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01 1AMICUS THERAPEUTICS CANADA INC.

02 1AMICUS THERAPEUTICS PTY LTD

03 4Amicus Therapeutics

04 1Biomed

05 3Curatis

06 4Nobel Pharma Schweiz Ag

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PharmaCompass

01

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MIGALASTAT HYDROCHLORIDE

Brand Name : GALAFOLD

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 123MG BASE

Packaging :

Approval Date : 2018-08-10

Application Number : 208623

Regulatory Info : RX

Registration Country : USA

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02

PREP
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Migalastat Hydrochloride

Brand Name : Galafold

Dosage Form : Capsule

Dosage Strength : 123mg

Packaging :

Approval Date : 26/05/2016

Application Number : 20150626000015

Regulatory Info : Approved

Registration Country : Sweden

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03

PREP
Not Confirmed
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Migalastatum

Brand Name : Galafold

Dosage Form : Capsule

Dosage Strength : 123mg

Packaging :

Approval Date : 28/10/2016

Application Number : 66108

Regulatory Info : Allowed

Registration Country : Switzerland

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04

PREP
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PREP
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Migalastat Hydrochloride

Brand Name : Galafold

Dosage Form : Hard Capsule

Dosage Strength : 123MG

Packaging :

Approval Date : 2016-08-29

Application Number : 1151082001

Regulatory Info : Authorized

Registration Country : Spain

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05

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Chlorophyllin|Cupric And Sodium

Brand Name : Leaf Green Dragees

Dosage Form : Tablet

Dosage Strength :

Packaging :

Approval Date : 11/10/1962

Application Number : 26293

Regulatory Info : Allowed

Registration Country : Switzerland

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06

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Of The Race

Brand Name : Nityr

Dosage Form : Tablet

Dosage Strength : 2mg

Packaging :

Approval Date : 24/01/2022

Application Number : 67970

Regulatory Info : Allowed

Registration Country : Switzerland

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07

PREP
Not Confirmed
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Of The Race

Brand Name : Nityr

Dosage Form : Tablet

Dosage Strength : 5mg

Packaging :

Approval Date : 24/01/2022

Application Number : 67970

Regulatory Info : Allowed

Registration Country : Switzerland

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08

PREP
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Of The Race

Brand Name : Nityr

Dosage Form : Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 24/01/2022

Application Number : 67970

Regulatory Info : Allowed

Registration Country : Switzerland

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09

Nobel Pharma Schweiz Ag

Country
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Not Confirmed
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Nobel Pharma Schweiz Ag

Country
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Of The Race

Brand Name : Nitisinone NOBEL

Dosage Form : Hard Capsule

Dosage Strength : 5mg

Packaging :

Approval Date : 01/06/2022

Application Number : 68331

Regulatory Info : Allowed

Registration Country : Switzerland

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10

Nobel Pharma Schweiz Ag

Country
PREP
Not Confirmed
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Nobel Pharma Schweiz Ag

Country
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PREP
Not Confirmed

Of The Race

Brand Name : Nitisinone NOBEL

Dosage Form : Hard Capsule

Dosage Strength : 10mg

Packaging :

Approval Date : 01/06/2022

Application Number : 68331

Regulatory Info : Allowed

Registration Country : Switzerland

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11

Nobel Pharma Schweiz Ag

Country
PREP
Not Confirmed
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Nobel Pharma Schweiz Ag

Country
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PREP
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Of The Race

Brand Name : Nitisinone NOBEL

Dosage Form : Hard Capsule

Dosage Strength : 20mg

Packaging :

Approval Date : 01/06/2022

Application Number : 68331

Regulatory Info : Allowed

Registration Country : Switzerland

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12

Nobel Pharma Schweiz Ag

Country
PREP
Not Confirmed
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Nobel Pharma Schweiz Ag

Country
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PREP
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Of The Race

Brand Name : Nitisinone NOBEL

Dosage Form : Suspension

Dosage Strength : 4mg/ml

Packaging :

Approval Date : 01/06/2022

Application Number : 68332

Regulatory Info : Allowed

Registration Country : Switzerland

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13

AMICUS THERAPEUTICS CANADA INC.

Country
PREP
Not Confirmed
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AMICUS THERAPEUTICS CANADA INC.

Country
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PREP
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MIGALASTAT (MIGALASTAT HYDROCHLORIDE)

Brand Name : GALAFOLD

Dosage Form : CAPSULE

Dosage Strength : 123MG

Packaging : 14

Approval Date :

Application Number : 2468042

Regulatory Info : Prescription

Registration Country : Canada

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14

AMICUS THERAPEUTICS PTY LTD

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Not Confirmed
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AMICUS THERAPEUTICS PTY LTD

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PREP
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Migalastat

Brand Name : Galafold

Dosage Form :

Dosage Strength :

Packaging : 14

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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