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    Darunavir Ethanolate

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    01 8Janssen-Cilag International N.V.

    02 2Janssen-Cilag International Nv

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    01

    Janssen-Cilag International Nv

    Italy
    Fall Technical Meeting
    Not Confirmed
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    Janssen-Cilag International Nv

    Italy
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    Regulatory Info : Approved

    Registration Country : Sweden

    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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    02

    Janssen-Cilag International Nv

    Italy
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    Janssen-Cilag International Nv

    Italy
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    Fall Technical Meeting
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    Regulatory Info : Approved

    Registration Country : Sweden

    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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    03

    Janssen-Cilag International N.V.

    Italy
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    Italy
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    Regulatory Info : Authorized

    Registration Country : Spain

    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 : 2021-11-02

    Application Number : 1171225001IP

    Regulatory Info : Authorized

    Registration Country : Spain

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    04

    Janssen-Cilag International N.V.

    Italy
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    Janssen-Cilag International N.V.

    Italy
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    Fall Technical Meeting
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    Regulatory Info : Authorized

    Registration Country : Spain

    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 : 2017-10-27

    Application Number : 1171225001

    Regulatory Info : Authorized

    Registration Country : Spain

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    05

    Janssen-Cilag International N.V.

    Italy
    Fall Technical Meeting
    Not Confirmed
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    Janssen-Cilag International N.V.

    Italy
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    Fall Technical Meeting
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    Regulatory Info : Authorized

    Registration Country : Spain

    Darunavir Ethanolate; Cobicistat

    Brand Name : Rezolsta

    Dosage Form : Film Coated Tablet

    Dosage Strength : 800MG; 150 MG

    Packaging :

    Approval Date : 2014-12-26

    Application Number : 114967001

    Regulatory Info : Authorized

    Registration Country : Spain

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    06

    Janssen-Cilag International N.V.

    Italy
    Fall Technical Meeting
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    Janssen-Cilag International N.V.

    Italy
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    Fall Technical Meeting
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    Regulatory Info : Authorized

    Registration Country : Spain

    Darunavir Ethanolate

    Brand Name : Prezista

    Dosage Form : Film Coated Tablet

    Dosage Strength : 400MG

    Packaging :

    Approval Date : 2009-02-16

    Application Number : 06380003

    Regulatory Info : Authorized

    Registration Country : Spain

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    07

    Janssen-Cilag International N.V.

    Italy
    Fall Technical Meeting
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    Janssen-Cilag International N.V.

    Italy
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    Fall Technical Meeting
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    Regulatory Info : Authorized

    Registration Country : Spain

    Darunavir Ethanolate

    Brand Name : Prezista

    Dosage Form : Film Coated Tablet

    Dosage Strength : 800MG

    Packaging :

    Approval Date : 2013-02-20

    Application Number : 106380007

    Regulatory Info : Authorized

    Registration Country : Spain

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    08

    Janssen-Cilag International N.V.

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    Janssen-Cilag International N.V.

    Italy
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    Fall Technical Meeting
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    Regulatory Info : Authorized

    Registration Country : Spain

    Darunavir Ethanolate

    Brand Name : Prezista

    Dosage Form : Film Coated Tablet

    Dosage Strength : 600MG

    Packaging :

    Approval Date : 2009-02-16

    Application Number : 06380002

    Regulatory Info : Authorized

    Registration Country : Spain

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    09

    Janssen-Cilag International N.V.

    Italy
    Fall Technical Meeting
    Not Confirmed
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    Janssen-Cilag International N.V.

    Italy
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    Fall Technical Meeting
    Not Confirmed
    • fda
    • EDQM
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    Regulatory Info : Cancelled

    Registration Country : Spain

    Darunavir Ethanolate

    Brand Name : Prezista

    Dosage Form : Film Coated Tablet

    Dosage Strength : 300MG

    Packaging :

    Approval Date : 2007-03-07

    Application Number : 06380001

    Regulatory Info : Cancelled

    Registration Country : Spain

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    10

    Janssen-Cilag International N.V.

    Italy
    Fall Technical Meeting
    Not Confirmed
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    Janssen-Cilag International N.V.

    Italy
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    Fall Technical Meeting
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    • EDQM
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    Regulatory Info : Authorized

    Registration Country : Spain

    Darunavir Ethanolate

    Brand Name : Prezista

    Dosage Form : Oral Suspension

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 2013-02-01

    Application Number : 106380006

    Regulatory Info : Authorized

    Registration Country : Spain

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