
03 6Deregistered
04 4Schedule D
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01 1BERIPLEX P/N 1000
02 1BERIPLEX P/N 500
03 1Beriate
04 1Beriplast P Combi-Set
05 2Cluvot
06 3Confidex
07 2Haemate
08 2OCTAPLEX
09 2Ocplex
10 2Thyaplex
11 2Tisseel
12 1Tisseel Duo Quick
13 1Tisseel Kit
14 4Voncento
15 4Wilate
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01 4Canada
02 1Spain
03 24Sweden
Regulatory Info : Approved
Registration Country : Sweden
Aprotinin Bovine Synthetic; Human Fibrinogen; Calcium Chloride Dihydrate; Human Coagulation Factor XIII; Human Thrombin
Brand Name : Tisseel
Dosage Form : Solution
Dosage Strength :
Packaging :
Approval Date : 29/01/2010
Application Number : 20070210000019
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Aprotinin Bovine; Human Fibrinogen; Calcium Chloride Dihydrate; Human Coagulation Factor XIII; Human Thrombin
Brand Name : Tisseel
Dosage Form : Solution
Dosage Strength :
Packaging :
Approval Date : 26/02/2010
Application Number : 20070210000026
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Aprotinin Bovine; Human Fibrinogen; Human Fibronectin; Calcium Chloride Dihydrate; Human Coagulation Factor XIII; Human Plasminogen; Human Thrombin
Brand Name : Tisseel Kit
Dosage Form : Solution
Dosage Strength :
Packaging :
Approval Date : 19/01/1995
Application Number : 19950119000027
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Aprotinin Bovine; Human Fibrinogen; Human Fibronectin; Calcium Chloride Dihydrate; Human Coagulation Factor XIII; Human Plasminogen; Human Thrombin
Brand Name : Tisseel Duo Quick
Dosage Form : Solution
Dosage Strength :
Packaging :
Approval Date : 19/01/1995
Application Number : 19950119000010
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Coagulation Factor VIII Human; Von Willebrand Factor Human
Brand Name : Haemate
Dosage Form : Injection/Infusion Solution
Dosage Strength : 1000IUFVIII/2400IUVWF
Packaging :
Approval Date : 12/06/1987
Application Number : 19870612000136
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Coagulation Factor VIII Human; Von Willebrand Factor Human
Brand Name : Haemate
Dosage Form : Injection/Infusion Solution
Dosage Strength : 500IUFVIII/1200IUVWF
Packaging :
Approval Date : 12/06/1987
Application Number : 19870612000051
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Coagulation Factor VIII Human; Von Willebrand Factor Human
Brand Name : Voncento
Dosage Form : Injection/Infusion Solution
Dosage Strength : 1000IUFVIII/2400IUVWF
Packaging :
Approval Date : 12/08/2013
Application Number : 20120121000056
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Coagulation Factor VIII Human; Von Willebrand Factor Human
Brand Name : Voncento
Dosage Form : Injection/Infusion Solution
Dosage Strength : 250IEFVIII/600IEVWF
Packaging :
Approval Date : 12/08/2013
Application Number : 20120121000025
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Coagulation Factor VIII Human; Von Willebrand Factor Human
Brand Name : Voncento
Dosage Form : Injection/Infusion Solution
Dosage Strength : 10ml
Packaging :
Approval Date : 12/08/2013
Application Number : 20120121000032
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Coagulation Factor VIII Human; Von Willebrand Factor Human
Brand Name : Voncento
Dosage Form : Injection/Infusion Solution
Dosage Strength : 5ml
Packaging :
Approval Date : 12/08/2013
Application Number : 20120121000049
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 : 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 VIII Human; Von Willebrand Factor Human
Brand Name : Wilate
Dosage Form : Solution For Injection
Dosage Strength : 1000IEVWF/1000IEFVIII
Packaging :
Approval Date : 02/08/2012
Application Number : 20101127000080
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Coagulation Factor VIII Human; Von Willebrand Factor Human
Brand Name : Wilate
Dosage Form : Solution For Injection
Dosage Strength : 500IEVWF/500IEFVIII
Packaging :
Approval Date : 02/08/2012
Application Number : 20101127000073
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Coagulation Factor VIII Human; Von Willebrand Factor Human
Brand Name : Wilate
Dosage Form : Solution For Injection
Dosage Strength : 450IEFVIII/400IEVWF
Packaging :
Approval Date : 31/08/2007
Application Number : 20060826000015
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Coagulation Factor VIII Human; Von Willebrand Factor Human
Brand Name : Wilate
Dosage Form : Solution For Injection
Dosage Strength : 900IEFVIII/800IEVWF
Packaging :
Approval Date : 31/08/2007
Application Number : 20060826000022
Regulatory Info : Deregistered
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 : Deregistered
Registration Country : Sweden
Aprotinin Bovine; Human Fibrinogen; Calcium Chloride Dihydrate; Human Coagulation Factor XIII; Human Thrombin
Brand Name : Beriplast P Combi-Set
Dosage Form : Solution
Dosage Strength :
Packaging :
Approval Date : 10/08/2001
Application Number : 20010810000125
Regulatory Info : Deregistered
Registration Country : Sweden
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