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01 27Novartis Europharm Limited
02 7Novartis Pharma Schweiz Ag
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01 9Glycopyrronium Bromide; Indacaterol Maleate
02 2Indacaterol
03 16Indacaterol Maleate
04 1Indacaterol; Glycopyrronium
05 1Indacaterol; Glycopyrronium; Mometasone Furose
06 3Indacaterol; Mometasone Furoate
07 2Indigo
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01 16Capsule For Inhalation
02 6Inhalation Powder (Hard Capsule)
03 12Powder For Inhalation Hard Capsule
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01 18Spain
02 9Sweden
03 7Switzerland
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01 3Atectura Breezhaler ?g
02 1Enerzair Breezhaler ?g
03 4Hirobriz Breezhaler
04 12Onbrez Breezhaler
05 4Oslif Breezhaler
06 5Ultibro Breezhaler
07 1Ulunar Breezhaler
08 4Xoterna Breezhaler
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