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    AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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    Ravulizumab

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    01

    Alexion Pharmaceuticals

    U.S.A
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    Regulatory Info :

    Registration Country : USA

    RAVULIZUMAB-CWVZ

    Brand Name : ULTOMIRIS

    Dosage Form : INJECTABLE;INJECTION

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

    Packaging :

    Approval Date :

    Application Number : 761108

    Regulatory Info :

    Registration Country : USA

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    02

    Alexion Pharmaceuticals

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    Alexion Pharmaceuticals

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    Regulatory Info : Approved

    Registration Country : Sweden

    Ravulizumab

    Brand Name : Ultomiris

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 1100mg/11ml

    Packaging :

    Approval Date : 18/11/2020

    Application Number : 20191122000116

    Regulatory Info : Approved

    Registration Country : Sweden

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    03

    Alexion Pharmaceuticals

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    Regulatory Info : Approved

    Registration Country : Sweden

    Ravulizumab

    Brand Name : Ultomiris

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 300mg/3ml

    Packaging :

    Approval Date : 18/11/2020

    Application Number : 20191122000109

    Regulatory Info : Approved

    Registration Country : Sweden

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    04

    Alexion Pharmaceuticals

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    Regulatory Info : Approved

    Registration Country : Sweden

    Ravulizumab

    Brand Name : Ultomiris

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 300mg/30ml

    Packaging :

    Approval Date : 02/07/2019

    Application Number : 20180628000034

    Regulatory Info : Approved

    Registration Country : Sweden

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    05

    Alexion Pharmaceuticals

    U.S.A
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Ravulizumab

    Brand Name : Ultomiris

    Dosage Form : Injectable Solution

    Dosage Strength : 245mg

    Packaging :

    Approval Date : 31/05/2023

    Application Number : 20220216000012

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    06

    Alexion Pharmaceuticals

    U.S.A
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Ravulizumab

    Brand Name : Ultomir

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 300mg/30ml

    Packaging :

    Approval Date : 20/01/2020

    Application Number : 67278

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    07

    Alexion Pharmaceuticals

    U.S.A
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Ravulizumab

    Brand Name : Ultomir

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 300mg/3ml

    Packaging :

    Approval Date : 20/01/2020

    Application Number : 67278

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    08

    Alexion Pharmaceuticals

    U.S.A
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Ravulizumab

    Brand Name : Ultomir

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 1100mg/11ml

    Packaging :

    Approval Date : 20/01/2020

    Application Number : 67278

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    09

    Alexion Pharmaceuticals

    U.S.A
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    Regulatory Info : Marketed

    Registration Country : Norway

    Ravulizumab

    Brand Name : Ultomiris

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 1100mg/11ml

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Marketed

    Registration Country : Norway

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    10

    Alexion Pharmaceuticals

    U.S.A
    ASPEN
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    Alexion Pharmaceuticals

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    ASPEN
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    Regulatory Info : Marketed

    Registration Country : Norway

    Ravulizumab

    Brand Name : Ultomiris

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 300mg/3ml

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Marketed

    Registration Country : Norway

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    11

    Alexion Pharmaceuticals

    U.S.A
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    Regulatory Info : Prescription

    Registration Country : Estonia

    ravulizumab

    Brand Name : Ultomiris

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 100mg/ml

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Prescription

    Registration Country : Estonia

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    12

    Alexion Pharmaceuticals

    U.S.A
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    Alexion Pharmaceuticals

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    Regulatory Info : Prescription

    Registration Country : Estonia

    ravulizumab

    Brand Name : Ultomiris

    Dosage Form : Solution For Injection

    Dosage Strength : 245mg/3.5ml

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Prescription

    Registration Country : Estonia

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    13

    Alexion Pharmaceuticals

    U.S.A
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    Alexion Pharmaceuticals

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    Regulatory Info : Prescription

    Registration Country : Estonia

    ravulizumab

    Brand Name : Ultomiris

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 300mg/30ml

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Prescription

    Registration Country : Estonia

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    14

    Alexion Pharmaceuticals

    U.S.A
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    Alexion Pharmaceuticals

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    Regulatory Info : Prescription

    Registration Country : Estonia

    ravulizumab

    Brand Name : Ultomiris

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 300mg/3ml

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Prescription

    Registration Country : Estonia

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    15

    Alexion Pharmaceuticals

    U.S.A
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    Alexion Pharmaceuticals

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    Regulatory Info : Authorized

    Registration Country : Spain

    Ravulizumab

    Brand Name : Ultomiris

    Dosage Form : Concentrate For Infusion Solution

    Dosage Strength : 300MG

    Packaging :

    Approval Date : 11-06-2021

    Application Number : 1191371002

    Regulatory Info : Authorized

    Registration Country : Spain

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    16

    Alexion Pharmaceuticals

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    Regulatory Info : Authorized

    Registration Country : Spain

    Ravulizumab

    Brand Name : Ultomiris

    Dosage Form : Concentrate For Infusion Solution

    Dosage Strength : 1100MG

    Packaging :

    Approval Date : 11-06-2021

    Application Number : 1191371003

    Regulatory Info : Authorized

    Registration Country : Spain

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    17

    Alexion Pharmaceuticals

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    Regulatory Info : Schedule D

    Registration Country : Canada

    RAVULIZUMAB

    Brand Name : ULTOMIRIS

    Dosage Form : SOLUTION

    Dosage Strength : 300MG/3ML

    Packaging :

    Approval Date :

    Application Number : 2533448

    Regulatory Info : Schedule D

    Registration Country : Canada

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    18

    Alexion Pharmaceuticals

    U.S.A
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    Regulatory Info : Schedule D

    Registration Country : Canada

    RAVULIZUMAB

    Brand Name : ULTOMIRIS

    Dosage Form : SOLUTION

    Dosage Strength : 1100MG/11ML

    Packaging :

    Approval Date :

    Application Number : 2533456

    Regulatory Info : Schedule D

    Registration Country : Canada

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    19

    AstraZeneca

    United Kingdom
    ASPEN
    Not Confirmed
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    AstraZeneca

    United Kingdom
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    Regulatory Info : Originator

    Registration Country : South Africa

    Ravulizumab

    Brand Name : Ultomiris 300 mg

    Dosage Form : INF

    Dosage Strength : 300mg/ml

    Packaging : 3X1mg/ml

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    20

    AstraZeneca

    United Kingdom
    ASPEN
    Not Confirmed
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    AstraZeneca

    United Kingdom
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    Regulatory Info : Originator

    Registration Country : South Africa

    Ravulizumab

    Brand Name : Ultomiris 1100 mg

    Dosage Form : INF

    Dosage Strength : 1100mg/ml

    Packaging : 11X1mg/ml

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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