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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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PharmaCompass

01

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

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

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02

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

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

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03

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

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

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04

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

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

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05

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

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

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06

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

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

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07

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

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

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08

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

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

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09

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

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

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10

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

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

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11

Organic Process R&D
Not Confirmed
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Organic Process R&D
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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12

Organic Process R&D
Not Confirmed
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Organic Process R&D
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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13

Organic Process R&D
Not Confirmed
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Organic Process R&D
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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14

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

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

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15

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

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

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16

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

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

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17

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

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

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18

Organic Process R&D
Not Confirmed
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Organic Process R&D
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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19

Organic Process R&D
Not Confirmed
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Organic Process R&D
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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20

Zlb Behring Gmbh

Country
Organic Process R&D
Not Confirmed
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Zlb Behring Gmbh

Country
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Organic Process R&D
Not Confirmed

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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