01 1CHEMO
02 1Farmaprojects S.A.U
03 2Novartis Pharmaceuticals Australia Pty Limited
04 17Novartis Pharmaceuticals Corporation
05 6Novartis South Africa (Pty) Ltd
01 6CPS
02 1Capsule - Powder for Inhalation
03 9Inh Caps
04 6Inh Kaps
05 1Inhalation Powder
06 2POWDER;INHALATION
07 2Blank
01 2DISCN
02 6Originator
03 19Blank
01 1ARCAPTA NEOHALER
02 6Atectura Breezhaler
03 1Bemrist Breezhaler 150/160
04 1Bemrist Breezhaler 150/320
05 1Bemrist Breezhaler 150/80
06 2Enerzair Breezhaler Inha
07 1Enerzair Breezhaler Inha+Sens
08 2Onbrez
09 4Onbrez Breezhaler
10 1UTIBRON
11 3Ultibro Breezhaler
12 1Zimbus Breezhaler 150/50/160
13 1Zimbus Breezhaler 150/50/80
14 2Blank
01 2Australia
02 6South Africa
03 2Spain
04 15Switzerland
05 2USA
Regulatory Info :
Registration Country : Spain
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
Regulatory Info :
Registration Country : Spain
Indacaterol Maleate; Glycopyrronium Bromide
Brand Name :
Dosage Form : Inhalation Powder
Dosage Strength : 85; 43
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info :
Registration Country : Switzerland
Brand Name : Onbrez Breezhaler
Dosage Form : Inh Caps
Dosage Strength : 0.15mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Onbrez Breezhaler
Dosage Form : Inh Caps
Dosage Strength : 0.3mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Onbrez Breezhaler
Dosage Form : Inh Caps
Dosage Strength : 0.15mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Onbrez Breezhaler
Dosage Form : Inh Caps
Dosage Strength : 0.3mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
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
Regulatory Info :
Registration Country : Switzerland
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
Regulatory Info :
Registration Country : Switzerland
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
Regulatory Info :
Registration Country : Switzerland
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
Regulatory Info :
Registration Country : Switzerland
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
Regulatory Info :
Registration Country : Switzerland
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
Regulatory Info :
Registration Country : Switzerland
Brand Name : Ultibro Breezhaler
Dosage Form : Inh Caps
Dosage Strength : 110mcg/50mcg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Ultibro Breezhaler
Dosage Form : Inh Caps
Dosage Strength : 110mcg/50mcg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
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
Regulatory Info :
Registration Country : Switzerland
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
Regulatory Info :
Registration Country : Switzerland
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
Regulatory Info : Originator
Registration Country : South Africa
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Originator
Registration Country : South Africa
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Bemrist Breezhaler 150/320
Dosage Form : CPS
Dosage Strength : 150mcg
Packaging : 30X1mcg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Zimbus Breezhaler 150/50/80
Dosage Form : CPS
Dosage Strength : 150mcg
Packaging : 30X1mcg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Zimbus Breezhaler 150/50/160
Dosage Form : CPS
Dosage Strength : 150mcg
Packaging : 30X1mcg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Ultibro Breezhaler
Dosage Form : CPS
Dosage Strength : 110mcg
Packaging : 30X1mcg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Onbrez
Dosage Form :
Dosage Strength :
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Onbrez
Dosage Form :
Dosage Strength :
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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