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    Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

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    Kikkoman Biochemifa Company advances global health and safety through precision-driven innovation in biotech and food testing.

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    Hepatitis B Immune Globulin

    FINISHED DOSAGE FORMULATIONS

    GLOBAL SALES INFORMATION

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    01 2Glaxosmithkline Biologicals

    02 4Glaxosmithkline Sa

    03 6Merck Sharp & Dohme Bv

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    01

    Glaxosmithkline Biologicals

    United Kingdom
    ISPE Annual Meeting
    Not Confirmed
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    Glaxosmithkline Biologicals

    United Kingdom
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    ISPE Annual Meeting
    Not Confirmed
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    Regulatory Info : Authorized

    Registration Country : Spain

    Hepatitis B Surface Antigen

    Brand Name : Fendrix, Injectable Suspension

    Dosage Form : Injectable Suspension

    Dosage Strength :

    Packaging :

    Approval Date : 2005-02-23

    Application Number : 04299003

    Regulatory Info : Authorized

    Registration Country : Spain

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    02

    Glaxosmithkline Sa

    United Kingdom
    ISPE Annual Meeting
    Not Confirmed
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    Glaxosmithkline Sa

    United Kingdom
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    ISPE Annual Meeting
    Not Confirmed
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    Regulatory Info : Cancelled

    Registration Country : Spain

    Hepatitis B Surface Antigen

    Brand Name : Engerix- B Junior

    Dosage Form : Injectable Suspension

    Dosage Strength : 10MCG

    Packaging :

    Approval Date : 1990-06-01

    Application Number : 58866

    Regulatory Info : Cancelled

    Registration Country : Spain

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    03

    Glaxosmithkline Sa

    United Kingdom
    ISPE Annual Meeting
    Not Confirmed
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    Glaxosmithkline Sa

    United Kingdom
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    ISPE Annual Meeting
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    Regulatory Info : Cancelled

    Registration Country : Spain

    Hepatitis B Surface Antigen

    Brand Name : Engerix- B

    Dosage Form : Injectable Suspension

    Dosage Strength : 20MCG

    Packaging :

    Approval Date : 1987-10-01

    Application Number : 57513

    Regulatory Info : Cancelled

    Registration Country : Spain

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    04

    Glaxosmithkline Sa

    United Kingdom
    ISPE Annual Meeting
    Not Confirmed
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    Glaxosmithkline Sa

    United Kingdom
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    ISPE Annual Meeting
    Not Confirmed
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    Regulatory Info : Authorized

    Registration Country : Spain

    Hepatitis B Surface Antigen

    Brand Name : Engerix- B

    Dosage Form : Injectable Suspension In Pre-Filled Syringe

    Dosage Strength : 20MCG

    Packaging :

    Approval Date : 1995-11-01

    Application Number : 60653

    Regulatory Info : Authorized

    Registration Country : Spain

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    05

    Glaxosmithkline Sa

    United Kingdom
    ISPE Annual Meeting
    Not Confirmed
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    Glaxosmithkline Sa

    United Kingdom
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    ISPE Annual Meeting
    Not Confirmed
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    Regulatory Info : Authorized

    Registration Country : Spain

    Hepatitis B Surface Antigen

    Brand Name : Engerix- B Junior

    Dosage Form : Injectable Suspension In Pre-Filled Syringe

    Dosage Strength : 10MCG

    Packaging :

    Approval Date : 1995-11-01

    Application Number : 60652

    Regulatory Info : Authorized

    Registration Country : Spain

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    06

    Merck Sharp & Dohme Bv

    U.S.A
    ISPE Annual Meeting
    Not Confirmed
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    Merck Sharp & Dohme Bv

    U.S.A
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    ISPE Annual Meeting
    Not Confirmed
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    Regulatory Info : Authorized

    Registration Country : Spain

    Hepatitis B Surface Antigen

    Brand Name : Hbvaxpro

    Dosage Form : Injectable Suspension

    Dosage Strength : 10MCG

    Packaging :

    Approval Date : 2001-05-22

    Application Number : 01183007

    Regulatory Info : Authorized

    Registration Country : Spain

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    07

    Merck Sharp & Dohme Bv

    U.S.A
    ISPE Annual Meeting
    Not Confirmed
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    Merck Sharp & Dohme Bv

    U.S.A
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    ISPE Annual Meeting
    Not Confirmed
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    Regulatory Info : Authorized

    Registration Country : Spain

    Hepatitis B Surface Antigen

    Brand Name : Hbvaxpro

    Dosage Form : Injectable Suspension

    Dosage Strength : 5MCG

    Packaging :

    Approval Date : 2001-12-12

    Application Number : 01183018

    Regulatory Info : Authorized

    Registration Country : Spain

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    08

    Merck Sharp & Dohme Bv

    U.S.A
    ISPE Annual Meeting
    Not Confirmed
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    Merck Sharp & Dohme Bv

    U.S.A
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    ISPE Annual Meeting
    Not Confirmed
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    Regulatory Info : Authorized

    Registration Country : Spain

    Hepatitis B Surface Antigen

    Brand Name : Hbvaxpro

    Dosage Form : Injectable Suspension

    Dosage Strength : 40MCG

    Packaging :

    Approval Date : 2001-05-22

    Application Number : 01183015

    Regulatory Info : Authorized

    Registration Country : Spain

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    09

    Merck Sharp & Dohme Bv

    U.S.A
    ISPE Annual Meeting
    Not Confirmed
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    Merck Sharp & Dohme Bv

    U.S.A
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    ISPE Annual Meeting
    Not Confirmed
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    Regulatory Info : Authorized

    Registration Country : Spain

    Hepatitis B Surface Antigen

    Brand Name : Hbvaxpro

    Dosage Form : Injectable Suspension In Pre-Filled Syringe

    Dosage Strength : 10MCG

    Packaging :

    Approval Date : 2005-09-22

    Application Number : 01183028

    Regulatory Info : Authorized

    Registration Country : Spain

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    10

    Merck Sharp & Dohme Bv

    U.S.A
    ISPE Annual Meeting
    Not Confirmed
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    Merck Sharp & Dohme Bv

    U.S.A
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    ISPE Annual Meeting
    Not Confirmed
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    • EDQM
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    Virtual Booth Virtual Booth
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    Regulatory Info : Authorized

    Registration Country : Spain

    Hepatitis B Surface Antigen

    Brand Name : Hbvaxpro

    Dosage Form : Injectable Suspension In Pre-Filled Syringe

    Dosage Strength : 5MCG

    Packaging :

    Approval Date : 2005-09-22

    Application Number : 01183024

    Regulatory Info : Authorized

    Registration Country : Spain

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