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01 1AUROBINDO PHARMA ITALIA SRL

02 1Aurobindo Pharma (Malta) Limited

03 1Aurovitas Spain, Sau

04 2BIOMARIN INTERNATIONAL LIMITED

05 2BioMarin International Limited

06 4Biomarin International Limited

07 3DIPHARMA ARZNEIMITTEL GMBH

08 4Dipharma Arzneimittel GmbH

09 6Dipharma Arzneimittel Gmbh

10 3Dipharma Sa

11 1Drac Ag

12 1Nobel Pharma Schweiz Ag

13 1PIAM FARMACEUTICI SPA

14 1Spirig Healthcare Ag

15 1Stada Pharmaceuticals Ag

16 1Stada Sl Laboratory

17 1Tarbis Farma Sl

18 1Teva GmbH

19 1Teva Gmbh

20 1Teva Pharma Slu

21 2Blank

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PharmaCompass

01

VMX
Not Confirmed
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Sapropterin

Brand Name : SAPROPTERINA AUROBINDO

Dosage Form : Soluble Tablets

Dosage Strength : 100 mg

Packaging : 120 UNITS 100 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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02

VMX
Not Confirmed
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VMX
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Sapropterin

Brand Name : KUVAN

Dosage Form : Soluble Tablets

Dosage Strength : 100mg

Packaging : 120 UNITS 100 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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03

VMX
Not Confirmed
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VMX
Not Confirmed

Sapropterin

Brand Name : KUVAN

Dosage Form : Soluble Tablets

Dosage Strength : 100mg

Packaging : 30 UNITS 100 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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04

VMX
Not Confirmed
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VMX
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Sapropterin

Brand Name : SAPROPTERIN DIPHARMA

Dosage Form : Powder For Oral Solution Oral

Dosage Strength : 100 mg

Packaging : 30 UNITS 100 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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05

VMX
Not Confirmed
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VMX
Not Confirmed

Sapropterin

Brand Name : SAPROPTERIN DIPHARMA

Dosage Form : Soluble Tablets

Dosage Strength : 100mg

Packaging : 120 UNITS 100 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

VMX
Not Confirmed
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VMX
Not Confirmed

Sapropterin

Brand Name : SAPROPTERIN DIPHARMA

Dosage Form : Soluble Tablets

Dosage Strength : 100mg

Packaging : 30 UNITS 100 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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07

VMX
Not Confirmed
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VMX
Not Confirmed

Sapropterin

Brand Name : Sapropterin Dipharma

Dosage Form : Powder For Oral Solution

Dosage Strength : 100mg

Packaging :

Approval Date : 14/12/2021

Application Number : 67735

Regulatory Info : Allowed

Registration Country : Switzerland

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08

VMX
Not Confirmed
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VMX
Not Confirmed

Sapropterin

Brand Name : ARPETRAN

Dosage Form : Soluble Tablets

Dosage Strength : 100 mg

Packaging : 120 UNITS 100 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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09

Country
VMX
Not Confirmed
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VMX
Not Confirmed

Tetrahydrobiopterin

Brand Name : Kuvan

Dosage Form : Sapropterina 100Mg 120 Unita' Oral Use

Dosage Strength : 120 cpr solub 100 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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10

Country
VMX
Not Confirmed
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Country
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VMX
Not Confirmed

Tetrahydrobiopterin

Brand Name : Kuvan

Dosage Form : Sapropterina 100Mg 30 Joined' Oral Use

Dosage Strength : 30 cpr solub 100 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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