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    Coagulation Factor X

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

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    01 1Baxter Healthcare Corporation

    02 3Bayer AG

    03 2Bio Products Laboratory

    04 5CSL Behring

    05 9Octapharma

    06 1Sanquin Plasma Products Bv

    07 3Takeda Pharmaceutical

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    01

    Baxter Healthcare Corporation

    U.S.A
    ISPE Annual Meeting
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    Baxter Healthcare Corporation

    U.S.A
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Coagulation Factor Ix, Human

    Brand Name : Immunine

    Dosage Form : Injection/Infusion Solution

    Dosage Strength : 200IE

    Packaging :

    Approval Date : 16/05/2008

    Application Number : 20070719000039

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    02

    Bayer AG

    Germany
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    Bayer AG

    Germany
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Coagulation Factor Ix, Human

    Brand Name : Immunine

    Dosage Form : Solution For Injection

    Dosage Strength : 1200IU

    Packaging :

    Approval Date : 03/07/1992

    Application Number : 19920703000092

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    03

    Bayer AG

    Germany
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    Bayer AG

    Germany
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Coagulation Factor Ix, Human

    Brand Name : Immunine

    Dosage Form : Solution For Injection

    Dosage Strength : 200IE

    Packaging :

    Approval Date : 03/07/1992

    Application Number : 19920703000078

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    04

    Bayer AG

    Germany
    ISPE Annual Meeting
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    Bayer AG

    Germany
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Coagulation Factor Ix, Human

    Brand Name : Immunine

    Dosage Form : Solution For Injection

    Dosage Strength : 600IU

    Packaging :

    Approval Date : 03/07/1992

    Application Number : 19920703000085

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    05

    Bio Products Laboratory

    United Kingdom
    ISPE Annual Meeting
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    Bio Products Laboratory

    United Kingdom
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    Regulatory Info : Approved

    Registration Country : Sweden

    Coagulation Factor X (Human)

    Brand Name : Coagadex

    Dosage Form : Solution For Injection

    Dosage Strength : 250IE

    Packaging :

    Approval Date : 16/03/2016

    Application Number : 20150725000015

    Regulatory Info : Approved

    Registration Country : Sweden

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    06

    Bio Products Laboratory

    United Kingdom
    ISPE Annual Meeting
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    Bio Products Laboratory

    United Kingdom
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    Regulatory Info : Approved

    Registration Country : Sweden

    Coagulation Factor X (Human)

    Brand Name : Coagadex

    Dosage Form : Solution For Injection

    Dosage Strength : 500IU

    Packaging :

    Approval Date : 16/03/2016

    Application Number : 20160225000019

    Regulatory Info : Approved

    Registration Country : Sweden

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    07

    CSL Behring

    U.S.A
    ISPE Annual Meeting
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    CSL Behring

    U.S.A
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Coagulation Factor Ix, Human

    Brand Name : Mononine

    Dosage Form : Injection/Infusion Solution

    Dosage Strength : 100IU/ml

    Packaging :

    Approval Date : 03/12/1993

    Application Number : 19931203000116

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    08

    CSL Behring

    U.S.A
    ISPE Annual Meeting
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    CSL Behring

    U.S.A
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    Regulatory Info : Schedule D

    Registration Country : Canada

    COAGULATION FACTOR IX (HUMAN)

    Brand Name : BERIPLEX P/N 500

    Dosage Form : POWDER FOR SOLUTION

    Dosage Strength : 620UNIT

    Packaging : 30ML

    Approval Date :

    Application Number : 2359251

    Regulatory Info : Schedule D

    Registration Country : Canada

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    09

    CSL Behring

    U.S.A
    ISPE Annual Meeting
    Not Confirmed
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    CSL Behring

    U.S.A
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    ISPE Annual Meeting
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    Regulatory Info : Schedule D

    Registration Country : Canada

    COAGULATION FACTOR X (HUMAN)

    Brand Name : BERIPLEX P/N 500

    Dosage Form : POWDER FOR SOLUTION

    Dosage Strength : 1020UNIT

    Packaging : 30ML

    Approval Date :

    Application Number : 2359251

    Regulatory Info : Schedule D

    Registration Country : Canada

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    10

    Octapharma

    Switzerland
    ISPE Annual Meeting
    Not Confirmed
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    Octapharma

    Switzerland
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    ISPE Annual Meeting
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    Regulatory Info : Approved

    Registration Country : Sweden

    Coagulation Factor Ix, Human

    Brand Name : Nanofix

    Dosage Form : Solution For Injection

    Dosage Strength : 1000IE

    Packaging :

    Approval Date : 13/08/2010

    Application Number : 20091216000087

    Regulatory Info : Approved

    Registration Country : Sweden

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    11

    Octapharma

    Switzerland
    ISPE Annual Meeting
    Not Confirmed
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    Octapharma

    Switzerland
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    ISPE Annual Meeting
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    Regulatory Info : Approved

