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01 6Amgen Inc

02 4CHIESI USA INC

03 12Chiesi Group

04 2Chiesi Orphan Bv

05 2ORPHAN EUROPE SARL

06 1Recordati

07 11Recordati Rare Diseases

08 2Viatris

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PharmaCompass

01

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

CYSTEAMINE BITARTRATE

Brand Name : PROCYSBI

Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

Dosage Strength : EQ 25MG BASE

Packaging :

Approval Date : 2013-04-30

Application Number : 203389

Regulatory Info : RX

Registration Country : USA

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02

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

CYSTEAMINE BITARTRATE

Brand Name : PROCYSBI

Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

Dosage Strength : EQ 75MG BASE

Packaging :

Approval Date : 2013-04-30

Application Number : 203389

Regulatory Info : RX

Registration Country : USA

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03

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

CYSTEAMINE BITARTRATE

Brand Name : PROCYSBI

Dosage Form : GRANULE, DELAYED RELEASE;ORAL

Dosage Strength : EQ 75MG BASE/PACKET

Packaging :

Approval Date : 2020-02-14

Application Number : 213491

Regulatory Info : RX

Registration Country : USA

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04

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

CYSTEAMINE BITARTRATE

Brand Name : PROCYSBI

Dosage Form : GRANULE, DELAYED RELEASE;ORAL

Dosage Strength : EQ 300MG BASE/PACKET

Packaging :

Approval Date : 2020-02-14

Application Number : 213491

Regulatory Info : RX

Registration Country : USA

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05

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

Mercaptamin

Brand Name : Procysbi

Dosage Form : Gastro-Resistant Capsule

Dosage Strength : 25mg

Packaging :

Approval Date : 16/08/2019

Application Number : 67129

Regulatory Info : Allowed

Registration Country : Switzerland

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06

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

Mercaptamin

Brand Name : Procysbi

Dosage Form : Gastro-Resistant Capsule

Dosage Strength : 75mg

Packaging :

Approval Date : 16/08/2019

Application Number : 67129

Regulatory Info : Allowed

Registration Country : Switzerland

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07

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

Mercaptamine bitartrate

Brand Name : Procysbi

Dosage Form : Enteric-Coated Capsule

Dosage Strength : 25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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08

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

Mercaptamine bitartrate

Brand Name : Procysbi

Dosage Form : Enteric-Coated Capsule

Dosage Strength : 75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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09

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

Mercaptamine

Brand Name : Procysbi

Dosage Form : Gastro Resistant Capsule

Dosage Strength : 25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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10

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

Mercaptamine

Brand Name : Procysbi

Dosage Form : Gastro Resistant Granule

Dosage Strength : 300mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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11

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

Cysteamine Bitartrate

Brand Name : Cystagon

Dosage Form : Mercaptamine 50Mg 100 Unita' Oral Use

Dosage Strength : 100 cps 50 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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12

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

Cysteamine Bitartrate

Brand Name : Cystagon

Dosage Form : Mercaptamine 150Mg 100 Unita' Oral Use

Dosage Strength : 100 cps 150 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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13

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

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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14

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

Mercaptamine bitartrate

Brand Name : Cystagon

Dosage Form : Capsule

Dosage Strength : 150mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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15

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

Mercaptamine bitartrate

Brand Name : Cystagon

Dosage Form : Capsule

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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16

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

Mercaptamine

Brand Name : Cystagon

Dosage Form : Capsule

Dosage Strength : 150mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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17

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

Mercaptamine

Brand Name : Cystadrops

Dosage Form : Ophthalmic Solution

Dosage Strength : 38mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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18

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

Mercaptamine

Brand Name : Cystagon

Dosage Form : Capsule

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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19

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

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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20

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

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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