Approvals/TGA/BIRESP SPIROMAX budesonide / formoterol (eformoterol) fumarate dihydrate 400 microgram / 12 microgram powder for inhalation dry powder inhaler

Approved

STANDARD

BIRESP SPIROMAX budesonide / formoterol (eformoterol) fumarate dihydrate 400 microgram / 12 microgram powder for inhalation dry powder inhaler

Teva Pharma Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Date: Dec 9, 2025
Approval ID: 738d048271ea7471
Company: Teva Pharma Australia Pty Ltd
Type: Standard

Approval Details

Approval Id: 738d048271ea7471
Product Name: BIRESP SPIROMAX budesonide / formoterol (eformoterol) fumarate dihydrate 400 microgram / 12 microgram powder for inhalation dry powder inhaler
Artg Id: 267384
Artg Name: BIRESP SPIROMAX budesonide / formoterol (eformoterol) 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/14533f583754a0c457d23c26ff16f146.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/ba4adf1660c8a864552ce0c3b3f8d971.pdf

Approved

Quick Info

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

738d048271ea7471

Type

Standard

Back to TGA Approvals