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01 4Novartis Pharmaceuticals Australia Pty Limited
02 36Novartis Pharmaceuticals Corporation
03 6Novartis South Africa (Pty) Ltd
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01 6CPS
02 16Capsule For Inhalation
03 6Inhalation Powder (Hard Capsule)
04 2POWDER;INHALATION
05 12Powder For Inhalation Hard Capsule
06 4Blank
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01 7Allowed
02 9Approved
03 18Authorized
04 2DISCN
05 6Originator
06 4Blank
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01 1ARCAPTA NEOHALER
02 3Atectura Breezhaler ?g
03 1Bemrist Breezhaler 150/160
04 1Bemrist Breezhaler 150/320
05 1Bemrist Breezhaler 150/80
06 1Enerzair Breezhaler ?g
07 4Hirobriz Breezhaler
08 4Onbrez
09 12Onbrez Breezhaler
10 4Oslif Breezhaler
11 1UTIBRON NEOHALER
12 6Ultibro Breezhaler
13 1Ulunar Breezhaler
14 4Xoterna Breezhaler
15 1Zimbus Breezhaler 150/50/160
16 1Zimbus Breezhaler 150/50/80
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01 4Australia
02 6South Africa
03 18Spain
04 9Sweden
05 7Switzerland
06 2USA
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 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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Allowed
Registration Country : Switzerland
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
Regulatory Info : Allowed
Registration Country : Switzerland
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
Regulatory Info : Allowed
Registration Country : Switzerland
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
Regulatory Info : Allowed
Registration Country : Switzerland
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
Regulatory Info : Allowed
Registration Country : Switzerland
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
Regulatory Info : Allowed
Registration Country : Switzerland
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
Regulatory Info : Allowed
Registration Country : Switzerland
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
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