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01 20Novartis Pharmaceuticals Corporation

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PharmaCompass

01

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

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

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

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

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

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

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

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

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

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

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

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

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

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

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

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

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

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

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

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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11

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

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

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12

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

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

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13

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

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

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14

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

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

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15

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

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

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16

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

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

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17

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

INDACATEROL (INDACATEROL ACETATE)

Brand Name : ATECTURA BREEZHALER

Dosage Form : CAPSULE

Dosage Strength : 150MCG

Packaging :

Approval Date :

Application Number : 2498685

Regulatory Info : Prescription

Registration Country : Canada

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18

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

INDACATEROL (INDACATEROL ACETATE)

Brand Name : ATECTURA BREEZHALER

Dosage Form : CAPSULE

Dosage Strength : 150MCG

Packaging :

Approval Date :

Application Number : 2498693

Regulatory Info : Prescription

Registration Country : Canada

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19

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

INDACATEROL (INDACATEROL ACETATE)

Brand Name : ATECTURA BREEZHALER

Dosage Form : CAPSULE

Dosage Strength : 150MCG

Packaging :

Approval Date :

Application Number : 2498707

Regulatory Info : Prescription

Registration Country : Canada

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20

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

INDACATEROL (INDACATEROL ACETATE)

Brand Name : ENERZAIR BREEZHALER

Dosage Form : CAPSULE

Dosage Strength : 150MCG

Packaging :

Approval Date :

Application Number : 2501244

Regulatory Info : Prescription

Registration Country : Canada

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