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01 9Novartis Pharmaceuticals Corporation

02 1Novartis South Africa (Pty) Ltd

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PharmaCompass

01

CTAD25
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CTAD25
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CERITINIB

Brand Name : ZYKADIA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 150MG

Packaging :

Approval Date : 2014-04-29

Application Number : 205755

Regulatory Info : DISCN

Registration Country : USA

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02

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

CERITINIB

Brand Name : ZYKADIA

Dosage Form : TABLET;ORAL

Dosage Strength : 150MG

Packaging :

Approval Date : 2019-03-18

Application Number : 211225

Regulatory Info : RX

Registration Country : USA

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03

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Ceritinib

Brand Name : Zykadia

Dosage Form : Film Coated Tablet

Dosage Strength : 150mg

Packaging :

Approval Date : 02/04/2019

Application Number : 20180426000052

Regulatory Info : Approved

Registration Country : Sweden

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04

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Ceritinib

Brand Name : Zykadia

Dosage Form : Capsule

Dosage Strength : 150mg

Packaging :

Approval Date : 06/05/2015

Application Number : 20140327000049

Regulatory Info : Approved

Registration Country : Sweden

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05

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Ceritinib

Brand Name : Zykadia

Dosage Form : Capsule

Dosage Strength : 150mg

Packaging :

Approval Date : 25/08/2015

Application Number : 65386

Regulatory Info : Allowed

Registration Country : Switzerland

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06

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Ceritinib

Brand Name : Zykadia

Dosage Form : Film Coated Tablet

Dosage Strength : 150mg

Packaging :

Approval Date : 16/03/2020

Application Number : 67233

Regulatory Info : Allowed

Registration Country : Switzerland

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07

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Ceritinib

Brand Name : Zykadia

Dosage Form : Hard Capsule

Dosage Strength : 150MG

Packaging :

Approval Date : 2015-06-24

Application Number : 115999001

Regulatory Info : Authorized

Registration Country : Spain

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08

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

CERITINIB

Brand Name : ZYKADIA

Dosage Form : CAPSULE

Dosage Strength : 150MG

Packaging : 150

Approval Date :

Application Number : 2436779

Regulatory Info : Prescription

Registration Country : Canada

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09

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Ceritinib

Brand Name : Zykadia

Dosage Form :

Dosage Strength :

Packaging : 150

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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10

Novartis South Africa (Pty) Ltd

Country
CTAD25
Not Confirmed
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Novartis South Africa (Pty) Ltd

Country
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CTAD25
Not Confirmed

Ceritinib

Brand Name : ZYKADIA

Dosage Form : CAP

Dosage Strength : 150mg

Packaging : 90X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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