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01 2Centocor

02 23Janssen-Cilag

03 3Micro Labs Limited

04 1Teva Pharmaceutical Industries

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PharmaCompass

01

SCOPE Summit
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SCOPE Summit
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DARUNAVIR (DARUNAVIR ETHANOLATE)

Brand Name : PREZCOBIX

Dosage Form : TABLET

Dosage Strength : 800MG

Packaging : 30

Approval Date :

Application Number : 2426501

Regulatory Info : Prescription

Registration Country : Canada

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02

SCOPE Summit
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SCOPE Summit
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DARUNAVIR (DARUNAVIR ETHANOLATE)

Brand Name : SYMTUZA

Dosage Form : TABLET

Dosage Strength : 800MG

Packaging : 30

Approval Date :

Application Number : 2473720

Regulatory Info : Prescription

Registration Country : Canada

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03

SCOPE Summit
Not Confirmed
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SCOPE Summit
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Darunavir Ethanolate; Emtricitabine; Cobicistat; Tenofovir Alafenamide Hemifumarate

Brand Name : Symtuza

Dosage Form : Film Coated Tablet

Dosage Strength : 800mg;150mg;200mg;10mg

Packaging :

Approval Date : 21/09/2017

Application Number : 20160915000046

Regulatory Info : Approved

Registration Country : Sweden

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04

SCOPE Summit
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SCOPE Summit
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Darunavir Ethanolate; Cobicistat

Brand Name : Rezolsta

Dosage Form : Film Coated Tablet

Dosage Strength : 800mg;150mg

Packaging :

Approval Date : 19/11/2014

Application Number : 20131031000074

Regulatory Info : Approved

Registration Country : Sweden

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05

SCOPE Summit
Not Confirmed
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SCOPE Summit
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Darunaviretanolat

Brand Name : Prezista

Dosage Form : Film Coated Tablet

Dosage Strength : 400mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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06

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Darunaviretanolat

Brand Name : Prezista

Dosage Form : Film Coated Tablet

Dosage Strength : 600mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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07

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Darunaviretanolat

Brand Name : Prezista

Dosage Form : Film Coated Tablet

Dosage Strength : 800mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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08

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Darunaviretanolat; Kobicistat

Brand Name : Rezolsta

Dosage Form : Film Coated Tablet

Dosage Strength : 800mg; 150mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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09

SCOPE Summit
Not Confirmed
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SCOPE Summit
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Darunaviretanolat; Kobicistat; Emtricitabin; Tenofoviralafenamidfumarat

Brand Name : Symtuza

Dosage Form : Tablet

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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10

SCOPE Summit
Not Confirmed
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SCOPE Summit
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Emtricitabine; Darunavir Ethanolate; Cobicistat; Tenofovir Alafenamide Fumarate

Brand Name : Symtuza

Dosage Form : Film Coated Tablet

Dosage Strength : 800MG; 150MG; 200MG; 10 MG

Packaging :

Approval Date : 02-11-2021

Application Number : 1171225001IP

Regulatory Info : Authorized

Registration Country : Spain

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11

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Emtricitabine; Darunavir Ethanolate; Cobicistat; Tenofovir Alafenamide Fumarate

Brand Name : Symtuza

Dosage Form : Film Coated Tablet

Dosage Strength : 800MG; 150MG; 200MG; 10 MG

Packaging :

Approval Date : 27-10-2017

Application Number : 1171225001

Regulatory Info : Authorized

Registration Country : Spain

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12

SCOPE Summit
Not Confirmed
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SCOPE Summit
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Darunavir Ethanolate; Cobicistat

Brand Name : Rezolsta

Dosage Form : Film Coated Tablet

Dosage Strength : 800MG; 150 MG

Packaging :

Approval Date : 26-12-2014

Application Number : 114967001

Regulatory Info : Authorized

Registration Country : Spain

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13

SCOPE Summit
Not Confirmed
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SCOPE Summit
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Darunavir Ethanolate

Brand Name : Prezista

Dosage Form : Film Coated Tablet

Dosage Strength : 400MG

Packaging :

Approval Date : 16-02-2009

Application Number : 6380003

Regulatory Info : Authorized

Registration Country : Spain

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14

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Darunavir Ethanolate

Brand Name : Prezista

Dosage Form : Film Coated Tablet

Dosage Strength : 800MG

Packaging :

Approval Date : 20-02-2013

Application Number : 106380007

Regulatory Info : Authorized

Registration Country : Spain

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15

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Darunavir Ethanolate

Brand Name : Prezista

Dosage Form : Film Coated Tablet

Dosage Strength : 600MG

Packaging :

Approval Date : 16-02-2009

Application Number : 6380002

Regulatory Info : Authorized

Registration Country : Spain

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16

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Darunavir Ethanolate

Brand Name : Prezista

Dosage Form : Film Coated Tablet

Dosage Strength : 300MG

Packaging :

Approval Date : 07-03-2007

Application Number : 6380001

Regulatory Info : Cancelled

Registration Country : Spain

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17

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Darunavir Ethanolate

Brand Name : Prezista

Dosage Form : Oral Suspension

Dosage Strength : 100MG

Packaging :

Approval Date : 01-02-2013

Application Number : 106380006

Regulatory Info : Authorized

Registration Country : Spain

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18

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

DARUNAVIR ETHANOLATE

Brand Name : DARUNAVIR ETHANOLATE

Dosage Form : TABLET;ORAL

Dosage Strength : 150MG

Packaging :

Approval Date :

Application Number : 210187

Regulatory Info :

Registration Country : USA

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19

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

DARUNAVIR ETHANOLATE

Brand Name : DARUNAVIR ETHANOLATE

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Packaging :

Approval Date :

Application Number : 210187

Regulatory Info :

Registration Country : USA

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20

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

DARUNAVIR ETHANOLATE

Brand Name : DARUNAVIR ETHANOLATE

Dosage Form : TABLET;ORAL

Dosage Strength : 600MG

Packaging :

Approval Date :

Application Number : 210187

Regulatory Info :

Registration Country : USA

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