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01 1F. Hoffmann-La Roche, Ltd.

02 1ROCHE REGISTRATION LTD

03 1Roche Pharma (Switzerland) Ag

04 1Roche Registration GmbH

05 3Roche Registration Gmbh

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PharmaCompass

01

IPPE
Not Confirmed
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IPPE
Not Confirmed

cobimetinib

Brand Name : Cotellic

Dosage Form : Cobimetinib 20Mg 63 Combined Oral Use

Dosage Strength : 3x21 cpr riv 20 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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02

IPPE
Not Confirmed
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IPPE
Not Confirmed

Cobimetinub

Brand Name : Cotellic

Dosage Form : Film Coated Tablet

Dosage Strength : 20mg

Packaging :

Approval Date : 24/08/2015

Application Number : 65620

Regulatory Info : Allowed

Registration Country : Switzerland

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03

IPPE
Not Confirmed
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IPPE
Not Confirmed

Kobimetinibhemifumarat

Brand Name : Cotellic

Dosage Form : Film Coated Tablet

Dosage Strength : 20mg

Packaging :

Approval Date : 20/11/2015

Application Number : 20140904000011

Regulatory Info : Approved

Registration Country : Sweden

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04

IPPE
Not Confirmed
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IPPE
Not Confirmed

Cobimetinib

Brand Name : Cotellic®

Dosage Form : Film Coated Tablet

Dosage Strength : 20mg

Packaging :

Approval Date : 06-05-2022

Application Number :

Regulatory Info :

Registration Country : Moldova

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05

IPPE
Not Confirmed
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IPPE
Not Confirmed

Cobimetinib hemifumarate

Brand Name : Cotellic

Dosage Form : Film Coated Tablet

Dosage Strength : 20mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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06

IPPE
Not Confirmed
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IPPE
Not Confirmed

Cobimetinib

Brand Name : Cotellic

Dosage Form : Film-Coated Tablet

Dosage Strength : 20mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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07

IPPE
Not Confirmed
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IPPE
Not Confirmed

Cobimetinib

Brand Name : Cotellic

Dosage Form : Film Coated Tablet

Dosage Strength : 20MG

Packaging :

Approval Date : 16-12-2015

Application Number : 1151048001

Regulatory Info : Authorized

Registration Country : Spain

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