01 6Novartis Pharmaceuticals Australia Pty Limited
02 14Novartis Pharmaceuticals Corporation
03 2Novartis South Africa (Pty) Ltd
04 2Novugen
01 2FCT
02 4Film-Coated Tablets
03 1POWDER FOR SOLUTION
04 1Powder for oral solution, solution
05 2SOLUTION;ORAL
06 2TABLET
07 6TABLET;ORAL
08 6Blank
01 3DISCN
02 2Originator
03 3Prescription
04 3RX
05 13Blank
01 9MEKINIST
02 1MEKINIST 2 mg
03 1MEQSEL 0,50 mg
04 10Mekinist
05 1Spexotras
06 2TRAMETINIB DIMETHYL SULFOXIDE
01 6Australia
02 3Canada
03 1Norway
04 2South Africa
05 4Switzerland
06 8USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MEKINIST
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG
Packaging :
Approval Date : 2013-05-29
Application Number : 204114
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : MEKINIST
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2013-05-29
Application Number : 204114
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MEKINIST
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 2MG
Packaging :
Approval Date : 2013-05-29
Application Number : 204114
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MEKINIST
Dosage Form : SOLUTION;ORAL
Dosage Strength : EQ 0.05MG BASE/ML
Packaging :
Approval Date : 2023-03-16
Application Number : 217513
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : MEKINIST
Dosage Form : TABLET;ORAL
Dosage Strength : 2MG
Packaging :
Approval Date :
Application Number : 217513
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : MEKINIST
Dosage Form : SOLUTION;ORAL
Dosage Strength : 4.7MG
Packaging :
Approval Date :
Application Number : 217513
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : Norway
Brand Name : Spexotras
Dosage Form : Powder for oral solution, solution
Dosage Strength : 0.05 mg/ml
Packaging : Bottle 1item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Mekinist
Dosage Form : Film-Coated Tablets
Dosage Strength : 0.5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Mekinist
Dosage Form : Film-Coated Tablets
Dosage Strength : 0.5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Mekinist
Dosage Form : Film-Coated Tablets
Dosage Strength : 2mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Mekinist
Dosage Form : Film-Coated Tablets
Dosage Strength : 2mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : MEKINIST
Dosage Form : TABLET
Dosage Strength : 0.5MG
Packaging : 30
Approval Date :
Application Number : 2409623
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : MEKINIST
Dosage Form : TABLET
Dosage Strength : 2MG
Packaging : 30
Approval Date :
Application Number : 2409658
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : MEKINIST
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 4.7MG
Packaging :
Approval Date :
Application Number : 2539993
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : DISCN
Registration Country : USA
Brand Name : TRAMETINIB DIMETHYL SULFOXIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG
Packaging :
Approval Date : 2024-08-06
Application Number : 219002
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : TRAMETINIB DIMETHYL SULFOXIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 2MG
Packaging :
Approval Date : 2024-08-06
Application Number : 219002
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : MEKINIST 2 mg
Dosage Form : FCT
Dosage Strength : 2mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : MEQSEL 0,50 mg
Dosage Form : FCT
Dosage Strength : 0.5mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Mekinist
Dosage Form :
Dosage Strength :
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Mekinist
Dosage Form :
Dosage Strength :
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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