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01 17Novartis Pharmaceuticals Australia Pty Limited

02 9Novartis Pharmaceuticals Corporation

03 2Novartis South Africa (Pty) Ltd

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PharmaCompass

01

AIChE Annual Meeting
Not Confirmed
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AIChE Annual Meeting
Not Confirmed

DABRAFENIB MESYLATE

Brand Name : TAFINLAR

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 50MG BASE

Packaging :

Approval Date : 2013-05-29

Application Number : 202806

Regulatory Info : RX

Registration Country : USA

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02

AIChE Annual Meeting
Not Confirmed
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AIChE Annual Meeting
Not Confirmed

DABRAFENIB MESYLATE

Brand Name : TAFINLAR

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 75MG BASE

Packaging :

Approval Date : 2013-05-29

Application Number : 202806

Regulatory Info : RX

Registration Country : USA

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03

AIChE Annual Meeting
Not Confirmed
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AIChE Annual Meeting
Not Confirmed

DABRAFENIB MESYLATE

Brand Name : TAFINLAR

Dosage Form : TABLET, FOR SUSPENSION;ORAL

Dosage Strength : EQ 10MG BASE

Packaging :

Approval Date : 2023-03-16

Application Number : 217514

Regulatory Info : RX

Registration Country : USA

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04

AIChE Annual Meeting
Not Confirmed
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AIChE Annual Meeting
Not Confirmed

DABRAFENIB MESYLATE

Brand Name : TAFINLAR

Dosage Form : CAPSULE;ORAL

Dosage Strength : 75MG

Packaging :

Approval Date :

Application Number : 217514

Regulatory Info :

Registration Country : USA

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05

AIChE Annual Meeting
Not Confirmed
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arrow
AIChE Annual Meeting
Not Confirmed

DABRAFENIB MESYLATE

Brand Name : TAFINLAR

Dosage Form : TABLET; ORAL SUSPENSION

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 217514

Regulatory Info :

Registration Country : USA

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06

AIChE Annual Meeting
Not Confirmed
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AIChE Annual Meeting
Not Confirmed

Dabrafenibmesilat

Brand Name : Finley

Dosage Form : Dispersible tablet

Dosage Strength : 10 mg

Packaging : Boks 2 210item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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07

AIChE Annual Meeting
Not Confirmed
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arrow
AIChE Annual Meeting
Not Confirmed

Dabrafenib Mesylate

Brand Name : Tafinlar

Dosage Form : Hard Capsule

Dosage Strength : 50MG

Packaging :

Approval Date : 2014-02-26

Application Number : 113865001

Regulatory Info : Authorized

Registration Country : Spain

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08

AIChE Annual Meeting
Not Confirmed
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arrow
AIChE Annual Meeting
Not Confirmed

Dabrafenib Mesylate

Brand Name : Tafinlar

Dosage Form : Hard Capsule

Dosage Strength : 75MG

Packaging :

Approval Date : 2013-09-30

Application Number : 113865003

Regulatory Info : Authorized

Registration Country : Spain

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09

AIChE Annual Meeting
Not Confirmed
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AIChE Annual Meeting
Not Confirmed

Dabrafenib Mesylate

Brand Name : Finlee

Dosage Form : Dispersible Tablet

Dosage Strength : 10MG

Packaging :

Approval Date : 2024-04-12

Application Number : 1231767001

Regulatory Info : Authorized

Registration Country : Spain

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10

Novartis South Africa (Pty) Ltd

Country
AIChE Annual Meeting
Not Confirmed
arrow

Novartis South Africa (Pty) Ltd

Country
arrow
AIChE Annual Meeting
Not Confirmed

Dabrafenib

Brand Name : Rafinlar 75 mg

Dosage Form : CAP

Dosage Strength : 75mg

Packaging : 120X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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11

Novartis South Africa (Pty) Ltd

Country
AIChE Annual Meeting
Not Confirmed
arrow

Novartis South Africa (Pty) Ltd

Country
arrow
AIChE Annual Meeting
Not Confirmed

Dabrafenib

Brand Name : Rafinlar 50 mg

Dosage Form : CAP

Dosage Strength : 50mg

Packaging : 120X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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12

Novartis Pharmaceuticals Australia ...

Country
AIChE Annual Meeting
Not Confirmed
arrow

Novartis Pharmaceuticals Australia ...

Country
arrow
AIChE Annual Meeting
Not Confirmed

Dabrafenib

Brand Name : Tafinlar

Dosage Form :

Dosage Strength :

Packaging : 120

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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13

Novartis Pharmaceuticals Australia ...

Country
AIChE Annual Meeting
Not Confirmed
arrow

Novartis Pharmaceuticals Australia ...

Country
arrow
AIChE Annual Meeting
Not Confirmed

Dabrafenib

Brand Name : Tafinlar

Dosage Form :

Dosage Strength :

Packaging : 120

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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14

Novartis Pharmaceuticals Australia ...

Country
AIChE Annual Meeting
Not Confirmed
arrow

Novartis Pharmaceuticals Australia ...

Country
arrow
AIChE Annual Meeting
Not Confirmed

Dabrafenib

Brand Name : Tafinlar

Dosage Form :

Dosage Strength :

Packaging : 120

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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15

Novartis Pharmaceuticals Australia ...

Country
AIChE Annual Meeting
Not Confirmed
arrow

Novartis Pharmaceuticals Australia ...

Country
arrow
AIChE Annual Meeting
Not Confirmed

Dabrafenib

Brand Name : Tafinlar

Dosage Form :

Dosage Strength :

Packaging : 420

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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16

Novartis Pharmaceuticals Australia ...

Country
AIChE Annual Meeting
Not Confirmed
arrow

Novartis Pharmaceuticals Australia ...

Country
arrow
AIChE Annual Meeting
Not Confirmed

Dabrafenib

Brand Name : Tafinlar

Dosage Form :

Dosage Strength :

Packaging : 420

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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17

Novartis Pharmaceuticals Australia ...

Country
AIChE Annual Meeting
Not Confirmed
arrow

Novartis Pharmaceuticals Australia ...

Country
arrow
AIChE Annual Meeting
Not Confirmed

Dabrafenib

Brand Name : Tafinlar

Dosage Form :

Dosage Strength :

Packaging : 120

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

blank

18

Novartis Pharmaceuticals Australia ...

Country
AIChE Annual Meeting
Not Confirmed
arrow

Novartis Pharmaceuticals Australia ...

Country
arrow
AIChE Annual Meeting
Not Confirmed

Dabrafenib

Brand Name : Tafinlar

Dosage Form :

Dosage Strength :

Packaging : 120

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

blank

19

Novartis Pharmaceuticals Australia ...

Country
AIChE Annual Meeting
Not Confirmed
arrow

Novartis Pharmaceuticals Australia ...

Country
arrow
AIChE Annual Meeting
Not Confirmed

Dabrafenib

Brand Name : Tafinlar

Dosage Form :

Dosage Strength :

Packaging : 120

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

blank

20

Novartis Pharmaceuticals Australia ...

Country
AIChE Annual Meeting
Not Confirmed
arrow

Novartis Pharmaceuticals Australia ...

Country
arrow
AIChE Annual Meeting
Not Confirmed

Dabrafenib

Brand Name : Tafinlar

Dosage Form :

Dosage Strength :

Packaging : 120

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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