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01 2Hikma Pharmaceuticals
02 12Novartis Pharmaceuticals Australia Pty Limited
03 21Novartis Pharmaceuticals Corporation
04 2Novartis South Africa (Pty) Ltd
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01 2FCT
02 8Film Coated Tablet
03 1POWDER FOR SOLUTION
04 3Powder For Oral Solution
05 1Powder for oral solution, solution
06 2SOLUTION;ORAL
07 2TABLET
08 6TABLET;ORAL
09 12Blank
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01 3Allowed
02 3Approved
03 4Authorized
04 3DISCN
05 1Deregistered
06 2Originator
07 3Prescription
08 3RX
09 15Blank
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01 9MEKINIST
02 1MEKINIST 2 mg
03 1MEQSEL 0,50 mg
04 21Mekinist
05 1Specxtras
06 2Spexotras
07 2TRAMETINIB DIMETHYL SULFOXIDE
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01 12Australia
02 3Canada
03 1Norway
04 2South Africa
05 4Spain
06 4Sweden
07 3Switzerland
08 8USA
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 : 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Dosage Strength : EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 : Approved
Registration Country : Sweden
Brand Name : Mekinist
Dosage Form : Film Coated Tablet
Dosage Strength : 0.5mg
Packaging :
Approval Date : 30/06/2014
Application Number : 20130212000025
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Mekinist
Dosage Form : Film Coated Tablet
Dosage Strength : 2mg
Packaging :
Approval Date : 30/06/2014
Application Number : 20130212000056
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Specxtras
Dosage Form : Powder For Oral Solution
Dosage Strength : 0.05mg/ml
Packaging :
Approval Date : 05/01/2024
Application Number : 20220912000040
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Mekinist
Dosage Form : Film Coated Tablet
Dosage Strength :
Packaging :
Approval Date : 30/06/2014
Application Number : 20130212000049
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Mekinist
Dosage Form : Film Coated Tablet
Dosage Strength : 0.5mg
Packaging :
Approval Date : 22/02/2016
Application Number : 65883
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Mekinist
Dosage Form : Film Coated Tablet
Dosage Strength : 2mg
Packaging :
Approval Date : 22/02/2016
Application Number : 65883
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Mekinist
Dosage Form : Powder For Oral Solution
Dosage Strength : 4.7mg
Packaging :
Approval Date : 05/09/2023
Application Number : 69134
Regulatory Info : Allowed
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 : 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
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