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01 16Novartis Europharm Limited

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PharmaCompass

01

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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

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02

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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

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03

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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

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04

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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

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05

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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

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06

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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

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07

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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

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08

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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

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09

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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

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10

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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

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