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    Approved Marketing Authorisations (MA) containing Umeclidinium in Europe. Original Data : EMA Website

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    Umeclidinium

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    01 3GLAXO GROUP LTD UK

    02 2Glaxo Group Ltd - Brentford

    03 1Glaxo Group Ltd,

    04 6GlaxoSmithKline AG

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    01

    Glaxo Group Ltd,

    United Kingdom
    AAPS 2024
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    Glaxo Group Ltd,

    United Kingdom
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    Regulatory Info :

    Registration Country : Sweden

    umeklidiniumbromid

    Brand Name : Incruse

    Dosage Form : INHALATION POWDER, PRE-DISPENSED

    Dosage Strength : 55 MICROGRAMS

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    02

    GLAXO GROUP LTD UK

    United Kingdom
    AAPS 2024
    Not Confirmed
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    GLAXO GROUP LTD UK

    United Kingdom
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    Regulatory Info :

    Registration Country : Italy

    Umeclidinium Bromide

    Brand Name : Incruse

    Dosage Form : Umeclidinio 55Mcg 30 Joined' Respiratory Use

    Dosage Strength : 30 doses inhalation groun 55 mcg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    03

    GLAXO GROUP LTD UK

    United Kingdom
    AAPS 2024
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    GLAXO GROUP LTD UK

    United Kingdom
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    Regulatory Info :

    Registration Country : Italy

    Umeclidinium Bromide; vilanterol

    Brand Name : Rcv

    Dosage Form : Umeclidinio+Vilanterolo 55Mcg+22Mcg 30 Joined' Respiratory Use

    Dosage Strength : 30 doses groun inhal 55 mcg + 22 mcg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    04

    GLAXO GROUP LTD UK

    United Kingdom
    AAPS 2024
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    GLAXO GROUP LTD UK

    United Kingdom
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    Regulatory Info :

    Registration Country : Italy

    Umeclidinium Bromide; vilanterol

    Brand Name : Laventair

    Dosage Form : Umeclidinio+Vilanterolo 55Mcg+22Mcg 30 Joined' Respiratory Use

    Dosage Strength : 30 doses groun inhal 55 mcg + 22 mcg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    05

    Glaxo Group Ltd - Brentford

    United Kingdom
    AAPS 2024
    Not Confirmed
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    United Kingdom
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    Regulatory Info :

    Registration Country : Norway

    Umeclidinium Bromide

    Brand Name : Incruse

    Dosage Form : Inhalasjonspulver, dose dispensed

    Dosage Strength : 55 mcg

    Packaging : Blister

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    06

    Glaxo Group Ltd - Brentford

    United Kingdom
    AAPS 2024
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    United Kingdom
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    Regulatory Info :

    Registration Country : Norway

    Umeclidinium Bromide

    Brand Name : Incruse

    Dosage Form : Inhalasjonspulver, dose dispensed

    Dosage Strength : 55 mcg

    Packaging : Blister

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    07

    GlaxoSmithKline AG

    United Kingdom
    AAPS 2024
    Not Confirmed
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    GlaxoSmithKline AG

    United Kingdom
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    AAPS 2024
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    Regulatory Info :

    Registration Country : Switzerland

    Fluticasoni furoas; Umeclidinium; Vilanterolum

    Brand Name : Trelegy Ellipta

    Dosage Form : Inh Plv

    Dosage Strength : 92/55/22Mcg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    08

    GlaxoSmithKline AG

    United Kingdom
    AAPS 2024
    Not Confirmed
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    GlaxoSmithKline AG

    United Kingdom
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    AAPS 2024
    Not Confirmed
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    Regulatory Info :

    Registration Country : Switzerland

    Fluticasoni furoas; Umeclidinium; Vilanterolum

    Brand Name : Trelegy Ellipta

    Dosage Form : Inh Plv

    Dosage Strength : 92/55/22Mcg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    09

    GlaxoSmithKline AG

    United Kingdom
    AAPS 2024
    Not Confirmed
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    GlaxoSmithKline AG

    United Kingdom
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    AAPS 2024
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    Regulatory Info :

    Registration Country : Switzerland

    Umeclidinium

    Brand Name : Incruse Ellipta

    Dosage Form : Inh Plv

    Dosage Strength : 55mcg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    10

    GlaxoSmithKline AG

    United Kingdom
    AAPS 2024
    Not Confirmed
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    GlaxoSmithKline AG

    United Kingdom
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    AAPS 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info :

    Registration Country : Switzerland

    Umeclidinium

    Brand Name : Incruse Ellipta

    Dosage Form : Inh Plv

    Dosage Strength : 55mcg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

    blank

    Portfolio PDF

    Product Web Link

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    Website

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