Product Dossier
Bufomix Easyhaler
Product Dossier for Bufomix Easyhaler (budesonide, formoterol fumarate dihydrate, Orion Pharma (AUS)). ARTG record, PBS listing, PBAC outcomes — compiled…
- Sponsor: Orion Pharma (AUS)
- Active ingredient: budesonide, formoterol fumarate dihydrate
- Therapeutic area: Respiratory
- Related brand: PULMICORT
- Related brand: BUDENOFALK
- Related brand: JORVEZA
- Same area: NUCALA
- Same area: VENTOLIN
What it is
BUFOMIX EASYHALER is a powder for inhalation dry powder inhaler containing budesonide and formoterol (eformoterol) fumarate dihydrate. Two strengths are registered: 200/6 micrograms per inhalation (160 micrograms budesonide / 4.5 micrograms formoterol) and 400/12 micrograms per inhalation (320 micrograms budesonide / 9 micrograms formoterol).
Approved indications
BUFOMIX EASYHALER is indicated for asthma and chronic obstructive pulmonary disease (COPD).
PBS listing
BUFOMIX EASYHALER was recommended for PBS listing in November 2023 as bioequivalent to Symbicort Turbuhaler on a cost-minimisation basis to the lowest cost PBS-listed budesonide with formoterol powder for inhalation.
Regulatory history
BUFOMIX EASYHALER was first registered on the ARTG on 28 October 2022. The product received a PBAC recommendation for listing in November 2023.