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List of All Manufacturers & Suppliers of Entrectinib Licensing, EU CTD Dossiers, Marketing Authorizations, Finished Dosage Formulations listed on PharmaCompass.com

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01 7F. Hoffmann-La Roche

02 5Genentech

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01

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Entrectinibum

Brand Name : Rozlytrek

Dosage Form : Kaps

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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02

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Entrectinibum

Brand Name : Rozlytrek

Dosage Form : Kaps

Dosage Strength : 200mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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03

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ENTRECTINIB

Brand Name : ROZLYTREK

Dosage Form : CAPSULE

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number : 2495015

Regulatory Info : Prescription

Registration Country : Canada

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04

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ENTRECTINIB

Brand Name : ROZLYTREK

Dosage Form : CAPSULE

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 2495007

Regulatory Info : Prescription

Registration Country : Canada

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05

Luxepack
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Entrectinib

Brand Name : Rozlytrek 100mg

Dosage Form : CAP

Dosage Strength : 100MG

Packaging : 1X30MG

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

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Entrectinib

Brand Name : Rozlytrek 200mg

Dosage Form : CAP

Dosage Strength : 200MG

Packaging : 1X90MG

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

Luxepack
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entrectinib

Brand Name : Rozlytrek

Dosage Form :

Dosage Strength :

Packaging : 90

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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08

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ENTRECTINIB

Brand Name : ROZLYTREK

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Packaging :

Approval Date : 2019-08-15

Application Number : 212725

Regulatory Info : RX

Registration Country : USA

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09

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ENTRECTINIB

Brand Name : ROZLYTREK

Dosage Form : CAPSULE;ORAL

Dosage Strength : 200MG

Packaging :

Approval Date : 2019-08-15

Application Number : 212725

Regulatory Info : RX

Registration Country : USA

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10

Luxepack
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Luxepack
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ENTRECTINIB

Brand Name : ROZLYTREK

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 212726

Regulatory Info :

Registration Country : USA

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11

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ENTRECTINIB

Brand Name : ROZLYTREK

Dosage Form : CAPSULE;ORAL

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number : 212726

Regulatory Info :

Registration Country : USA

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12

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ENTRECTINIB

Brand Name : ROZLYTREK

Dosage Form : PELLETS;ORAL

Dosage Strength : 50MG/PACKET

Packaging :

Approval Date : 2023-10-20

Application Number : 218550

Regulatory Info : RX

Registration Country : USA

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