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    01

    Amgen Inc

    U.S.A
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    CYSTEAMINE BITARTRATE

    Brand Name : PROCYSBI

    Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

    Dosage Strength : EQ 25MG BASE

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    Approval Date : 2013-04-30

    Application Number : 203389

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    Amgen Inc

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    CYSTEAMINE BITARTRATE

    Brand Name : PROCYSBI

    Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

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    Approval Date : 2013-04-30

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    03

    Amgen Inc

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    CYSTEAMINE BITARTRATE

    Brand Name : PROCYSBI

    Dosage Form : GRANULE, DELAYED RELEASE;ORAL

    Dosage Strength : EQ 75MG BASE/PACKET

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    Approval Date : 2020-02-14

    Application Number : 213491

    Regulatory Info : RX

    Registration Country : USA

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    04

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    CYSTEAMINE BITARTRATE

    Brand Name : PROCYSBI

    Dosage Form : GRANULE, DELAYED RELEASE;ORAL

    Dosage Strength : EQ 300MG BASE/PACKET

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    Approval Date : 2020-02-14

    Application Number : 213491

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    05

    Amgen Inc

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    CYSTEAMINE (CYSTEAMINE BITARTRATE)

    Brand Name : PROCYSBI

    Dosage Form : CAPSULE (DELAYED RELEASE)

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    Application Number : 2464705

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    06

    Amgen Inc

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    Regulatory Info : Prescription

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    CYSTEAMINE (CYSTEAMINE BITARTRATE)

    Brand Name : PROCYSBI

    Dosage Form : CAPSULE (DELAYED RELEASE)

    Dosage Strength : 75MG

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    Approval Date :

    Application Number : 2464713

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    07

    Chiesi Group

    Italy
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    Regulatory Info : Allowed

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    Mercaptamin

    Brand Name : Procysbi

    Dosage Form : Gastro-Resistant Capsule

    Dosage Strength : 25mg

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    Approval Date : 16/08/2019

    Application Number : 67129

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    Registration Country : Switzerland

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    08

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    Regulatory Info : Allowed

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    Mercaptamin

    Brand Name : Procysbi

    Dosage Form : Gastro-Resistant Capsule

    Dosage Strength : 75mg

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    Approval Date : 16/08/2019

    Application Number : 67129

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    Registration Country : Switzerland

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    09

    Chiesi Group

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    Regulatory Info : Approved

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    Mercaptamine Bitartrate

    Brand Name : Procysbee

    Dosage Form : Capsule

    Dosage Strength : 25mg

    Packaging :

    Approval Date : 06/09/2013

    Application Number : 20120308000015

    Regulatory Info : Approved

    Registration Country : Sweden

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    10

    Chiesi Group

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    Regulatory Info : Approved

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    Mercaptamine Bitartrate

    Brand Name : Procysbee

    Dosage Form : Capsule

    Dosage Strength : 75mg

    Packaging :

    Approval Date : 06/09/2013

    Application Number : 20120308000022

    Regulatory Info : Approved

    Registration Country : Sweden

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    11

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    Regulatory Info : Approved

    Registration Country : Sweden

    Mercaptamine Bitartrate

    Brand Name : Procysbi

    Dosage Form : Granules

    Dosage Strength : 300mg

    Packaging :

    Approval Date : 17/08/2022

    Application Number : 20210624000032

    Regulatory Info : Approved

    Registration Country : Sweden

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    12

    Chiesi Group

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    Regulatory Info : Approved

    Registration Country : Sweden

    Mercaptamine Bitartrate

    Brand Name : Procysbi

    Dosage Form : Granules

    Dosage Strength : 75mg

    Packaging :

    Approval Date : 17/08/2022

    Application Number : 20210624000025

    Regulatory Info : Approved

    Registration Country : Sweden

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    13

    ORPHAN EUROPE SARL

    France
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    ORPHAN EUROPE SARL

    France
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    Registration Country : Italy

    Cysteamine Bitartrate

    Brand Name : Cystagon

    Dosage Form : Mercaptamine 50Mg 100 Unita' Oral Use

    Dosage Strength : 100 cps 50 mg

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    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    14

    ORPHAN EUROPE SARL

    France
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    Regulatory Info :

    Registration Country : Italy

    Cysteamine Bitartrate

    Brand Name : Cystagon

    Dosage Form : Mercaptamine 150Mg 100 Unita' Oral Use

    Dosage Strength : 100 cps 150 mg

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    Registration Country : Italy

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    15

    Recordati

    Italy
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Mercaptamin

    Brand Name : Cystadrops

    Dosage Form : Eye Drop

    Dosage Strength : 3.8mg/ml

    Packaging :

    Approval Date : 24/09/2020

    Application Number : 67380

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    16

    Recordati Rare Diseases

    U.S.A
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    Regulatory Info : Approved

    Registration Country : Sweden

    Mercaptamine Bitartrate

    Brand Name : Cystagon

    Dosage Form : Capsule

    Dosage Strength : 150mg

    Packaging :

    Approval Date : 23/06/1997

    Application Number : 19970623000023

    Regulatory Info : Approved

    Registration Country : Sweden

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    17

    Recordati Rare Diseases

    U.S.A
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    Regulatory Info : Approved

    Registration Country : Sweden

    Mercaptamine Bitartrate

    Brand Name : Cystagon

    Dosage Form : Capsule

    Dosage Strength : 50mg

    Packaging :

    Approval Date : 23/06/1997

    Application Number : 19970623000016

    Regulatory Info : Approved

    Registration Country : Sweden

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    18

    Recordati Rare Diseases

    U.S.A
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    Regulatory Info : Marketed

    Registration Country : Norway

    Mercaptamine bitartrate

    Brand Name : Cystagon

    Dosage Form : Capsule

    Dosage Strength : 150mg

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    Approval Date :

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    Regulatory Info : Marketed

    Registration Country : Norway

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    19

    Viatris

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    CYSTEAMINE BITARTRATE

    Brand Name : CYSTAGON

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : EQ 50MG BASE

    Packaging :

    Approval Date : 1994-08-15

    Application Number : 20392

    Regulatory Info : RX

    Registration Country : USA

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    Viatris

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    CYSTEAMINE BITARTRATE

    Brand Name : CYSTAGON

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : EQ 150MG BASE

    Packaging :

    Approval Date : 1994-08-15

    Application Number : 20392

    Regulatory Info : RX

    Registration Country : USA

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