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01 2Sanofi Bv

02 1Shire Human Genetic Therapies Ab

03 1Takeda Pharma Ag

04 2Takeda Pharmaceuticals International Ag Ireland Branch

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Authorized

Registration Country : Spain

Agalsidase Beta

Brand Name : Fabrazyme

Dosage Form : Powder For Concentrate For Infusion Solution

Dosage Strength : 5MG

Packaging :

Approval Date : 2004-01-13

Application Number : 01188004

Regulatory Info : Authorized

Registration Country : Spain

Sanofi Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Authorized

Registration Country : Spain

Agalsidase Beta

Brand Name : Fabrazyme

Dosage Form : Powder For Concentrate For Infusion Solution

Dosage Strength : 35MG

Packaging :

Approval Date : 2001-08-31

Application Number : 01188001

Regulatory Info : Authorized

Registration Country : Spain

Sanofi Company Banner

03

OTS 2025
Not Confirmed
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OTS 2025
Not Confirmed

Agalsidase Alpha

Brand Name : Replagal

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 1MG

Packaging :

Approval Date : 2005-05-20

Application Number : 01189004

Regulatory Info : Authorized

Registration Country : Spain

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04

OTS 2025
Not Confirmed
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OTS 2025
Not Confirmed

Agalsidase Alfa

Brand Name : Replagal

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 2001-08-03

Application Number : 20010803000019

Regulatory Info : Approved

Registration Country : Sweden

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05

OTS 2025
Not Confirmed
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OTS 2025
Not Confirmed

Agalsidase Alfa

Brand Name : Replagal Durchstechflasche

Dosage Form : Infusion Concentrate

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 28/12/2001

Application Number : 55774

Regulatory Info : Allowed

Registration Country : Switzerland

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06

OTS 2025
Not Confirmed
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OTS 2025
Not Confirmed

Agalsidase Alpha

Brand Name : Replagal

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 1MG

Packaging :

Approval Date : 2002-02-11

Application Number : 01189001

Regulatory Info : Authorized

Registration Country : Spain

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