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01 1Baxter Healthcare Corporation

02 8Bayer AG

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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PharmaCompass

01

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
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Human Coagulation Factor Xiii

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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02

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

Human Coagulation Factor Xiii

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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03

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

Coagulation factor VIII, human; von Willebrand factor, human

Brand Name : Haemate

Dosage Form : Injection/Infusion Solution

Dosage Strength : 1000IU; 2400IU

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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04

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

Coagulation factor VIII, human; von Willebrand factor, human

Brand Name : Haemate

Dosage Form : Injection/Infusion Solution

Dosage Strength : 250IU; 600IU

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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05

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

Coagulation factor VIII, human; von Willebrand factor, human

Brand Name : Haemate

Dosage Form : Injection/Infusion Solution

Dosage Strength : 500IU; 1200IU

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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06

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
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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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07

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

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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08

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

Human coagulation factor VIII

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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09

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

Human coagulation factor VIII

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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10

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

Human coagulation factor VIII

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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11

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
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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12

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
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 500 IU

Dosage Form : Solution For Injection

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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13

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

Coagulation factor VIII, human

Brand Name : Octanate

Dosage Form : Solution For Injection

Dosage Strength : 1000IU

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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14

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

Coagulation factor VIII, human

Brand Name : Octanate

Dosage Form : Solution For Injection

Dosage Strength : 250IU

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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15

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

Coagulation factor VIII, human

Brand Name : Octanate

Dosage Form : Solution For Injection

Dosage Strength : 500IU

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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16

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

Coagulation factor VIII, human; von Willebrand factor, human

Brand Name : Wilate

Dosage Form : Solution For Injection

Dosage Strength : 1000IU; 1000IU

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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17

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

Coagulation factor VIII, human; von Willebrand factor, human

Brand Name : Haemate

Dosage Form : Injection/Infusion Solution

Dosage Strength : 1000IU; 2400IU

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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18

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

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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19

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

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

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20

P & D Pharmaceuticals Limited

Country
euroPLX 90 Lisbon
Not Confirmed
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P & D Pharmaceuticals Limited

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euroPLX 90 Lisbon
Not Confirmed

Human Coagulation Factor Xiii

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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