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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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PharmaCompass

01

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

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

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02

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

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

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03

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

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

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04

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

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

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05

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

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

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06

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Nonacogum Alpha

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

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07

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Nonacogum Alpha

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

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08

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Nonacogum Alpha

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

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09

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Nonacogum Alpha

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

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10

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Nonacogum Alpha

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

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11

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Nonakog Alfa

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

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12

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Nonakog Alfa

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

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13

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Nonakog Alfa

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

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14

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Nonakog Alfa

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

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15

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Nonakog Alfa

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

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16

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

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 :

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17

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

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 :

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18

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

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 :

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19

Prothya Biosolutions Netherlands Bv

Country
Aus. Peptide Conference
Not Confirmed
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Prothya Biosolutions Netherlands Bv

Country
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Aus. Peptide Conference
Not Confirmed

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

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20

Prothya Biosolutions Netherlands Bv

Country
Aus. Peptide Conference
Not Confirmed
arrow

Prothya Biosolutions Netherlands Bv

Country
arrow
Aus. Peptide Conference
Not Confirmed

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

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