Approvals/TGA/ULTIBRO BREEZHALER 110/50 indacaterol (as maleate)/ glycopyrronium (as bromide) 110 microgram / 50 microgram powder for inhalation in hard capsule

Approved

STANDARD

ULTIBRO BREEZHALER 110/50 indacaterol (as maleate)/ glycopyrronium (as bromide) 110 microgram / 50 microgram powder for inhalation in hard capsule

Novartis Pharmaceuticals Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Date: May 29, 2025
Approval ID: e5d9f3164b80c9a7
Company: Novartis Pharmaceuticals Australia Pty Ltd
Type: Standard

Approval Details

Approval Id: e5d9f3164b80c9a7
Product Name: ULTIBRO BREEZHALER 110/50 indacaterol (as maleate)/ glycopyrronium (as bromide) 110 microgram / 50 microgram powder for inhalation in hard capsule
Artg Id: 206449
Artg Name: ULTIBRO BREEZHALER 110/50 indacaterol (as maleate)/ glycopyrronium (as bromide) 110 microgram / 50 microgram powder for inhalation in hard capsule
Sponsor: Novartis Pharmaceuticals Australia Pty Ltd
Company Detail Path: /organization/novartis-pharmaceuticals-australia-pty-ltd
Artg Date: 2014-03-21
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/1d2da7ec8d3207f60071420c912ad683.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/1797b55a8d40d40287c9ebdf9be364c3.pdf

Active Ingredients

Approved

Quick Info

Agency

TGA

Country

🇦🇺

Approval Date

May 29, 2025

Approval ID

e5d9f3164b80c9a7

Type

Standard

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