    Registration Country : Sweden

    Coagulation Factor Ix, Human

    Brand Name : Nanofix

    Dosage Form : Solution For Injection

    Dosage Strength : 500IU

    Packaging :

    Approval Date : 13/08/2010

    Application Number : 20091216000070

    Regulatory Info : Approved

    Registration Country : Sweden

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    12

    Octapharma

    Switzerland
    ISPE Annual Meeting
    Not Confirmed
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    Octapharma

    Switzerland
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    ISPE Annual Meeting
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Coagulation Factor Ix, Human

    Brand Name : Faktor Ix Octapharma

    Dosage Form : Solution For Injection

    Dosage Strength :

    Packaging :

    Approval Date : 14/06/2002

    Application Number : 20020614000153

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    13

    Octapharma

    Switzerland
    ISPE Annual Meeting
    Not Confirmed
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    Octapharma

    Switzerland
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    ISPE Annual Meeting
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Coagulation Factor Ix, Human

    Brand Name : Nanotive

    Dosage Form : Solution For Injection

    Dosage Strength : 1000IE

    Packaging :

    Approval Date : 24/04/1992

    Application Number : 19920424000067

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    14

    Octapharma

    Switzerland
    ISPE Annual Meeting
    Not Confirmed
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    Octapharma

    Switzerland
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    ISPE Annual Meeting
    Not Confirmed
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Coagulation Factor Ix, Human

    Brand Name : Nanotive

    Dosage Form : Solution For Injection

    Dosage Strength : 500IU

    Packaging :

    Approval Date : 24/04/1992

    Application Number : 19920424000043

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    15

    Octapharma

    Switzerland
    ISPE Annual Meeting
    Not Confirmed
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    Octapharma

    Switzerland
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    ISPE Annual Meeting
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    Regulatory Info : Schedule D

    Registration Country : Canada

    COAGULATION FACTOR IX (HUMAN)

    Brand Name : OCTAPLEX

    Dosage Form : KIT

    Dosage Strength : 500UNIT/VIAL

    Packaging : 20ML

    Approval Date :

    Application Number : 2294664

    Regulatory Info : Schedule D

    Registration Country : Canada

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    16

    Octapharma

    Switzerland
    ISPE Annual Meeting
    Not Confirmed
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    Octapharma

    Switzerland
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    ISPE Annual Meeting
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    Regulatory Info : Schedule D

    Registration Country : Canada

    COAGULATION FACTOR X (HUMAN)

    Brand Name : OCTAPLEX

    Dosage Form : KIT

    Dosage Strength : 600UNIT/VIAL

    Packaging : 20ML

    Approval Date :

    Application Number : 2294664

    Regulatory Info : Schedule D

    Registration Country : Canada

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    17

    Takeda Pharmaceutical

    Japan
    ISPE Annual Meeting
    Not Confirmed
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    Takeda Pharmaceutical

    Japan
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    ISPE Annual Meeting
    Not Confirmed
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    Regulatory Info : Approved

    Registration Country : Sweden

    Coagulation Factor Ix, Human

    Brand Name : Immunine

    Dosage Form : Injection/Infusion Solution

    Dosage Strength : 1200IU

    Packaging :

    Approval Date : 16/05/2008

    Application Number : 20070719000053

    Regulatory Info : Approved

    Registration Country : Sweden

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    18

    Takeda Pharmaceutical

    Japan
    ISPE Annual Meeting
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    Takeda Pharmaceutical

    Japan
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    Regulatory Info : Approved

    Registration Country : Sweden

    Coagulation Factor Ix, Human

    Brand Name : Immunine

    Dosage Form : Injection/Infusion Solution

    Dosage Strength : 600IU

    Packaging :

    Approval Date : 16/05/2008

    Application Number : 20070719000046

    Regulatory Info : Approved

    Registration Country : Sweden

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    19

    Takeda Pharmaceutical

    Japan
    ISPE Annual Meeting
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    Takeda Pharmaceutical

    Japan
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    ISPE Annual Meeting
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    Regulatory Info : Schedule D

    Registration Country : Canada

    COAGULATION FACTOR IX (HUMAN)

    Brand Name : IMMUNINE VH

    Dosage Form : POWDER FOR SOLUTION

    Dosage Strength : 720UNIT/5ML

    Packaging : 5ML [ VIAL]

    Approval Date :

    Application Number : 2206021

    Regulatory Info : Schedule D

    Registration Country : Canada

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    20

    Sanquin Plasma Products Bv

    Country
    ISPE Annual Meeting
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    Country
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Coagulation Factor Ix, Human

    Brand Name : Nonafact

    Dosage Form : Solution For Infusion

    Dosage Strength : 100IU/ml

    Packaging :

    Approval Date : 03/07/2001

    Application Number : 20010703000010

    Regulatory Info : Deregistered

    Registration Country : Sweden

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