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01 1Alembic Pharmaceuticals Limited
02 2Pfizer Inc
03 8Pierre Fabre
04 1TEVA PHARMACEUTICALS USA, INC.
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01 6Film Coated Tablet
02 2TABLET
03 2TABLET;ORAL
04 2Blank
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01 2Allowed
02 2Approved
03 2Authorized
04 1Prescription
05 1RX
06 4Blank
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01 2BINIMETINIB
02 2MEKTOVI
03 8Mektovi
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01 2Australia
02 1Canada
03 2Spain
04 2Sweden
05 2Switzerland
06 3USA
Regulatory Info :
Registration Country : USA
Brand Name : BINIMETINIB
Dosage Form : TABLET;ORAL
Dosage Strength : 15MG
Packaging :
Approval Date :
Application Number : 217678
Regulatory Info :
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MEKTOVI
Dosage Form : TABLET;ORAL
Dosage Strength : 15MG
Packaging :
Approval Date : 2018-06-27
Application Number : 210498
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : MEKTOVI
Dosage Form : TABLET
Dosage Strength : 15MG
Packaging :
Approval Date :
Application Number : 2513080
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Mektovi
Dosage Form : Film Coated Tablet
Dosage Strength : 15mg
Packaging :
Approval Date : 20/09/2018
Application Number : 20170728000089
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Mektovi
Dosage Form : Film Coated Tablet
Dosage Strength : 45mg
Packaging :
Approval Date : 17/06/2024
Application Number : 20230911000118
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Mektovi
Dosage Form : Film Coated Tablet
Dosage Strength : 15mg
Packaging :
Approval Date : 01/11/2019
Application Number : 66907
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Mektovi
Dosage Form : Film Coated Tablet
Dosage Strength : 45mg
Packaging :
Approval Date : 01/11/2019
Application Number : 66907
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info :
Registration Country : Australia
Brand Name : Mektovi
Dosage Form :
Dosage Strength :
Packaging : 84
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Mektovi
Dosage Form :
Dosage Strength :
Packaging : 84
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Mektovi
Dosage Form : Film Coated Tablet
Dosage Strength : 45MG
Packaging :
Approval Date : 2024-10-08
Application Number : 1181315003
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Mektovi
Dosage Form : Film Coated Tablet
Dosage Strength : 15MG
Packaging :
Approval Date : 2018-10-19
Application Number : 1181315001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info :
Registration Country : USA
Brand Name : BINIMETINIB
Dosage Form : TABLET
Dosage Strength : 15MG
Packaging :
Approval Date :
Application Number : 217509
Regulatory Info :
Registration Country : USA
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