Bayer AG manufactures innovative APIs and pharmaceutical formulations across diverse therapeutic areas.

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01 8Bayer AG
02 1Baxter Healthcare Corporation
03 26CSL Behring
04 1ORIFARM GROUP AS
05 22Octapharma
06 1P & D Pharmaceuticals Limited
07 2Prothya Biosolutions Netherlands Bv
08 3Takeda Pharmaceutical
09 1Zlb Behring Gmbh
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01 12Injection/Infusion Solution
02 1KIT
03 3POWDER FOR SOLUTION
04 3Powder And Solvent For Injectable Solution And Infusion
05 1Powder And Solvent For Injection And Infusion Solution
06 2Powder And Solvent For Injection Solution
07 5Solution
08 2Solution For Infusion
09 36Solution For Injection
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01 18Approved
02 4Authorised
03 1Authorized
04 6Deregistered
05 1Invalid
06 11Marketed
07 2Not Marketed
08 15Prescription
09 4SCHEDULE D
10 3Blank
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01 7Afstyla
02 1BERIPLEX P/N 1000
03 1BERIPLEX P/N 500
04 1Beriate
05 1Beriplast P Combi-Set
06 4Cluvot
07 3Confidex
08 1Factor Vii Baxalta
09 1Fibrogammin Pdr+Solv For Soln For Inf/Inj
10 6Haemate
11 5Jivi
12 2OCTAPLEX
13 2Ocplex
14 3Octanate
15 2Octanate 1000
16 1Octanate 250
17 2Octanate 500
18 1Octaplex 1000 IU
19 1Octaplex 500 IU
20 2Prothromplex
21 2Thyaplex
22 2Tisseel
23 1Tisseel Duo Quick
24 1Tisseel Kit
25 4Voncento
26 8Wilate
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01 4Canada
02 15Estonia
03 5Malta
04 3Moldova
05 13Norway
06 1Spain
07 24Sweden
Bayer AG manufactures innovative APIs and pharmaceutical formulations across diverse therapeutic areas.
Regulatory Info : Prescription
Registration Country : Estonia
Brand Name : Jivi
Dosage Form : Solution For Injection
Dosage Strength : 250IU
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia
Bayer AG manufactures innovative APIs and pharmaceutical formulations across diverse therapeutic areas.
Regulatory Info : Prescription
Registration Country : Estonia
Brand Name : Jivi
Dosage Form : Solution For Injection
Dosage Strength : 500IU
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia
Bayer AG manufactures innovative APIs and pharmaceutical formulations across diverse therapeutic areas.
Regulatory Info : Prescription
Registration Country : Estonia
Brand Name : Jivi
Dosage Form : Solution For Injection
Dosage Strength : 3000IU
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia
Bayer AG manufactures innovative APIs and pharmaceutical formulations across diverse therapeutic areas.
Regulatory Info : Prescription
Registration Country : Estonia
Brand Name : Jivi
Dosage Form : Solution For Injection
Dosage Strength : 2000IU
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia
Bayer AG manufactures innovative APIs and pharmaceutical formulations across diverse therapeutic areas.
Regulatory Info : Prescription
Registration Country : Estonia
Brand Name : Jivi
Dosage Form : Solution For Injection
Dosage Strength : 1000IU
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia
Bayer AG manufactures innovative APIs and pharmaceutical formulations across diverse therapeutic areas.
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 : 2.01E+13
Regulatory Info : Deregistered
Registration Country : Sweden
Bayer AG manufactures innovative APIs and pharmaceutical formulations across diverse therapeutic areas.
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 : 2.00E+13
Regulatory Info : Deregistered
Registration Country : Sweden
Bayer AG manufactures innovative APIs and pharmaceutical formulations across diverse therapeutic areas.
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 : 2.00E+13
Regulatory Info : Deregistered
Registration Country : Sweden
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Regulatory Info : Authorised
Registration Country : Malta
Brand Name : Cluvot
Dosage Form : Powder And Solvent For Injectable Solution And Infusion
Dosage Strength : 250IU
Packaging :
Approval Date : 2014-02-27
Application Number :
Regulatory Info : Authorised
Registration Country : Malta

