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Chemistry

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FDF Dossiers

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01

AIChE Annual Meeting
Not Confirmed
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AIChE Annual Meeting
Not Confirmed

ECULIZUMAB

Brand Name : SOLIRIS

Dosage Form : INJECTABLE; IV (INFUSION)

Dosage Strength : 300MG

Packaging :

Approval Date :

Application Number : 125166

Regulatory Info :

Registration Country : USA

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02

AIChE Annual Meeting
Not Confirmed
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AIChE Annual Meeting
Not Confirmed

Eculizumab

Brand Name : Soliris

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 10mg/ml

Packaging :

Approval Date : 20/06/2007

Application Number : 20061202000018

Regulatory Info : Approved

Registration Country : Sweden

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03

AIChE Annual Meeting
Not Confirmed
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AIChE Annual Meeting
Not Confirmed

Eculizumab

Brand Name : Soliris

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 300mg/30ml

Packaging :

Approval Date : 04/01/2010

Application Number : 59282

Regulatory Info : Allowed

Registration Country : Switzerland

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04

AIChE Annual Meeting
Not Confirmed
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AIChE Annual Meeting
Not Confirmed

Eculizumab

Brand Name : Soliris

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 300MG

Packaging :

Approval Date : 2007-08-07

Application Number : 07393001

Regulatory Info : Authorized

Registration Country : Spain

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05

AIChE Annual Meeting
Not Confirmed
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AIChE Annual Meeting
Not Confirmed

ECULIZUMAB

Brand Name : SOLIRIS

Dosage Form : SOLUTION

Dosage Strength : 10MG/ML

Packaging : 30ML

Approval Date :

Application Number : 2322285

Regulatory Info : Schedule D

Registration Country : Canada

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06

Amgen Inc

U.S.A
AIChE Annual Meeting
Not Confirmed
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Amgen Inc

U.S.A
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AIChE Annual Meeting
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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07

Amgen Inc

U.S.A
AIChE Annual Meeting
Not Confirmed
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Amgen Inc

U.S.A
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AIChE Annual Meeting
Not Confirmed

Eculizumab

Brand Name : Bekemv

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 300mg

Packaging :

Approval Date : 19/04/2023

Application Number : 20220304000061

Regulatory Info : Approved

Registration Country : Sweden

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08

Amgen Inc

U.S.A
AIChE Annual Meeting
Not Confirmed
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Amgen Inc

U.S.A
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AIChE Annual Meeting
Not Confirmed

Eculizumab

Brand Name : Bekemv

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 300MG

Packaging :

Approval Date : 2023-04-27

Application Number : 1231727001

Regulatory Info : Authorized

Registration Country : Spain

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09

Samsung Bioepis

South Korea
AIChE Annual Meeting
Not Confirmed
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Samsung Bioepis

South Korea
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AIChE Annual Meeting
Not Confirmed

ECULIZUMAB-AAGH

Brand Name : EPYSQLI

Dosage Form : INJECTION;SOLUTION

Dosage Strength : 300 mg/30 mL (10 mg/mL)

Packaging :

Approval Date :

Application Number : 761340

Regulatory Info :

Registration Country : USA

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10

Samsung Bioepis

South Korea
AIChE Annual Meeting
Not Confirmed
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Samsung Bioepis

South Korea
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AIChE Annual Meeting
Not Confirmed

Eculizumab

Brand Name : Epysqli

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 300mg

Packaging :

Approval Date : 26/05/2023

Application Number : 20220623000025

Regulatory Info : Approved

Registration Country : Sweden

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