Approvals/TGA/ENERZAIR BREEZHALER 114/46/68 indacaterol/glycopyrronium/mometasone furoate 114/46/68 microgram powder for inhalation in capsule with inhaler

Approved

STANDARD

ENERZAIR BREEZHALER 114/46/68 indacaterol/glycopyrronium/mometasone furoate 114/46/68 microgram powder for inhalation in capsule with inhaler

Novartis Pharmaceuticals Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Date: Dec 9, 2025
Approval ID: 63c00163ac1fc021
Company: Novartis Pharmaceuticals Australia Pty Ltd
Type: Standard

Approval Details

Approval Id: 63c00163ac1fc021
Product Name: ENERZAIR BREEZHALER 114/46/68 indacaterol/glycopyrronium/mometasone furoate 114/46/68 microgram powder for inhalation in capsule with inhaler
Artg Id: 319002
Artg Name: ENERZAIR BREEZHALER 114/46/68 indacaterol/glycopyrronium/mometasone furoate 114/46/68 microgram powder for inhalation in capsule with inhaler
Sponsor: Novartis Pharmaceuticals Australia Pty Ltd
Company Detail Path: /organization/novartis-pharmaceuticals-australia-pty-ltd
Artg Date: 2020-10-20
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/674e50c45ac9676f9e89e8788c6eaeef.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/726fd06ea7df602929fb47bf744cbf35.pdf

Approved

Quick Info

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

63c00163ac1fc021

Type

Standard

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