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    01 1Zaklady Farmaceutyczne Polpharma SA

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    Zaklady Farmaceutyczne Polpharma SA

    Poland
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    The Benjamin Royal Sonesta
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    Virtual BoothEuropean CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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    Regulatory Info : Approved

    Registration Country : Sweden

    Indacaterol; Glycopyrronium

    Brand Name : Indacaterol/Glycopyrronium Polpharma

    Dosage Form : Capsule For Inhalation

    Dosage Strength : 85mcg; 43mcg

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    Approval Date : 15-09-2025

    Application Number : 2.02E+13

    Regulatory Info : Approved

    Registration Country : Sweden

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    02

    Novartis Europharm Limited

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    Regulatory Info : Marketed

    Registration Country : Norway

    Indacaterol maleate

    Brand Name : Onbrez Breezhaler

    Dosage Form : Capsule For Inhalation

    Dosage Strength : 150mcg

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    Registration Country : Norway

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    03

    Novartis Europharm Limited

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    Regulatory Info : Not Marketed

    Registration Country : Norway

    Indacaterol maleate

    Brand Name : Onbrez Breezhaler

    Dosage Form : Capsule For Inhalation

    Dosage Strength : 150mcg

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    Regulatory Info : Not Marketed

    Registration Country : Norway

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    Novartis Europharm Limited

    Switzerland
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    Regulatory Info : Marketed

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    Indacaterol maleate

    Brand Name : Onbrez Breezhaler

    Dosage Form : Capsule For Inhalation

    Dosage Strength : 300mcg

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    Regulatory Info : Marketed

    Registration Country : Norway

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    05

    Novartis Europharm Limited

    Switzerland
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    Regulatory Info : Prescription

    Registration Country : Estonia

    Indacaterol; Glycopyrronium; Mometasone

    Brand Name : Enerzair Breezhaler

    Dosage Form : Inhalation Powder Hard Capsule

    Dosage Strength : 114mcg; 46mcg; 136mcg

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    Registration Country : Estonia

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    06

    Novartis Europharm Limited

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    Regulatory Info : Prescription

    Registration Country : Estonia

    Indacaterol; Glycopyrronium; Mometasone

    Brand Name : Zimbus Breezhaler

    Dosage Form : Inhalation Powder Hard Capsule

    Dosage Strength : 114mcg/dose; 46mcg/dose

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    Registration Country : Estonia

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    07

    Novartis Europharm Limited

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    Regulatory Info : Prescription

    Registration Country : Estonia

    Indacaterol; Mometasone Furoate

    Brand Name : Atectura Breezhaler

    Dosage Form : Inhalation Powder Hard Capsule

    Dosage Strength : 125mcg; 1275mcg

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    Registration Country : Estonia

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    08

    Novartis Europharm Limited

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    Registration Country : Estonia

    Indacaterol; Mometasone Furoate

    Brand Name : Bemrist Breezhaler

    Dosage Form : Inhalation Powder Hard Capsule

    Dosage Strength : 125mcg; 1275mcg

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    Registration Country : Estonia

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    09

    Novartis Europharm Limited

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    Regulatory Info : Prescription

    Registration Country : Estonia

    Indacaterol; Mometasone Furoate

    Brand Name : Atectura Breezhaler

    Dosage Form : Inhalation Powder Hard Capsule

    Dosage Strength : 125mcg; 260mcg

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    Approval Date :

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    Regulatory Info : Prescription

    Registration Country : Estonia

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    10

    Novartis Europharm Limited

    Switzerland
    BioAsia
    Not Confirmed
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    Novartis Europharm Limited

    Switzerland
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    BioAsia
    Not Confirmed
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    Regulatory Info : Prescription

    Registration Country : Estonia

    Indacaterol; Mometasone Furoate

    Brand Name : Bemrist Breezhaler

    Dosage Form : Inhalation Powder Hard Capsule

    Dosage Strength : 125mcg; 260mcg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Prescription

    Registration Country : Estonia

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