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01 1AUROBINDO PHARMA ITALIA SRL

02 2BIOMARIN INTERNATIONAL LIMITED

03 2BioMarin International Limited

04 3DIPHARMA ARZNEIMITTEL GMBH

05 4Dipharma Arzneimittel GmbH

06 4Dipharma SA

07 1Orifarm AS

08 1PIAM FARMACEUTICI SPA

09 2Blank

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PharmaCompass

01

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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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

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
Not Confirmed

sapropterin dihydrochloride

Brand Name : Kuvan

Dosage Form : SOLUBLE TABLET

Dosage Strength : 100 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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03

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
Not Confirmed

Sapropterin Dihydrochloride

Brand Name : Kuvan

Dosage Form : Soluble Antic-Calc tablet

Dosage Strength : 100 mg

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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04

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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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05

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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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06

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
Not Confirmed

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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07

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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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08

2024 ACI Convention
Not Confirmed
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arrow
2024 ACI Convention
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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09

Country
2024 ACI Convention
Not Confirmed
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Country
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2024 ACI Convention
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
2024 ACI Convention
Not Confirmed
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Country
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2024 ACI Convention
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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