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

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    Niraparib

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    01

    GlaxoSmithKline (Ireland) Limited

    United Kingdom
    ISPE Annual Meeting
    Not Confirmed
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    GlaxoSmithKline (Ireland) Limited

    United Kingdom
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    ISPE Annual Meeting
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    Regulatory Info :

    Registration Country : Norway

    Niraparibtosilatmonohydrat

    Brand Name : Zejula

    Dosage Form : Tablet, film-coated

    Dosage Strength : 100 mg

    Packaging : Blisterpakning 56item

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    02

    GlaxoSmithKline (Ireland) Limited

    United Kingdom
    ISPE Annual Meeting
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    GlaxoSmithKline (Ireland) Limited

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    ISPE Annual Meeting
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    Regulatory Info :

    Registration Country : Norway

    Niraparibtosilatmonohydrat

    Brand Name : Zejula

    Dosage Form : Tablet, film-coated

    Dosage Strength : 100 mg

    Packaging : Blisterpakning 84item

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    03

    Glaxosmithkline Ag

    United Kingdom
    ISPE Annual Meeting
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Niraparibum

    Brand Name : Zejula capsules

    Dosage Form : Capsule

    Dosage Strength : 100mg

    Packaging :

    Approval Date : 03/10/2018

    Application Number : 66763

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    04

    Glaxosmithkline Ag

    United Kingdom
    ISPE Annual Meeting
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Niraparibum

    Brand Name : Zejula

    Dosage Form : Film Coated Tablet

    Dosage Strength : 100mg

    Packaging :

    Approval Date : 20/01/2023

    Application Number : 68652

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    05

    Glaxosmithkline (Ireland) Limited

    United Kingdom
    ISPE Annual Meeting
    Not Confirmed
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    Glaxosmithkline (Ireland) Limited

    United Kingdom
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    ISPE Annual Meeting
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    Regulatory Info : Authorized

    Registration Country : Spain

    Niraparib Tosylate Monohydrate

    Brand Name : Zejula

    Dosage Form : Film Coated Tablet

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 2024-04-12

    Application Number : 1171235006

    Regulatory Info : Authorized

    Registration Country : Spain

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    06

    Glaxosmithkline (Ireland) Limited

    United Kingdom
    ISPE Annual Meeting
    Not Confirmed
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    Glaxosmithkline (Ireland) Limited

    United Kingdom
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    ISPE Annual Meeting
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    Regulatory Info : Authorized

    Registration Country : Spain

    Niraparib Tosylate Monohydrate

    Brand Name : Zejula

    Dosage Form : Hard Capsule

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 2018-03-08

    Application Number : 1171235001

    Regulatory Info : Authorized

    Registration Country : Spain

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    07

    Janssen-Cilag Ag

    Italy
    ISPE Annual Meeting
    Not Confirmed
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    Janssen-Cilag Ag

    Italy
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    ISPE Annual Meeting
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Niraparib; Abiraterone Acetate

    Brand Name : Akeega mg

    Dosage Form : Film Coated Tablet

    Dosage Strength : 50mg;500mg

    Packaging :

    Approval Date : 18/04/2024

    Application Number : 68977

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    08

    Janssen-Cilag Ag

    Italy
    ISPE Annual Meeting
    Not Confirmed
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    Janssen-Cilag Ag

    Italy
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    ISPE Annual Meeting
    Not Confirmed
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Niraparib; Abiraterone Acetate

    Brand Name : Akeega mg

    Dosage Form : Film Coated Tablet

    Dosage Strength : 100mg;500mg

    Packaging :

    Approval Date : 18/04/2024

    Application Number : 68977

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    09

    Janssen-Cilag International N.V.

    Italy
    ISPE Annual Meeting
    Not Confirmed
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    Janssen-Cilag International N.V.

    Italy
    arrow
    ISPE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
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    Regulatory Info : Authorized

    Registration Country : Spain

    Abiraterone Acetate; Niraparib Tosylate Monohydrate

    Brand Name : Akeega

    Dosage Form : Film Coated Tablet

    Dosage Strength : 100MG; 500 MG

    Packaging :

    Approval Date : 2023-04-27

    Application Number : 1231722002

    Regulatory Info : Authorized

    Registration Country : Spain

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    10

    Janssen-Cilag International N.V.

    Italy
    ISPE Annual Meeting
    Not Confirmed
    arrow

    Janssen-Cilag International N.V.

    Italy
    arrow
    ISPE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : Authorized

    Registration Country : Spain

    Abiraterone Acetate; Niraparib Tosylate Monohydrate

    Brand Name : Akeega

    Dosage Form : Film Coated Tablet

    Dosage Strength : 50MG; 500 MG

    Packaging :

    Approval Date : 2023-04-27

    Application Number : 1231722001

    Regulatory Info : Authorized

    Registration Country : Spain

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