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

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    Hepatitis B Immune Globulin

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    03 2Grifols International

    04 1KI Biopharma

    05 6Merck & Co

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    01

    Biomed Lublin

    Poland
    ISPE Annual Meeting
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    Biomed Lublin

    Poland
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    Regulatory Info :

    Registration Country : Poland

    Hepatitis B Immune Globulin

    Brand Name : GAMMA anty-HBs 200

    Dosage Form : Solution for Injection

    Dosage Strength : 200IU

    Packaging : 1 ampoule 1.0 ml cardboard box

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Poland

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    02

    Biomed Lublin

    Poland
    ISPE Annual Meeting
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    Poland
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    Regulatory Info :

    Registration Country : Poland

    Hepatitis B Immune Globulin

    Brand Name : GAMMA anty-HBs 1000

    Dosage Form : Solution for Injection

    Dosage Strength : 1000IU

    Packaging : 1 ampoule 1.5 ml cardboard box

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Poland

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    03

    Grifols International

    Spain
    ISPE Annual Meeting
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    Grifols International

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    Regulatory Info : Schedule D

    Registration Country : Canada

    HEPATITIS B IMMUNOGLOBULIN (HUMAN)

    Brand Name : HYPERHEP B

    Dosage Form : SOLUTION

    Dosage Strength : 220UNIT/ML

    Packaging :

    Approval Date :

    Application Number : 2520001

    Regulatory Info : Schedule D

    Registration Country : Canada

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    04

    Grifols International

    Spain
    ISPE Annual Meeting
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    Grifols International

    Spain
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    Regulatory Info : Schedule D

    Registration Country : Canada

    HEPATITIS B IMMUNOGLOBULIN (HUMAN)

    Brand Name : HYPERHEP B

    Dosage Form : SOLUTION

    Dosage Strength : 110UNIT/0.5ML

    Packaging :

    Approval Date :

    Application Number : 2520125

    Regulatory Info : Schedule D

    Registration Country : Canada

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    05

    GSK

    United Kingdom
    ISPE Annual Meeting
    Not Confirmed
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    GSK

    United Kingdom
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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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    06

    GSK

    United Kingdom
    ISPE Annual Meeting
    Not Confirmed
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    GSK

    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 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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    07

    GSK

    United Kingdom
    ISPE Annual Meeting
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    GSK

    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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    08

    GSK

    United Kingdom
    ISPE Annual Meeting
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    GSK

    United Kingdom
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    ISPE Annual Meeting
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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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    09

    GSK

    United Kingdom
    ISPE Annual Meeting
    Not Confirmed
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    GSK

    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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    10

    GSK

    United Kingdom
    ISPE Annual Meeting
    Not Confirmed
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    GSK

    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 : 04299001

    Regulatory Info : Authorized

    Registration Country : Spain

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    11

    KI Biopharma

    U.S.A
    ISPE Annual Meeting
    Not Confirmed
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    KI Biopharma

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

    Registration Country : Canada

    HEPATITIS B IMMUNOGLOBULIN (HUMAN)

    Brand Name : HEPAGAM B

    Dosage Form : SOLUTION

    Dosage Strength : 312UNIT/ML

    Packaging :

    Approval Date :

    Application Number : 2290979

    Regulatory Info : Schedule D

    Registration Country : Canada

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    12

    Merck & Co

    U.S.A
    ISPE Annual Meeting
    Not Confirmed
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    Merck & Co

    U.S.A
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    ISPE Annual Meeting
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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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    13

    Merck & Co

    U.S.A
    ISPE Annual Meeting
    Not Confirmed
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    Merck & Co

    U.S.A
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    ISPE Annual Meeting
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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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    14

    Merck & Co

    U.S.A
    ISPE Annual Meeting
    Not Confirmed
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    Merck & Co

    U.S.A
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    ISPE Annual Meeting
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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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    15

    Merck & Co

    U.S.A
    ISPE Annual Meeting
    Not Confirmed
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    Merck & Co

    U.S.A
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    ISPE Annual Meeting
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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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    16

    Merck & Co

    U.S.A
    ISPE Annual Meeting
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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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    17

    Merck & Co

    U.S.A
    ISPE Annual Meeting
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    Merck & Co

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    ISPE Annual Meeting
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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 : 2001-01-22

    Application Number : 01183001

    Regulatory Info : Authorized

    Registration Country : Spain

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