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01 8Amgen Inc

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PharmaCompass

01

FNCE
Not Confirmed
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FNCE
Not Confirmed

SOTORASIB

Brand Name : LUMAKRAS

Dosage Form : TABLET;ORAL

Dosage Strength : 120MG

Packaging :

Approval Date : 2021-05-28

Application Number : 214665

Regulatory Info : RX

Registration Country : USA

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02

FNCE
Not Confirmed
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FNCE
Not Confirmed

SOTORASIB

Brand Name : LUMAKRAS

Dosage Form : TABLET;ORAL

Dosage Strength : 320MG

Packaging :

Approval Date : 2023-01-20

Application Number : 214665

Regulatory Info : RX

Registration Country : USA

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03

FNCE
Not Confirmed
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FNCE
Not Confirmed

SOTORASIB

Brand Name : LUMAKRAS

Dosage Form : TABLET;ORAL

Dosage Strength : 240MG

Packaging :

Approval Date : 2024-06-26

Application Number : 214665

Regulatory Info : RX

Registration Country : USA

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04

FNCE
Not Confirmed
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FNCE
Not Confirmed

Sotorasib

Brand Name : Lumycrase

Dosage Form : Film Coated Tablet

Dosage Strength : 120mg

Packaging :

Approval Date : 06/01/2022

Application Number : 20201221000013

Regulatory Info : Approved

Registration Country : Sweden

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05

FNCE
Not Confirmed
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FNCE
Not Confirmed

Sotorasib

Brand Name : Lumycrase

Dosage Form : Film Coated Tablet

Dosage Strength : 240mg

Packaging :

Approval Date : 16/05/2024

Application Number : 20230207000136

Regulatory Info : Approved

Registration Country : Sweden

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06

FNCE
Not Confirmed
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FNCE
Not Confirmed

SOTORASIB

Brand Name : LUMAKRAS

Dosage Form : TABLET

Dosage Strength : 120MG

Packaging :

Approval Date :

Application Number : 2520095

Regulatory Info : Prescription

Registration Country : Canada

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07

FNCE
Not Confirmed
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FNCE
Not Confirmed

Sotorasib

Brand Name : Lumykras

Dosage Form : Film Coated Tablet

Dosage Strength : 240MG

Packaging :

Approval Date : 2024-05-23

Application Number : 1211603004

Regulatory Info : Authorized

Registration Country : Spain

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08

FNCE
Not Confirmed
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FNCE
Not Confirmed

Sotorasib

Brand Name : Lumykras

Dosage Form : Film Coated Tablet

Dosage Strength : 120MG

Packaging :

Approval Date : 2022-05-11

Application Number : 1211603001

Regulatory Info : Authorized

Registration Country : Spain

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