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    Indacaterol

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    01 27Novartis Europharm Limited

    02 7Novartis Pharma Schweiz Ag

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    01

    Novartis Europharm Limited

    Switzerland
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    Novartis Europharm Limited

    Switzerland
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    Regulatory Info : Approved

    Registration Country : Sweden

    Glycopyrronium Bromide; Indacaterol Maleate

    Brand Name : Ultibro Breezhaler

    Dosage Form : Capsule For Inhalation

    Dosage Strength : 85mcg/43mcg

    Packaging :

    Approval Date : 19/09/2013

    Application Number : 20121027000010

    Regulatory Info : Approved

    Registration Country : Sweden

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    02

    Novartis Europharm Limited

    Switzerland
    PREP
    Not Confirmed
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    Novartis Europharm Limited

    Switzerland
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    PREP
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Digital Content Digital Content

    Regulatory Info : Approved

    Registration Country : Sweden

    Glycopyrronium Bromide; Indacaterol Maleate

    Brand Name : Ultibro Breezhaler

    Dosage Form : Capsule For Inhalation

    Dosage Strength : 85mcg/43mcg

    Packaging :

    Approval Date : 23/04/2014

    Application Number : 20131218000026

    Regulatory Info : Approved

    Registration Country : Sweden

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    03

    Novartis Europharm Limited

    Switzerland
    PREP
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    Novartis Europharm Limited

    Switzerland
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Approved

    Registration Country : Sweden

    Glycopyrronium Bromide; Indacaterol Maleate

    Brand Name : Xoterna Breezhaler

    Dosage Form : Capsule For Inhalation

    Dosage Strength : 85mcg/43mcg

    Packaging :

    Approval Date : 19/09/2013

    Application Number : 20130406000053

    Regulatory Info : Approved

    Registration Country : Sweden

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    04

    Novartis Europharm Limited

    Switzerland
    PREP
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    Novartis Europharm Limited

    Switzerland
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Approved

    Registration Country : Sweden

    Indacaterol Maleate

    Brand Name : Onbrez Breezhaler

    Dosage Form : Capsule For Inhalation

    Dosage Strength : 150mcg

    Packaging :

    Approval Date : 30/11/2009

    Application Number : 20090910000072

    Regulatory Info : Approved

    Registration Country : Sweden

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    05

    Novartis Europharm Limited

    Switzerland
    PREP
    Not Confirmed
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    Novartis Europharm Limited

    Switzerland
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    PREP
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : Approved

    Registration Country : Sweden

    Indacaterol Maleate

    Brand Name : Onbrez Breezhaler

    Dosage Form : Capsule For Inhalation

    Dosage Strength : 300mcg

    Packaging :

    Approval Date : 30/11/2009

    Application Number : 20090910000089

    Regulatory Info : Approved

    Registration Country : Sweden

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    06

    Novartis Europharm Limited

    Switzerland
    PREP
    Not Confirmed
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    Novartis Europharm Limited

    Switzerland
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    PREP
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Virtual Booth Virtual Booth
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    Regulatory Info : Approved

    Registration Country : Sweden

    Indacaterol Maleate

    Brand Name : Onbrez Breezhaler

    Dosage Form : Capsule For Inhalation

    Dosage Strength : 150mcg

    Packaging :

    Approval Date : 30/11/2009

    Application Number : 20090206000106

    Regulatory Info : Approved

    Registration Country : Sweden

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    07

    Novartis Europharm Limited

    Switzerland
    PREP
    Not Confirmed
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    Novartis Europharm Limited

    Switzerland
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    PREP
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Virtual Booth Virtual Booth
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    Regulatory Info : Approved

    Registration Country : Sweden

    Indacaterol Maleate

    Brand Name : Onbrez Breezhaler

    Dosage Form : Capsule For Inhalation

    Dosage Strength : 300mcg

    Packaging :

    Approval Date : 30/11/2009

    Application Number : 20090207000013

    Regulatory Info : Approved

    Registration Country : Sweden

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    08

    Novartis Europharm Limited

    Switzerland
    PREP
    Not Confirmed
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    Novartis Europharm Limited

    Switzerland
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    PREP
    Not Confirmed
    • fda
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    • WHO-GMP
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    Regulatory Info : Approved

    Registration Country : Sweden

    Indacaterol Maleate

    Brand Name : Oslif Breezhaler

    Dosage Form : Capsule For Inhalation

    Dosage Strength : 150mcg

    Packaging :

    Approval Date : 30/11/2009

    Application Number : 20090910000058

    Regulatory Info : Approved

    Registration Country : Sweden

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    09

    Novartis Europharm Limited

    Switzerland
    PREP
    Not Confirmed
    arrow

    Novartis Europharm Limited

    Switzerland
    arrow
    PREP
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag Switzerland
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Approved

    Registration Country : Sweden

    Indacaterol Maleate

    Brand Name : Oslif Breezhaler

    Dosage Form : Capsule For Inhalation

    Dosage Strength : 300mcg

    Packaging :

    Approval Date : 30/11/2009

    Application Number : 20090910000065

    Regulatory Info : Approved

    Registration Country : Sweden

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    Portfolio PDF

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    10

    Novartis Pharma Schweiz Ag

    Switzerland
    PREP
    Not Confirmed
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    Novartis Pharma Schweiz Ag

    Switzerland
    arrow
    PREP
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag Switzerland
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Allowed

    Registration Country : Switzerland

    Indacaterol; Glycopyrronium

    Brand Name : Ultibro Breezhaler

    Dosage Form : Capsule For Inhalation

    Dosage Strength : 110mcg;50mcg

    Packaging :

    Approval Date : 10/07/2014

    Application Number : 63132

    Regulatory Info : Allowed

    Registration Country : Switzerland

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