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    01

    Abacus Medicine

    Denmark
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    Pitolisant hydrochloride

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    Pitolisant hydrochloride

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    PITOLISANT

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    Bioprojet Pharma

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    Pitolisant

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    Pitolisant

    Brand Name : Wakix

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    Bioprojet Pharma

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    Pitolisant

    Brand Name : Ozawade

    Dosage Form : Film-Coated Tablet

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    09

    Bioprojet Pharma

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    Regulatory Info : Prescription

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    Pitolisant

    Brand Name : Wakix

    Dosage Form : Film-Coated Tablet

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    Approval Date :

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    Regulatory Info : Prescription

    Registration Country : Estonia

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    10

    Bioprojet Pharma

    France
    PEGS Boston Summit
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    Bioprojet Pharma

    France
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    Regulatory Info : Authorized

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    Pitolisant Hydrochloride

    Brand Name : Ozawade

    Dosage Form : Film Coated Tablet

    Dosage Strength : 4.5MG

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    Approval Date : 11-11-2021

    Application Number : 1211546001

    Regulatory Info : Authorized

    Registration Country : Spain

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    11

    Bioprojet Pharma

    France
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    France
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    Regulatory Info : Authorized

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    Pitolisant Hydrochloride

    Brand Name : Ozawade

    Dosage Form : Film Coated Tablet

    Dosage Strength : 18MG

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    Approval Date : 11-11-2021

    Application Number : 1211546002

    Regulatory Info : Authorized

    Registration Country : Spain

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    12

    Bioprojet Pharma

    France
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    Pitolisant

    Brand Name : Wakix

    Dosage Form : Film Coated Tablet

    Dosage Strength : 4.5MG

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    Approval Date : 03-09-2016

    Application Number : 1151068001

    Regulatory Info : Authorized

    Registration Country : Spain

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    13

    Bioprojet Pharma

    France
    PEGS Boston Summit
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    France
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    Regulatory Info : Authorized

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    Pitolisant

    Brand Name : Wakix

    Dosage Form : Film Coated Tablet

    Dosage Strength : 18MG

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    Approval Date : 03-08-2016

    Application Number : 1151068002

    Regulatory Info : Authorized

    Registration Country : Spain

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    14

    Harmony Biosciences

    U.S.A
    PEGS Boston Summit
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    Regulatory Info : RX

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    PITOLISANT HYDROCHLORIDE

    Brand Name : WAKIX

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 4.45MG BASE

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    Approval Date : 2019-08-14

    Application Number : 211150

    Regulatory Info : RX

    Registration Country : USA

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    15

    Harmony Biosciences

    U.S.A
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    Regulatory Info : RX

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    PITOLISANT HYDROCHLORIDE

    Brand Name : WAKIX

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 17.8MG BASE

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    Approval Date : 2019-08-14

    Application Number : 211150

    Regulatory Info : RX

    Registration Country : USA

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    16

    Lupin Ltd

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    PITOLISANT

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    Application Number : 218846

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    17

    MSN Laboratories

    India
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    PITOLISANT

    Brand Name : PITOLISANT

    Dosage Form : TABLET; FILM COATED

    Dosage Strength : 4.45MG

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    Application Number : 218873

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    Registration Country : USA

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    18

    Novitium Pharma LLC

    U.S.A
    PEGS Boston Summit
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    PITOLISANT

    Brand Name : PITOLISANT

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    Application Number : 218495

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    Registration Country : USA

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    19

    Future Health Pharma Gmbh

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    Pitolisant

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    Dosage Form : Film Coated Tablet

    Dosage Strength : 4.45mg

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    Approval Date : 20/12/2018

    Application Number : 67007

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Future Health Pharma Gmbh

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    Approval Date : 20/12/2018

    Application Number : 67007

    Regulatory Info : Allowed

    Registration Country : Switzerland

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