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Synopsis

ACTIVE PHARMA INGREDIENTS

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FDF Dossiers

DRUG PRODUCT COMPOSITIONS

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Chemistry

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FDF Dossiers

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01

IFT FIRST
Not Confirmed
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IFT FIRST
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VEDOLIZUMAB

Brand Name : ENTYVIO

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 300MG

Packaging :

Approval Date :

Application Number : 761133

Regulatory Info :

Registration Country : USA

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02

IFT FIRST
Not Confirmed
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IFT FIRST
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VEDOLIZUMAB

Brand Name : ENTYVIO

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : 108MG/0.68ML

Packaging :

Approval Date :

Application Number : 761359

Regulatory Info :

Registration Country : USA

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03

IFT FIRST
Not Confirmed
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Vedolizumabum

Brand Name : Entyvio

Dosage Form : Dry Sub

Dosage Strength : 300mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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04

IFT FIRST
Not Confirmed
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IFT FIRST
Not Confirmed

VEDOLIZUMAB

Brand Name : ENTYVIO

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 300MG/VIAL

Packaging : 255ML

Approval Date :

Application Number : 2436841

Regulatory Info :

Registration Country : Canada

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05

IFT FIRST
Not Confirmed
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IFT FIRST
Not Confirmed

VEDOLIZUMAB

Brand Name : ENTYVIO

Dosage Form : SOLUTION

Dosage Strength : 108MG/0.68ML

Packaging :

Approval Date :

Application Number : 2497867

Regulatory Info :

Registration Country : Canada

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06

IFT FIRST
Not Confirmed
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IFT FIRST
Not Confirmed

Vedolizumab

Brand Name : Entyvio®

Dosage Form : INF

Dosage Strength : 300mg

Packaging : 5X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

Country
IFT FIRST
Not Confirmed
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IFT FIRST
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Vedolizumab

Brand Name : Entyvio

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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08

Country
IFT FIRST
Not Confirmed
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IFT FIRST
Not Confirmed

Vedolizumab

Brand Name : Entyvio

Dosage Form :

Dosage Strength :

Packaging : 2

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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09

Country
IFT FIRST
Not Confirmed
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IFT FIRST
Not Confirmed

Vedolizumab

Brand Name : Entyvio

Dosage Form :

Dosage Strength :

Packaging : 2

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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10

Country
IFT FIRST
Not Confirmed
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IFT FIRST
Not Confirmed

Vedolizumab

Brand Name : Entyvio

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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