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01 1AUROBINDO PHARMA ITALIA SRL

02 1Aurovitas Spain, Sau

03 2BIOMARIN INTERNATIONAL LIMITED

04 2BioMarin International Limited

05 7Biomarin International Limited

06 3DIPHARMA ARZNEIMITTEL GMBH

07 4Dipharma Arzneimittel GmbH

08 9Dipharma Arzneimittel Gmbh

09 3Dipharma Sa

10 1Drac Ag

11 1Nobel Pharma Schweiz Ag

12 1PIAM FARMACEUTICI SPA

13 1Sandoz A/S

14 1Spirig Healthcare Ag

15 1Stada Pharmaceuticals Ag

16 1Stada Sl Laboratory

17 1Tarbis Farma Sl

18 1Teva GmbH

19 1Teva Pharma Slu

20 2Blank

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PharmaCompass

01

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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

ASPEN
Not Confirmed
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ASPEN
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

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Sapropterin dihydrochloride

Brand Name : Kuvan

Dosage Form : Orodispersible Tablet

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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05

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Sapropterin dihydrochloride

Brand Name : Kuvan

Dosage Form : Orodispersible Tablet

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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06

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Sapropterin

Brand Name : Kuvan

Dosage Form : Orodispersible Tablet

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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07

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Sapropterin

Brand Name : Kuvan

Dosage Form : Powder For Oral Solution

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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08

Country
ASPEN
Not Confirmed
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ASPEN
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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09

Country
ASPEN
Not Confirmed
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ASPEN
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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10

Aurovitas Spain, Sau

Country
ASPEN
Not Confirmed
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Aurovitas Spain, Sau

Country
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ASPEN
Not Confirmed

Sapropterin Hydrochloride

Brand Name : Sapropterina Aurovitas

Dosage Form : Soluble Tablet

Dosage Strength : 100MG

Packaging :

Approval Date : 23-03-2023

Application Number : 88742

Regulatory Info : Authorized

Registration Country : Spain

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