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01 1CHEMO

02 1Farmaprojects S.A.U

03 2Novartis Pharmaceuticals Australia Pty Limited

04 17Novartis Pharmaceuticals Corporation

05 6Novartis South Africa (Pty) Ltd

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PharmaCompass

01

2024 ACI Convention
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Indacaterol; Glycopyrronium Bromide

Brand Name :

Dosage Form : Capsule - Powder for Inhalation

Dosage Strength : 85MCG; 43MCG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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02

2024 ACI Convention
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Indacaterol Maleate; Glycopyrronium Bromide

Brand Name :

Dosage Form : Inhalation Powder

Dosage Strength : 85; 43

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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03

2024 ACI Convention
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2024 ACI Convention
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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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04

2024 ACI Convention
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GLYCOPYRROLATE; INDACATEROL MALEATE

Brand Name : UTIBRON

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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05

2024 ACI Convention
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2024 ACI Convention
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Indacaterol

Brand Name : Onbrez Breezhaler

Dosage Form : Inh Caps

Dosage Strength : 0.15mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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06

2024 ACI Convention
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2024 ACI Convention
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Indacaterol

Brand Name : Onbrez Breezhaler

Dosage Form : Inh Caps

Dosage Strength : 0.3mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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07

2024 ACI Convention
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2024 ACI Convention
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Indacaterol

Brand Name : Onbrez Breezhaler

Dosage Form : Inh Caps

Dosage Strength : 0.15mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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08

2024 ACI Convention
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2024 ACI Convention
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Indacaterol

Brand Name : Onbrez Breezhaler

Dosage Form : Inh Caps

Dosage Strength : 0.3mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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09

2024 ACI Convention
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2024 ACI Convention
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Indacaterol; Mometasone-17 furoase

Brand Name : Atectura Breezhaler

Dosage Form : Inh Kaps

Dosage Strength : 150mcg/160mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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10

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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Indacaterol; Mometasone-17 furoase

Brand Name : Atectura Breezhaler

Dosage Form : Inh Kaps

Dosage Strength : 150mcg/160mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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11

2024 ACI Convention
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2024 ACI Convention
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Indacaterol; Mometasone-17 furoase

Brand Name : Atectura Breezhaler

Dosage Form : Inh Kaps

Dosage Strength : 150mcg/320mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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12

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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Indacaterol; Mometasone-17 furoase

Brand Name : Atectura Breezhaler

Dosage Form : Inh Kaps

Dosage Strength : 150mcg/320mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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13

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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Indacaterol; Mometasone-17 furoase

Brand Name : Atectura Breezhaler

Dosage Form : Inh Kaps

Dosage Strength : 150mcg/80mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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14

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
Not Confirmed

Indacaterol; Mometasone-17 furoase

Brand Name : Atectura Breezhaler

Dosage Form : Inh Kaps

Dosage Strength : 150mcg/80mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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15

2024 ACI Convention
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2024 ACI Convention
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Indacaterolum; Glycopyrronium

Brand Name : Ultibro Breezhaler

Dosage Form : Inh Caps

Dosage Strength : 110mcg/50mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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16

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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Indacaterolum; Glycopyrronium

Brand Name : Ultibro Breezhaler

Dosage Form : Inh Caps

Dosage Strength : 110mcg/50mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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17

2024 ACI Convention
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2024 ACI Convention
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Indacaterolum; Glycopyrronium; Mometasoni-17 furoas

Brand Name : Enerzair Breezhaler Inha

Dosage Form : Inh Caps

Dosage Strength : 150/50/160Mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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18

2024 ACI Convention
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2024 ACI Convention
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Indacaterolum; Glycopyrronium; Mometasoni-17 furoas

Brand Name : Enerzair Breezhaler Inha

Dosage Form : Inh Caps

Dosage Strength : 150/50/160Mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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19

2024 ACI Convention
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2024 ACI Convention
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Indacaterolum; Glycopyrronium; Mometasoni-17 furoas

Brand Name : Enerzair Breezhaler Inha+Sens

Dosage Form : Inh Caps

Dosage Strength : 150/50/160Mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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20

Novartis South Africa (Pty) Ltd

Country
2024 ACI Convention
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Novartis South Africa (Pty) Ltd

Country
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2024 ACI Convention
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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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