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01 20Novartis Pharmaceuticals Corporation

02 1Novartis South Africa (Pty) Ltd

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PharmaCompass

01

CPhI India
Not Confirmed
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CPhI India
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ASCIMINIB HYDROCHLORIDE

Brand Name : SCEMBLIX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 20MG BASE

Packaging :

Approval Date : 2021-10-29

Application Number : 215358

Regulatory Info : RX

Registration Country : USA

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02

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

ASCIMINIB HYDROCHLORIDE

Brand Name : SCEMBLIX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 40MG BASE

Packaging :

Approval Date : 2021-10-29

Application Number : 215358

Regulatory Info : RX

Registration Country : USA

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03

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

ASCIMINIB HYDROCHLORIDE

Brand Name : SCEMBLIX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 100MG BASE

Packaging :

Approval Date : 2024-04-18

Application Number : 215358

Regulatory Info : RX

Registration Country : USA

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04

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Asciminib Hydrochloride

Brand Name : Scemblix

Dosage Form : Film Coated Tablet

Dosage Strength : 20mg

Packaging :

Approval Date : 25/08/2022

Application Number : 20210623000019

Regulatory Info : Approved

Registration Country : Sweden

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05

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Asciminib Hydrochloride

Brand Name : Scemblix

Dosage Form : Film Coated Tablet

Dosage Strength : 40mg

Packaging :

Approval Date : 25/08/2022

Application Number : 20210623000026

Regulatory Info : Approved

Registration Country : Sweden

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06

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Asciminibus

Brand Name : Scemblix

Dosage Form : Film Coated Tablet

Dosage Strength : 20mg

Packaging :

Approval Date : 09/06/2022

Application Number : 68441

Regulatory Info : Allowed

Registration Country : Switzerland

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07

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Asciminibus

Brand Name : Scemblix

Dosage Form : Film Coated Tablet

Dosage Strength : 40mg

Packaging :

Approval Date : 09/06/2022

Application Number : 68441

Regulatory Info : Allowed

Registration Country : Switzerland

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08

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Asciminibus

Brand Name : Scemblix

Dosage Form : Film Coated Tablet

Dosage Strength : 100mg

Packaging :

Approval Date : 09/06/2022

Application Number : 68441

Regulatory Info : Allowed

Registration Country : Switzerland

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09

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Asciminibus

Brand Name : Scemblix

Dosage Form : Film Coated Tablet

Dosage Strength : 20mg

Packaging :

Approval Date : 09/06/2022

Application Number : 68441

Regulatory Info : Allowed

Registration Country : Switzerland

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10

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Asciminibus

Brand Name : Scemblix

Dosage Form : Film Coated Tablet

Dosage Strength : 40mg

Packaging :

Approval Date : 09/06/2022

Application Number : 68441

Regulatory Info : Allowed

Registration Country : Switzerland

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11

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Asciminibus

Brand Name : Scemblix

Dosage Form : Film Coated Tablet

Dosage Strength : 100mg

Packaging :

Approval Date : 09/06/2022

Application Number : 68441

Regulatory Info : Allowed

Registration Country : Switzerland

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12

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Asciminib Hydrochloride

Brand Name : Scemblix

Dosage Form : Film Coated Tablet

Dosage Strength : 40MG

Packaging :

Approval Date : 2022-10-06

Application Number : 1221670004

Regulatory Info : Authorized

Registration Country : Spain

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13

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Asciminib Hydrochloride

Brand Name : Scemblix

Dosage Form : Film Coated Tablet

Dosage Strength : 20MG

Packaging :

Approval Date : 2022-10-06

Application Number : 1221670002

Regulatory Info : Authorized

Registration Country : Spain

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14

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

ASCIMINIB (ASCIMINIB HYDROCHLORIDE)

Brand Name : SCEMBLIX

Dosage Form : TABLET

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number : 2528320

Regulatory Info : Prescription

Registration Country : Canada

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15

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

ASCIMINIB (ASCIMINIB HYDROCHLORIDE)

Brand Name : SCEMBLIX

Dosage Form : TABLET

Dosage Strength : 40MG

Packaging :

Approval Date :

Application Number : 2528339

Regulatory Info : Prescription

Registration Country : Canada

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16

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

asciminib

Brand Name : Scemblix

Dosage Form :

Dosage Strength :

Packaging : 60

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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17

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

asciminib

Brand Name : Scemblix

Dosage Form :

Dosage Strength :

Packaging : 60

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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18

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

asciminib

Brand Name : Scemblix

Dosage Form :

Dosage Strength :

Packaging : 60

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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19

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

asciminib

Brand Name : Scemblix

Dosage Form :

Dosage Strength :

Packaging : 60

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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20

Novartis South Africa (Pty) Ltd

Country
CPhI India
Not Confirmed
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Novartis South Africa (Pty) Ltd

Country
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CPhI India
Not Confirmed

asciminib hydrochloride

Brand Name : BACRELBA 40

Dosage Form : FCT

Dosage Strength : 40mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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