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Chemistry

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FDF Dossiers

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01

ACS Fall 2025
Not Confirmed
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ACS Fall 2025
Not Confirmed

ECULIZUMAB

Brand Name : SOLIRIS

Dosage Form : SOLUTION

Dosage Strength : 10MG/ML

Packaging : 30ML

Approval Date :

Application Number : 2322285

Regulatory Info :

Registration Country : Canada

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02

ACS Fall 2025
Not Confirmed
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ACS Fall 2025
Not Confirmed

Eculizumab

Brand Name : Soliris

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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03

ACS Fall 2025
Not Confirmed
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ACS Fall 2025
Not Confirmed

Eculizumab

Brand Name : Soliris

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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04

ACS Fall 2025
Not Confirmed
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ACS Fall 2025
Not Confirmed

Eculizumab

Brand Name : Soliris

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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05

ACS Fall 2025
Not Confirmed
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ACS Fall 2025
Not Confirmed

Eculizumab

Brand Name : Soliris

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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06

ACS Fall 2025
Not Confirmed
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ACS Fall 2025
Not Confirmed

Eculizumab

Brand Name : Soliris

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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07

ACS Fall 2025
Not Confirmed
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ACS Fall 2025
Not Confirmed

Eculizumab

Brand Name : Soliris

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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08

ACS Fall 2025
Not Confirmed
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ACS Fall 2025
Not Confirmed

Eculizumab

Brand Name : Soliris

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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09

ACS Fall 2025
Not Confirmed
arrow
arrow
ACS Fall 2025
Not Confirmed

Eculizumab

Brand Name : Soliris

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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10

Amgen Inc

U.S.A
ACS Fall 2025
Not Confirmed
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Amgen Inc

U.S.A
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ACS Fall 2025
Not Confirmed

ECULIZUMAB-AEEB

Brand Name : BKEMV

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 300MG/30ML(10MG/ML)

Packaging :

Approval Date :

Application Number : 761333

Regulatory Info :

Registration Country : USA

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