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01 1EMD Serono
02 3Merck & Co
03 1Merck Group
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01 3Film Coated Tablet
02 1TABLET;ORAL
03 1Blank
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01 1Allowed
02 1Approved
03 1Authorized
04 1RX
05 1Blank
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01 1TEPMETKO
02 4Tepmetko
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01 1Australia
02 1Spain
03 1Sweden
04 1Switzerland
05 1USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TEPMETKO
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 225MG BASE
Packaging :
Approval Date : 2021-02-03
Application Number : 214096
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Tepotinib Hydrochloride Monohydrate
Brand Name : Tepmetko
Dosage Form : Film Coated Tablet
Dosage Strength : 225mg
Packaging :
Approval Date : 16/02/2022
Application Number : 20201106000046
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info :
Registration Country : Australia
Brand Name : Tepmetko
Dosage Form :
Dosage Strength :
Packaging : 60
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : Authorized
Registration Country : Spain
Tepotinib Hydrochloride Monohydrate
Brand Name : Tepmetko
Dosage Form : Film Coated Tablet
Dosage Strength : 225MG
Packaging :
Approval Date : 2022-03-31
Application Number : 1211596001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Tepmetko
Dosage Form : Film Coated Tablet
Dosage Strength : 225mg
Packaging :
Approval Date : 22/06/2021
Application Number : 68113
Regulatory Info : Allowed
Registration Country : Switzerland