Approvals/TGA/DUORESP SPIROMAX budesonide / formoterol fumarate dihydrate 400 microgram / 12 microgram powder for inhalation dry powder inhaler

Approved

STANDARD

DUORESP SPIROMAX budesonide / formoterol fumarate dihydrate 400 microgram / 12 microgram powder for inhalation dry powder inhaler

Teva Pharma Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: f4d6da32142fa467
Product Name: DUORESP SPIROMAX budesonide / formoterol fumarate dihydrate 400 microgram / 12 microgram powder for inhalation dry powder inhaler
Artg Id: 267386
Artg Name: DUORESP SPIROMAX budesonide / formoterol fumarate dihydrate 400 microgram / 12 microgram powder for inhalation dry powder inhaler
Sponsor: Teva Pharma Australia Pty Ltd
Company Detail Path: /organization/teva-pharma-australia-pty-ltd
Artg Date: 2016-12-19
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/56b53a038f1a9d346ee735f2915dd05d.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/ce700bc80d070485b1a3caeca333664f.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

f4d6da32142fa467

Type

Standard