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01 4Chiesi Group

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PharmaCompass

01

AAPS
Not Confirmed
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AAPS
Not Confirmed

PEGUNIGALSIDASE ALFA-IWXJ

Brand Name : ELFABRIO

Dosage Form : VIAL; SINGLE-USE

Dosage Strength : 20MG/10ML

Packaging :

Approval Date :

Application Number : 761161

Regulatory Info :

Registration Country : USA

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02

AAPS
Not Confirmed
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AAPS
Not Confirmed

Pegunigalsidas Alfa

Brand Name : Elfabrio

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 2mg/ml

Packaging :

Approval Date : 04/05/2023

Application Number : 20220126000010

Regulatory Info : Approved

Registration Country : Sweden

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03

AAPS
Not Confirmed
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AAPS
Not Confirmed

Pegunigalsidase Alpha

Brand Name : Elfabrio

Dosage Form : Solution For Injection

Dosage Strength : 20mg/10ml

Packaging :

Approval Date : 11/09/2023

Application Number : 69257

Regulatory Info : Allowed

Registration Country : Switzerland

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04

AAPS
Not Confirmed
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AAPS
Not Confirmed

Pegunigalsidase Alpha

Brand Name : Factory

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 2MG

Packaging :

Approval Date : 2023-07-28

Application Number : 1231724002

Regulatory Info : Authorized

Registration Country : Spain

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