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    Berotralstat

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    01 5BioCryst Pharmaceuticals

    02 1Biocryst Ireland Limited

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    01

    BioCryst Pharmaceuticals

    U.S.A
    CTAD25
    Not Confirmed
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    BioCryst Pharmaceuticals

    U.S.A
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    CTAD25
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : RX

    Registration Country : USA

    BEROTRALSTAT HYDROCHLORIDE

    Brand Name : ORLADEYO

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : EQ 110MG BASE

    Packaging :

    Approval Date : 2020-12-03

    Application Number : 214094

    Regulatory Info : RX

    Registration Country : USA

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    02

    BioCryst Pharmaceuticals

    U.S.A
    CTAD25
    Not Confirmed
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    BioCryst Pharmaceuticals

    U.S.A
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    CTAD25
    Not Confirmed
    • fda
    • EDQM
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    Regulatory Info : RX

    Registration Country : USA

    BEROTRALSTAT HYDROCHLORIDE

    Brand Name : ORLADEYO

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : EQ 150MG BASE

    Packaging :

    Approval Date : 2020-12-03

    Application Number : 214094

    Regulatory Info : RX

    Registration Country : USA

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    03

    BioCryst Pharmaceuticals

    U.S.A
    CTAD25
    Not Confirmed
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    BioCryst Pharmaceuticals

    U.S.A
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    CTAD25
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Berotralstatum

    Brand Name : Orladeyo

    Dosage Form : Hard Capsule

    Dosage Strength : 150mg

    Packaging :

    Approval Date : 07/06/2022

    Application Number : 68464

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    04

    BioCryst Pharmaceuticals

    U.S.A
    CTAD25
    Not Confirmed
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    BioCryst Pharmaceuticals

    U.S.A
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    CTAD25
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    Regulatory Info : Authorized

    Registration Country : Spain

    Berotralstat Dihydrochloride

    Brand Name : Orladeyo

    Dosage Form : Hard Capsule

    Dosage Strength : 150MG

    Packaging :

    Approval Date : 2022-11-30

    Application Number : 1211544001

    Regulatory Info : Authorized

    Registration Country : Spain

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    05

    BioCryst Pharmaceuticals

    U.S.A
    CTAD25
    Not Confirmed
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    BioCryst Pharmaceuticals

    U.S.A
    arrow
    CTAD25
    Not Confirmed
    • fda
    • EDQM
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    Regulatory Info : Prescription

    Registration Country : Canada

    BEROTRALSTAT (BEROTRALSTAT HYDROCHLORIDE)

    Brand Name : ORLADEYO

    Dosage Form : CAPSULE

    Dosage Strength : 150MG

    Packaging :

    Approval Date :

    Application Number : 2527693

    Regulatory Info : Prescription

    Registration Country : Canada

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    06

    Biocryst Ireland Limited

    Country
    CTAD25
    Not Confirmed
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    Biocryst Ireland Limited

    Country
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    CTAD25
    Not Confirmed
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    Regulatory Info : Approved

    Registration Country : Sweden

    Berotralstatdihydroklorid

    Brand Name : Orladeyo

    Dosage Form : Capsule

    Dosage Strength : 150mg

    Packaging :

    Approval Date : 30/04/2021

    Application Number : 20200311000025

    Regulatory Info : Approved

    Registration Country : Sweden

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