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01 3MIRDAMETINIB
02 3Mirdametinib
03 3NIROGACESTAT HYDROBROMIDE
04 2Nirogacestat Hydrobromide
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01 6SPRINGWORKS
02 5Springworks Therapeutics Ireland Limited
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01 2CAPSULE;ORAL
02 2Capsule
03 1Dispersible Tablet
04 2Film Coated Tablet
05 1TABLET, FOR SUSPENSION;ORAL
06 3TABLET;ORAL
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01 1100MG
02 1150MG
03 21MG
04 21mg
05 12MG
06 12mg
07 1EQ 100MG BASE
08 1EQ 150MG BASE
09 1EQ 50MG BASE
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01 3Estonia
02 2Spain
03 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 : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : OGSIVEO
Dosage Strength : EQ 50MG BASE
Packaging :
Approval Date : 2023-11-27
Application Number : 217677
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : OGSIVEO
Dosage Strength : EQ 100MG BASE
Packaging :
Approval Date : 2024-04-04
Application Number : 217677
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : OGSIVEO
Dosage Strength : EQ 150MG BASE
Packaging :
Approval Date : 2024-04-04
Application Number : 217677
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : Authorized
Registration Country : Spain
Dosage Form : Film Coated Tablet
Brand Name : Ogsiveo
Dosage Strength : 100MG
Packaging :
Approval Date : 02-01-2026
Application Number : 1251932003
Regulatory Info : Authorized
Registration Country : Spain
