01 2Hikma Pharmaceuticals
02 40Novartis Pharmaceuticals Corporation
03 2Novartis South Africa (Pty) Ltd
01 2FCT
02 10Film Coated Tablet
03 2Film-Coated Tablet
04 1POWDER FOR SOLUTION
05 5Powder For Oral Solution
06 2SOLUTION;ORAL
07 2TABLET
08 6TABLET;ORAL
09 14Blank
01 3Allowed
02 3Approved
03 4Authorized
04 3DISCN
05 1Deregistered
06 3Marketed
07 2Originator
08 6Prescription
09 3RX
10 16Blank
01 9MEKINIST
02 1MEKINIST 2 mg
03 1MEQSEL 0,50 mg
04 27Mekinist
05 1Specxtras
06 3Spexotras
07 2TRAMETINIB DIMETHYL SULFOXIDE
01 14Australia
02 3Canada
03 3Estonia
04 3Norway
05 2South Africa
06 4Spain
07 4Sweden
08 3Switzerland
09 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Dosage Strength : EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 : 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 : Marketed
Registration Country : Norway
Brand Name : Mekinist
Dosage Form : Film Coated Tablet
Dosage Strength : 0.5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway
Regulatory Info : Marketed
Registration Country : Norway
Brand Name : Mekinist
Dosage Form : Film Coated Tablet
Dosage Strength : 2mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway
Regulatory Info : Marketed
Registration Country : Norway
Brand Name : Spexotras
Dosage Form : Powder For Oral Solution
Dosage Strength : 0.05mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway
Regulatory Info : Prescription
Registration Country : Estonia
Brand Name : Spexotras
Dosage Form : Powder For Oral Solution
Dosage Strength : 5mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia
Regulatory Info : Prescription
Registration Country : Estonia
Brand Name : Mekinist
Dosage Form : Film-Coated Tablet
Dosage Strength : 0.5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia
