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01 16Novartis Pharmaceuticals Corporation
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01 8Capsule For Inhalation
02 8Powder For Inhalation Hard Capsule
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01 8Approved
02 8Authorized
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01 6Atectura Breezhaler
02 6Bemrist Breezhaler
03 2Enerzair Breezhaler
04 2Zimbus Breezhaler
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01 8Spain
02 8Sweden
Regulatory Info : Approved
Registration Country : Sweden
Glycopyrronium Bromide; Indacaterol Acetate; Mometasone Furoate
Brand Name : Enerzair Breezhaler
Dosage Form : Capsule For Inhalation
Dosage Strength : 114mcg;46mcg;136mcg
Packaging :
Approval Date : 03/07/2020
Application Number : 20190506000094
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Glycopyrronium Bromide; Indacaterol Acetate; Mometasone Furoate
Brand Name : Zimbus Breezhaler
Dosage Form : Capsule For Inhalation
Dosage Strength : 114mcg;46mcg;136mcg
Packaging :
Approval Date : 03/07/2020
Application Number : 20191111000073
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Indacaterol Acetate; Mometasone Furoate
Brand Name : Atectura Breezhaler
Dosage Form : Capsule For Inhalation
Dosage Strength : 125mcg;127.5mcg
Packaging :
Approval Date : 30/05/2020
Application Number : 20190506000063
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Indacaterol Acetate; Mometasone Furoate
Brand Name : Bemrist Breezhaler
Dosage Form : Capsule For Inhalation
Dosage Strength : 125mcg;127.5mcg
Packaging :
Approval Date : 30/05/2020
Application Number : 20191111000035
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Indacaterol Acetate; Mometasone Furoate
Brand Name : Atectura Breezhaler
Dosage Form : Capsule For Inhalation
Dosage Strength : 125mcg;260mcg
Packaging :
Approval Date : 30/05/2020
Application Number : 20190506000070
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Indacaterol Acetate; Mometasone Furoate
Brand Name : Bemrist Breezhaler
Dosage Form : Capsule For Inhalation
Dosage Strength : 125mcg;260mcg
Packaging :
Approval Date : 30/05/2020
Application Number : 20191111000042
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Indacaterol Acetate; Mometasone Furoate
Brand Name : Atectura Breezhaler
Dosage Form : Capsule For Inhalation
Dosage Strength : 125mcg;62.5mcg
Packaging :
Approval Date : 30/05/2020
Application Number : 20190506000056
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Indacaterol Acetate; Mometasone Furoate
Brand Name : Bemrist Breezhaler
Dosage Form : Capsule For Inhalation
Dosage Strength : 125mcg;62.5mcg
Packaging :
Approval Date : 30/05/2020
Application Number : 20191111000028
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Authorized
Registration Country : Spain
Glycopyrronium Bromide; Mometasona Furoate; Indacaterol Acetate
Brand Name : Enerzair Breezhaler
Dosage Form : Powder For Inhalation Hard Capsule
Dosage Strength : 114MGC; 46MCG; 136 MCG
Packaging :
Approval Date : 2020-08-10
Application Number : 1201438002
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Glycopyrronium Bromide; Mometasona Furoate; Indacaterol Acetate
Brand Name : Zimbus Breezhaler
Dosage Form : Powder For Inhalation Hard Capsule
Dosage Strength : 114MGC; 46MCG; 136 MCG
Packaging :
Approval Date : 2020-12-16
Application Number : 1201440002
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Mometasone Furoate; Indacaterol Acetate
Brand Name : Atectura Breezhaler
Dosage Form : Powder For Inhalation Hard Capsule
Dosage Strength : 125MCG; 260 MCG
Packaging :
Approval Date : 2020-08-10
Application Number : 1201439010
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Mometasone Furoate; Indacaterol Acetate
Brand Name : Bemrist Breezhaler
Dosage Form : Powder For Inhalation Hard Capsule
Dosage Strength : 125MCG; 62.5 MCG
Packaging :
Approval Date : 2020-12-16
Application Number : 1201441002
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Mometasone Furoate; Indacaterol Acetate
Brand Name : Atectura Breezhaler
Dosage Form : Powder For Inhalation Hard Capsule
Dosage Strength : 125MCG; 62.5 MCG
Packaging :
Approval Date : 2020-08-10
Application Number : 1201439002
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Mometasone Furoate; Indacaterol Acetate
Brand Name : Bemrist Breezhaler
Dosage Form : Powder For Inhalation Hard Capsule
Dosage Strength : 125MCG; 127.5 MCG
Packaging :
Approval Date : 2020-12-16
Application Number : 1201441006
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Mometasone Furoate; Indacaterol Acetate
Brand Name : Atectura Breezhaler
Dosage Form : Powder For Inhalation Hard Capsule
Dosage Strength : 125MCG; 127.5 MCG
Packaging :
Approval Date : 2020-08-10
Application Number : 1201439006
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Mometasone Furoate; Indacaterol Acetate
Brand Name : Bemrist Breezhaler
Dosage Form : Powder For Inhalation Hard Capsule
Dosage Strength : 125MCG; 260 MCG
Packaging :
Approval Date : 2020-12-16
Application Number : 1201441010
Regulatory Info : Authorized
Registration Country : Spain