01 2Hikma Pharmaceuticals
02 43Novartis Pharmaceuticals Corporation
03 2Novartis South Africa (Pty) Ltd
01 2FCT
02 12Film Coated Tablet
03 2Film-Coated Tablet
04 1POWDER FOR SOLUTION
05 6Powder 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 3PRESCRIPTION
09 6Prescription
10 3RX
11 16Blank
01 9MEKINIST
02 1MEKINIST 2 mg
03 1MEQSEL 0,50 mg
04 29Mekinist
05 1Specxtras
06 4Spexotras
07 2TRAMETINIB DIMETHYL SULFOXIDE
01 14Australia
02 3Canada
03 3Denmark
04 3Estonia
05 3Norway
06 2South Africa
07 4Spain
08 4Sweden
09 3Switzerland
10 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Dosage Strength : EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 : 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
Regulatory Info : Prescription
Registration Country : Estonia
Brand Name : Mekinist
Dosage Form : Film-Coated Tablet
Dosage Strength : 2mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Spexotras
Dosage Form : Powder For Oral Solution
Dosage Strength : 0.05MG
Packaging :
Approval Date : 10-04-2024
Application Number : 1231781001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Mekinist
Dosage Form : Film Coated Tablet
Dosage Strength : 2MG
Packaging :
Approval Date : 03-03-2025
Application Number : 114931006IP
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Mekinist
Dosage Form : Film Coated Tablet
Dosage Strength : 2MG
Packaging :
Approval Date : 24-09-2015
Application Number : 114931006
Regulatory Info : Authorized
Registration Country : Spain
