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01 3MIRDAMETINIB
02 6Mirdametinib
03 3NIROGACESTAT HYDROBROMIDE
04 3Nirogacestat
05 2Nirogacestat Hydrobromide
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01 6SPRINGWORKS
02 11Springworks Therapeutics Ireland Limited
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01 2CAPSULE;ORAL
02 4Capsule
03 2Dispersible Tablet
04 5Film Coated Tablet
05 1TABLET, FOR SUSPENSION;ORAL
06 3TABLET;ORAL
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01 1100MG
02 1100mg
03 1150MG
04 1150mg
05 21MG
06 41mg
07 12MG
08 22mg
09 150mg
10 1EQ 100MG BASE
11 1EQ 150MG BASE
12 1EQ 50MG BASE
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01 3Estonia
02 2Spain
03 6Sweden
04 6USA
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Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET, FOR SUSPENSION;O...
Brand Name : GOMEKLI
Dosage Strength : 1MG
Packaging :
Approval Date : 2025-02-11
Application Number : 219379
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : CAPSULE;ORAL
Brand Name : GOMEKLI
Dosage Strength : 1MG
Packaging :
Approval Date : 2025-02-11
Application Number : 219389
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : CAPSULE;ORAL
Brand Name : GOMEKLI
Dosage Strength : 2MG
Packaging :
Approval Date : 2025-02-11
Application Number : 219389
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : Prescription
Registration Country : Estonia
Dosage Form : Capsule
Brand Name : Ezmekly
Dosage Strength : 1mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia

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Regulatory Info : Prescription
Registration Country : Estonia
Dosage Form : Dispersible Tablet
Brand Name : Ezmekly
Dosage Strength : 1mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia

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Regulatory Info : Prescription
Registration Country : Estonia
Dosage Form : Capsule
Brand Name : Ezmekly
Dosage Strength : 2mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia

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Regulatory Info : Approved
Registration Country : Sweden
Dosage Form : Dispersible Tablet
Brand Name : Ezmekly
Dosage Strength : 1mg
Packaging :
Approval Date : 17-07-2025
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Dosage Form : Capsule
Brand Name : Ezmekly
Dosage Strength : 1mg
Packaging :
Approval Date : 17-07-2025
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Dosage Form : Capsule
Brand Name : Ezmekly
Dosage Strength : 2mg
Packaging :
Approval Date : 17-07-2025
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Brand Name : Ogsiveo
Dosage Strength : 100mg
Packaging :
Approval Date : 14-08-2025
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
