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01 16F. Hoffmann-La Roche

02 5Genentech

03 3Roche Diagnostics GmbH

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PharmaCompass

01

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

Entwined

Brand Name : Rozlytrek

Dosage Form : Hard Capsule

Dosage Strength : 100mg

Packaging :

Approval Date : 05/11/2020

Application Number : 67280

Regulatory Info : Allowed

Registration Country : Switzerland

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02

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

Entwined

Brand Name : Rozlytrek

Dosage Form : Hard Capsule

Dosage Strength : 200mg

Packaging :

Approval Date : 05/11/2020

Application Number : 67280

Regulatory Info : Allowed

Registration Country : Switzerland

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03

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

Entrectinib

Brand Name : Rozlytrek

Dosage Form : Capsule

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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04

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

Entrectinib

Brand Name : Rozlytrek

Dosage Form : Capsule

Dosage Strength : 200mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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05

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

Entrectinib

Brand Name : Rozlytrek

Dosage Form : Capsule

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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06

ESF Europe
Not Confirmed
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arrow
ESF Europe
Not Confirmed

Entrectinib

Brand Name : Rozlytrek

Dosage Form : Capsule

Dosage Strength : 200mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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07

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

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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08

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

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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09

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

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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10

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

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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11

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

Entrectinib

Brand Name : Rozlytrek

Dosage Form :

Dosage Strength :

Packaging : 90

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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12

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

Entrectinib

Brand Name : Rozlytrek

Dosage Form : Hard Capsules

Dosage Strength : 100mg

Packaging :

Approval Date : 03-08-2020

Application Number : 28106220119

Regulatory Info : Prescription

Registration Country : Denmark

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13

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

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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14

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

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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15

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

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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16

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

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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17

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

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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18

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

Entrectinib

Brand Name : Volume

Dosage Form : Film Coated Granule In Sachet

Dosage Strength : 50MG

Packaging :

Approval Date : 16-08-2024

Application Number : 1201460003

Regulatory Info : Authorized

Registration Country : Spain

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19

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

Entrectinib

Brand Name : Volume

Dosage Form : Hard Capsule

Dosage Strength : 100MG

Packaging :

Approval Date : 27-08-2020

Application Number : 1201460001

Regulatory Info : Authorized

Registration Country : Spain

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20

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

Entrectinib

Brand Name : Volume

Dosage Form : Hard Capsule

Dosage Strength : 200MG

Packaging :

Approval Date : 27-08-2020

Application Number : 1201460002

Regulatory Info : Authorized

Registration Country : Spain

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