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01 39Novartis Pharmaceuticals Corporation

02 2Novartis South Africa (Pty) Ltd

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PharmaCompass

01

ASPEN
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ASPEN
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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

ASPEN
Not Confirmed
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ASPEN
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

ASPEN
Not Confirmed
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ASPEN
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

ASPEN
Not Confirmed
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ASPEN
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

ASPEN
Not Confirmed
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ASPEN
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

ASPEN
Not Confirmed
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ASPEN
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Dabrafenib mesilate

Brand Name : Finlee

Dosage Form : Dispersible Tablet

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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07

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Dabrafenib mesilate

Brand Name : Tafinlar

Dosage Form : Capsule

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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08

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Dabrafenib mesilate

Brand Name : Tafinlar

Dosage Form : Capsule

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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09

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Dabrafenib mesilate

Brand Name : Tafinlar

Dosage Form : Capsule

Dosage Strength : 75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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10

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Dabrafenib mesilate

Brand Name : Tafinlar

Dosage Form : Capsule

Dosage Strength : 75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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11

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Dabrafenib

Brand Name : Finlee

Dosage Form : Dispersible Tablet

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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12

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Dabrafenib

Brand Name : Tafinlar

Dosage Form : Capsule

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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13

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Dabrafenib

Brand Name : Tafinlar

Dosage Form : Capsule

Dosage Strength : 75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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14

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Dabrafenib Mesylate

Brand Name : Tafinlar

Dosage Form : Hard Capsule

Dosage Strength : 50MG

Packaging :

Approval Date : 26-02-2014

Application Number : 113865001

Regulatory Info : Authorized

Registration Country : Spain

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15

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Dabrafenib Mesylate

Brand Name : Tafinlar

Dosage Form : Hard Capsule

Dosage Strength : 75MG

Packaging :

Approval Date : 30-09-2013

Application Number : 113865003

Regulatory Info : Authorized

Registration Country : Spain

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16

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Dabrafenib Mesylate

Brand Name : Finlee

Dosage Form : Dispersible Tablet

Dosage Strength : 10MG

Packaging :

Approval Date : 12-04-2024

Application Number : 1231767001

Regulatory Info : Authorized

Registration Country : Spain

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17

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

DABRAFENIB (DABRAFENIB MESYLATE)

Brand Name : TAFINLAR

Dosage Form : CAPSULE

Dosage Strength : 50MG

Packaging : 120

Approval Date :

Application Number : 2409607

Regulatory Info : Prescription

Registration Country : Canada

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18

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

DABRAFENIB (DABRAFENIB MESYLATE)

Brand Name : TAFINLAR

Dosage Form : CAPSULE

Dosage Strength : 75MG

Packaging : 120

Approval Date :

Application Number : 2409615

Regulatory Info : Prescription

Registration Country : Canada

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19

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

DABRAFENIB (DABRAFENIB MESYLATE)

Brand Name : TAFINLAR

Dosage Form : TABLET FOR SUSPENSION

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 2540053

Regulatory Info : Prescription

Registration Country : Canada

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20

Novartis South Africa (Pty) Ltd

Country
ASPEN
Not Confirmed
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Novartis South Africa (Pty) Ltd

Country
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ASPEN
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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