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01 6Novartis Pharmaceuticals Australia Pty Limited

02 10Novartis Pharmaceuticals Corporation

03 2Novartis South Africa (Pty) Ltd

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PharmaCompass

01

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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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

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
Not Confirmed

Dabrafenibmesilat

Brand Name : Finley

Dosage Form : Dispergerbar tablett

Dosage Strength : 10 mg

Packaging : Boks 2 210item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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07

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
Not Confirmed

Dabrafenibum

Brand Name : Tafinlar

Dosage Form : Kaps

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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08

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
Not Confirmed

Dabrafenibum

Brand Name : Tafinlar

Dosage Form : Kaps

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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09

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
Not Confirmed

Dabrafenibum

Brand Name : Tafinlar

Dosage Form : Kaps

Dosage Strength : 75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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10

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
Not Confirmed

Dabrafenibum

Brand Name : Tafinlar

Dosage Form : Kaps

Dosage Strength : 75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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11

Novartis South Africa (Pty) Ltd

Country
2024 ACI Convention
Not Confirmed
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Novartis South Africa (Pty) Ltd

Country
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2024 ACI Convention
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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12

Novartis South Africa (Pty) Ltd

Country
2024 ACI Convention
Not Confirmed
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Novartis South Africa (Pty) Ltd

Country
arrow
2024 ACI Convention
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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13

Novartis Pharmaceuticals Australia ...

Country
2024 ACI Convention
Not Confirmed
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Novartis Pharmaceuticals Australia ...

Country
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2024 ACI Convention
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
2024 ACI Convention
Not Confirmed
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Novartis Pharmaceuticals Australia ...

Country
arrow
2024 ACI Convention
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
2024 ACI Convention
Not Confirmed
arrow

Novartis Pharmaceuticals Australia ...

Country
arrow
2024 ACI Convention
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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16

Novartis Pharmaceuticals Australia ...

Country
2024 ACI Convention
Not Confirmed
arrow

Novartis Pharmaceuticals Australia ...

Country
arrow
2024 ACI Convention
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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17

Novartis Pharmaceuticals Australia ...

Country
2024 ACI Convention
Not Confirmed
arrow

Novartis Pharmaceuticals Australia ...

Country
arrow
2024 ACI Convention
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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18

Novartis Pharmaceuticals Australia ...

Country
2024 ACI Convention
Not Confirmed
arrow

Novartis Pharmaceuticals Australia ...

Country
arrow
2024 ACI Convention
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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