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01 8Novartis Pharmaceuticals Corporation
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01 6Film Coated Tablet
02 2TABLET;ORAL
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01 2Allowed
02 2Approved
03 2Authorized
04 2RX
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01 2TABRECTA
02 2Table
03 4Tabrecta
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01 2Spain
02 2Sweden
03 2Switzerland
04 2USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TABRECTA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 150MG BASE
Packaging :
Approval Date : 2020-05-06
Application Number : 213591
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TABRECTA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 200MG BASE
Packaging :
Approval Date : 2020-05-06
Application Number : 213591
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Capmatinib Dihydrochloride Monohydrate
Brand Name : Tabrecta
Dosage Form : Film Coated Tablet
Dosage Strength : 150mg
Packaging :
Approval Date : 20/06/2022
Application Number : 20210416000240
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Capmatinib Dihydrochloride Monohydrate
Brand Name : Tabrecta
Dosage Form : Film Coated Tablet
Dosage Strength : 200mg
Packaging :
Approval Date : 20/06/2022
Application Number : 20210416000257
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Tabrecta
Dosage Form : Film Coated Tablet
Dosage Strength : 150mg
Packaging :
Approval Date : 26/04/2021
Application Number : 67648
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Tabrecta
Dosage Form : Film Coated Tablet
Dosage Strength : 200mg
Packaging :
Approval Date : 26/04/2021
Application Number : 67648
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Authorized
Registration Country : Spain
Capmatinib Dihydrochloride Monohydrate
Brand Name : Table
Dosage Form : Film Coated Tablet
Dosage Strength : 150MG
Packaging :
Approval Date : 2022-07-12
Application Number : 1221650002
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Capmatinib Dihydrochloride Monohydrate
Brand Name : Table
Dosage Form : Film Coated Tablet
Dosage Strength : 200MG
Packaging :
Approval Date : 2022-07-12
Application Number : 1221650004
Regulatory Info : Authorized
Registration Country : Spain