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01 4Novartis Pharmaceuticals Australia Pty Limited

02 36Novartis Pharmaceuticals Corporation

03 6Novartis South Africa (Pty) Ltd

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PharmaCompass

01

Luxepack
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INDACATEROL MALEATE

Brand Name : ARCAPTA NEOHALER

Dosage Form : POWDER;INHALATION

Dosage Strength : EQ 75MCG BASE

Packaging :

Approval Date : 2011-07-01

Application Number : 22383

Regulatory Info : DISCN

Registration Country : USA

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02

Luxepack
Not Confirmed
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GLYCOPYRROLATE; INDACATEROL MALEATE

Brand Name : UTIBRON NEOHALER

Dosage Form : POWDER;INHALATION

Dosage Strength : 15.6MCG/INH;27.5MCG/INH

Packaging :

Approval Date : 2015-10-29

Application Number : 207930

Regulatory Info : DISCN

Registration Country : USA

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03

Luxepack
Not Confirmed
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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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04

Luxepack
Not Confirmed
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Luxepack
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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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05

Luxepack
Not Confirmed
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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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06

Luxepack
Not Confirmed
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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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07

Luxepack
Not Confirmed
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Luxepack
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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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08

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

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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09

Luxepack
Not Confirmed
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Luxepack
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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10

Luxepack
Not Confirmed
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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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11

Luxepack
Not Confirmed
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Luxepack
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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12

Luxepack
Not Confirmed
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Luxepack
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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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13

Luxepack
Not Confirmed
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Indacaterol; Glycopyrronium; Mometasone Furose

Brand Name : Enerzair Breezhaler ?g

Dosage Form : Capsule For Inhalation

Dosage Strength : 150mcg;50mcg;160mcg

Packaging :

Approval Date : 24/09/2020

Application Number : 67596

Regulatory Info : Allowed

Registration Country : Switzerland

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14

Luxepack
Not Confirmed
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Indacaterol; Mometasone Furoate

Brand Name : Atectura Breezhaler ?g

Dosage Form : Capsule For Inhalation

Dosage Strength : 150mcg;80mcg

Packaging :

Approval Date : 10/09/2020

Application Number : 67597

Regulatory Info : Allowed

Registration Country : Switzerland

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15

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

Indacaterol; Mometasone Furoate

Brand Name : Atectura Breezhaler ?g

Dosage Form : Capsule For Inhalation

Dosage Strength : 150mcg;160mcg

Packaging :

Approval Date : 10/09/2020

Application Number : 67597

Regulatory Info : Allowed

Registration Country : Switzerland

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16

Luxepack
Not Confirmed
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Indacaterol; Mometasone Furoate

Brand Name : Atectura Breezhaler ?g

Dosage Form : Capsule For Inhalation

Dosage Strength : 150mcg;320mcg

Packaging :

Approval Date : 10/09/2020

Application Number : 67597

Regulatory Info : Allowed

Registration Country : Switzerland

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17

Luxepack
Not Confirmed
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Indigo

Brand Name : Onbrez Breezhaler

Dosage Form : Capsule For Inhalation

Dosage Strength : 150mcg

Packaging :

Approval Date : 21/05/2010

Application Number : 60141

Regulatory Info : Allowed

Registration Country : Switzerland

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18

Luxepack
Not Confirmed
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Indigo

Brand Name : Onbrez Breezhaler

Dosage Form : Capsule For Inhalation

Dosage Strength : 300mcg

Packaging :

Approval Date : 21/05/2010

Application Number : 60141

Regulatory Info : Allowed

Registration Country : Switzerland

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19

Novartis South Africa (Pty) Ltd

Country
Luxepack
Not Confirmed
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Novartis South Africa (Pty) Ltd

Country
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Luxepack
Not Confirmed

Indacaterol

Brand Name : Bemrist Breezhaler 150/80

Dosage Form : CPS

Dosage Strength : 150mcg

Packaging : 30X1mcg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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20

Novartis South Africa (Pty) Ltd

Country
Luxepack
Not Confirmed
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Novartis South Africa (Pty) Ltd

Country
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Luxepack
Not Confirmed

Indacaterol

Brand Name : Bemrist Breezhaler 150/160

Dosage Form : CPS

Dosage Strength : 150mcg

Packaging : 30X1mcg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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