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01 1Sanofi

02 1SHIRE PLC

03 6Takeda Pharmaceutical

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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 : Originator

Registration Country : South Africa

Idursulfase

Brand Name : Elaprase

Dosage Form : INJ

Dosage Strength : 2mg/ml

Packaging : 3X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Sanofi Company Banner

02

ISPE Annual Meeting
Not Confirmed
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ISPE Annual Meeting
Not Confirmed

IDURSULFASE

Brand Name : ELAPRASE

Dosage Form : INJECTABLE; IV (INFUSION)

Dosage Strength : 6MG/3ML

Packaging :

Approval Date :

Application Number : 125151

Regulatory Info :

Registration Country : USA

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03

ISPE Annual Meeting
Not Confirmed
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ISPE Annual Meeting
Not Confirmed

Idursulfase

Brand Name : Elaprase

Dosage Form : Concentrate for infusion solution, solution

Dosage Strength : 2 mg/ml

Packaging : Vials 1 3ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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04

ISPE Annual Meeting
Not Confirmed
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ISPE Annual Meeting
Not Confirmed

Idursulfase

Brand Name : Elaprase

Dosage Form : Concentrate for infusion solution, solution

Dosage Strength : 2 mg/ml

Packaging : Vials 4 3ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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05

ISPE Annual Meeting
Not Confirmed
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ISPE Annual Meeting
Not Confirmed

Idursulfas

Brand Name : Elaprase

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 2mg/ml

Packaging :

Approval Date : 08/01/2007

Application Number : 20060105000040

Regulatory Info : Approved

Registration Country : Sweden

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06

ISPE Annual Meeting
Not Confirmed
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ISPE Annual Meeting
Not Confirmed

Idursulfase

Brand Name : Elaprase

Dosage Form : Infusion Concentrate

Dosage Strength : 2mg/ml

Packaging :

Approval Date : 20/03/2007

Application Number : 57916

Regulatory Info : Allowed

Registration Country : Switzerland

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07

ISPE Annual Meeting
Not Confirmed
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ISPE Annual Meeting
Not Confirmed

IDURSULFASE

Brand Name : ELAPRASE

Dosage Form : SOLUTION

Dosage Strength : 2MG/ML

Packaging : 3ML

Approval Date :

Application Number : 2296314

Regulatory Info : Schedule D

Registration Country : Canada

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08

ISPE Annual Meeting
Not Confirmed
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ISPE Annual Meeting
Not Confirmed

Idursulfase

Brand Name : Elaprase

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 2MG

Packaging :

Approval Date : 2007-02-08

Application Number : 06365001

Regulatory Info : Authorized

Registration Country : Spain

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