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01 16F. Hoffmann-La Roche

02 5Genentech

03 3Roche Diagnostics GmbH

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PharmaCompass

01

RNA Leaders Europe
Not Confirmed
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RNA Leaders 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

RNA Leaders Europe
Not Confirmed
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RNA Leaders 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

RNA Leaders Europe
Not Confirmed
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RNA Leaders 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

RNA Leaders Europe
Not Confirmed
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RNA Leaders 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

RNA Leaders Europe
Not Confirmed
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RNA Leaders 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

RNA Leaders Europe
Not Confirmed
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RNA Leaders 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

RNA Leaders Europe
Not Confirmed
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RNA Leaders 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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08

RNA Leaders Europe
Not Confirmed
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RNA Leaders Europe
Not Confirmed

Entrectinib

Brand Name : Rozlytrek

Dosage Form : Hard Capsules

Dosage Strength : 200mg

Packaging :

Approval Date : 03-08-2020

Application Number : 28106220219

Regulatory Info : Prescription

Registration Country : Denmark

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09

RNA Leaders Europe
Not Confirmed
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RNA Leaders Europe
Not Confirmed

Entrektinib

Brand Name : Rozlytrek

Dosage Form : Capsule

Dosage Strength : 100mg

Packaging :

Approval Date : 31-07-2020

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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10

RNA Leaders Europe
Not Confirmed
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RNA Leaders Europe
Not Confirmed

Entrektinib

Brand Name : Rozlytrek

Dosage Form : Capsule

Dosage Strength : 200mg

Packaging :

Approval Date : 31-07-2020

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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11

RNA Leaders Europe
Not Confirmed
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RNA Leaders Europe
Not Confirmed

Entrektinib

Brand Name : Rozlytrek

Dosage Form : Granules

Dosage Strength : 50mg

Packaging :

Approval Date : 28-06-2024

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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12

RNA Leaders Europe
Not Confirmed
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RNA Leaders 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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13

RNA Leaders Europe
Not Confirmed
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RNA Leaders 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

RNA Leaders Europe
Not Confirmed
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RNA Leaders 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

RNA Leaders Europe
Not Confirmed
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RNA Leaders 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

RNA Leaders Europe
Not Confirmed
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RNA Leaders 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

RNA Leaders Europe
Not Confirmed
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RNA Leaders 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

RNA Leaders Europe
Not Confirmed
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RNA Leaders 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

RNA Leaders Europe
Not Confirmed
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RNA Leaders 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

RNA Leaders Europe
Not Confirmed
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RNA Leaders 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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