Approvals/TGA/ATECTURA BREEZHALER 125/127.5 indacaterol (as acetate)/mometasone furoate 125/127.5 mcg powder for inhalation in hard capsule with inhaler

Approved

STANDARD

ATECTURA BREEZHALER 125/127.5 indacaterol (as acetate)/mometasone furoate 125/127.5 mcg powder for inhalation in hard capsule with inhaler

Novartis Pharmaceuticals Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Date: Dec 9, 2025
Approval ID: 83709511e03a6e00
Company: Novartis Pharmaceuticals Australia Pty Ltd
Type: Standard

Approval Details

Approval Id: 83709511e03a6e00
Product Name: ATECTURA BREEZHALER 125/127.5 indacaterol (as acetate)/mometasone furoate 125/127.5 mcg powder for inhalation in hard capsule with inhaler
Artg Id: 319075
Artg Name: ATECTURA BREEZHALER 125/127.5 indacaterol (as acetate)/mometasone furoate 125/127.5 mcg powder for inhalation in hard capsule with inhaler
Sponsor: Novartis Pharmaceuticals Australia Pty Ltd
Company Detail Path: /organization/novartis-pharmaceuticals-australia-pty-ltd
Artg Date: 2020-07-21
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2021-CMI-01029-1
Product Information: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2020-PI-01980-1

Approved

Quick Info

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

83709511e03a6e00

Type

Standard

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