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01 2Baxalta Innovations GmbH

02 3Csl Behring Gmbh

03 2Octapharma (2)

04 2Octapharma Ab

05 2Prothya Biosolutions Netherlands Bv

06 2Takeda Manufacturing Austria AG

07 2Takeda Manufacturing Austria Ag

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PharmaCompass

01

IPPE
Not Confirmed
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IPPE
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

IPPE
Not Confirmed
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IPPE
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

IPPE
Not Confirmed
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IPPE
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

IPPE
Not Confirmed
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IPPE
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

IPPE
Not Confirmed
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IPPE
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

IPPE
Not Confirmed
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IPPE
Not Confirmed

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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07

IPPE
Not Confirmed
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IPPE
Not Confirmed

Protein C (Human)

Brand Name : Ceprotin

Dosage Form : Solution For Injection

Dosage Strength : 1000IE

Packaging :

Approval Date : 16/07/2001

Application Number : 20010716000021

Regulatory Info : Approved

Registration Country : Sweden

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08

IPPE
Not Confirmed
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IPPE
Not Confirmed

Protein C (Human)

Brand Name : Ceprotin

Dosage Form : Solution For Injection

Dosage Strength : 500IU

Packaging :

Approval Date : 16/07/2001

Application Number : 20010716000014

Regulatory Info : Approved

Registration Country : Sweden

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09

Prothya Biosolutions Netherlands Bv

Country
IPPE
Not Confirmed
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Prothya Biosolutions Netherlands Bv

Country
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IPPE
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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10

Prothya Biosolutions Netherlands Bv

Country
IPPE
Not Confirmed
arrow

Prothya Biosolutions Netherlands Bv

Country
arrow
IPPE
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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