01 2Hikma Pharmaceuticals
02 12Novartis Pharmaceuticals Australia Pty Limited
03 21Novartis Pharmaceuticals Corporation
04 2Novartis South Africa (Pty) Ltd
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
01 3Allowed
02 3Approved
03 4Authorized
04 3DISCN
05 1Deregistered
06 2Originator
07 3Prescription
08 3RX
09 15Blank
01 9MEKINIST
02 1MEKINIST 2 mg
03 1MEQSEL 0,50 mg
04 21Mekinist
05 1Specxtras
06 2Spexotras
07 2TRAMETINIB DIMETHYL SULFOXIDE
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Dosage Strength : EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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