Approvals/TGA/BUFOMIX EASYHALER 200/6 budesonide/formoterol (eformoterol) fumarate dihydrate 160 ug/4.5 ug per inhalation powder for inhalation dry powder inhaler

Approved

STANDARD

BUFOMIX EASYHALER 200/6 budesonide/formoterol (eformoterol) fumarate dihydrate 160 ug/4.5 ug per inhalation powder for inhalation dry powder inhaler

Orion Pharma (AUS) Pty Limited🇦🇺 Therapeutic Goods Administration

Approval Date: Dec 9, 2025
Approval ID: 7600aacd31a00e8b
Company: Orion Pharma (AUS) Pty Limited
Type: Standard

Approval Details

Approval Id: 7600aacd31a00e8b
Product Name: BUFOMIX EASYHALER 200/6 budesonide/formoterol (eformoterol) fumarate dihydrate 160 ug/4.5 ug per inhalation powder for inhalation dry powder inhaler
Artg Id: 338159
Artg Name: BUFOMIX EASYHALER 200/6 budesonide/formoterol (eformoterol) fumarate dihydrate 160 ug/4.5 ug per inhalation powder for inhalation dry powder inhaler
Sponsor: Orion Pharma (AUS) Pty Limited
Company Detail Path: /organization/orion-pharma-aus-pty-limited
Artg Date: 2022-10-28
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/27d6a034e0b6a785b94afbf078b63bd7.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/131299f5eba3d709558a1e54868e788c.pdf

Approved

Quick Info

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

7600aacd31a00e8b

Type

Standard

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