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Regulatory Info : Authorised
Registration Country : Malta
Brand Name : Cluvot
Dosage Form : Powder And Solvent For Injectable Solution And Infusion
Dosage Strength : 1250IU
Packaging :
Approval Date : 2014-02-27
Application Number :
Regulatory Info : Authorised
Registration Country : Malta

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Regulatory Info : Authorised
Registration Country : Malta
Human Von Willebrand Factor; Human Coagulation Factor Viii
Brand Name : Wilate
Dosage Form : Powder And Solvent For Injection Solution
Dosage Strength : 500IU; 500IU
Packaging :
Approval Date : 2018-01-10
Application Number :
Regulatory Info : Authorised
Registration Country : Malta

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Regulatory Info : Authorised
Registration Country : Malta
Human Von Willebrand Factor; Human Coagulation Factor Viii
Brand Name : Wilate
Dosage Form : Powder And Solvent For Injection Solution
Dosage Strength : 1000IU; 1000IU
Packaging :
Approval Date : 2018-01-10
Application Number :
Regulatory Info : Authorised
Registration Country : Malta

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Regulatory Info :
Registration Country : Moldova
Brand Name : Octanate 250
Dosage Form : Solution For Injection
Dosage Strength : 250IU
Packaging :
Approval Date : 30-04-2020
Application Number :
Regulatory Info :
Registration Country : Moldova

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Regulatory Info :
Registration Country : Moldova
Brand Name : Octanate 500
Dosage Form : Solution For Injection
Dosage Strength : 500IU
Packaging :
Approval Date : 30-04-2020
Application Number :
Regulatory Info :
Registration Country : Moldova

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Regulatory Info :
Registration Country : Moldova
Brand Name : Octanate 1000
Dosage Form : Solution For Injection
Dosage Strength : 1000IU
Packaging :
Approval Date : 30-04-2020
Application Number :
Regulatory Info :
Registration Country : Moldova

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Regulatory Info : Marketed
Registration Country : Norway
Coagulation Factor II, human; Coagulation Factor VII, human; Coagulation Factor IX, human; Coagulation Factor X, human; Protein C, human; Protein S
Brand Name : Octaplex 1000 IU
Dosage Form : Solution For Injection
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway

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Regulatory Info : Marketed
Registration Country : Norway
Coagulation Factor II, human; Coagulation Factor VII, human; Coagulation Factor IX, human; Coagulation Factor X, human; Protein C, human; Protein S
Brand Name : Octaplex 500 IU
Dosage Form : Solution For Injection
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway

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Regulatory Info : Marketed
Registration Country : Norway
Coagulation Factor II, human; Coagulation Factor VII, human; Coagulation Factor IX, human; Coagulation Factor X, human; Protein C, human
Brand Name : Prothromplex
Dosage Form : Solution For Injection
Dosage Strength : 500IU
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway

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Regulatory Info : Not Marketed
Registration Country : Norway
Coagulation Factor II, human; Coagulation Factor VII, human; Coagulation Factor IX, human; Coagulation Factor X, human; Protein C, human
Brand Name : Prothromplex
Dosage Form : Solution For Injection
Dosage Strength : 600IU
Packaging :
Approval Date :
Application Number :
Regulatory Info : Not Marketed
Registration Country : Norway

Regulatory Info : Invalid
Registration Country : Malta
Brand Name : Fibrogammin Pdr+Solv For Soln For Inf/Inj
Dosage Form : Powder And Solvent For Injectable Solution And Infusion
Dosage Strength : 62.5IU/ML
Packaging :
Approval Date : 2016-09-22
Application Number :
Regulatory Info : Invalid
Registration Country : Malta

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