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01 27Novartis Europharm Limited

02 7Novartis Pharma Schweiz Ag

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PharmaCompass

01

Organic Process R&D
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Organic Process R&D
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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

PackExpo
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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

PackExpo
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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

PackExpo
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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

PackExpo
Not Confirmed
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PackExpo
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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

PackExpo
Not Confirmed
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PackExpo
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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

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

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

PackExpo
Not Confirmed
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PackExpo
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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

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

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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10

PackExpo
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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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