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01 4Sanofi Bv

02 1Orifarm AS

03 1Shire Human Genetic Therapies Ab

04 1Takeda Pharma Ag

05 3Takeda Pharmaceuticals International AG Ireland Branch

06 4Takeda 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 : 13-01-2004

Application Number : 1188004

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 : 31-08-2001

Application Number : 1188001

Regulatory Info : Authorized

Registration Country : Spain

Sanofi Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : Prescription

Registration Country : Denmark

Agalsidase Beta

Brand Name : Fabrazyme

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 35mg

Packaging :

Approval Date : 03-08-2001

Application Number : 28103161500

Regulatory Info : Prescription

Registration Country : Denmark

Sanofi Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : Prescription

Registration Country : Denmark

Agalsidase Beta

Brand Name : Fabrazyme

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 5mg

Packaging :

Approval Date : 02-12-2002

Application Number : 28103735602

Regulatory Info : Prescription

Registration Country : Denmark

Sanofi Company Banner

05

World Health Expo
Not Confirmed
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World Health Expo
Not Confirmed

Agalsidase alfa

Brand Name : Replagal

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 1mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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06

World Health Expo
Not Confirmed
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World Health Expo
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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07

World Health Expo
Not Confirmed
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World Health Expo
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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08

World Health Expo
Not Confirmed
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World Health Expo
Not Confirmed

Agalsidase alfa

Brand Name : Replagal

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 1mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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09

World Health Expo
Not Confirmed
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World Health Expo
Not Confirmed

Agalsidase alfa

Brand Name : Replagal

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 1mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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10

World Health Expo
Not Confirmed
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arrow
World Health Expo
Not Confirmed

Agalsidase alfa

Brand Name : Replagal

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 1mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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