Product Dossier
Duoresp Spiromax
Product Dossier for Duoresp Spiromax (budesonide, formoterol fumarate dihydrate, Teva Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by…
- Sponsor: Teva Pharma
- Active ingredient: budesonide, formoterol fumarate dihydrate
- Therapeutic area: Respiratory
- Related brand: PULMICORT
- Related brand: BUDENOFALK
- Related brand: JORVEZA
- Same area: NUCALA
- Same area: VENTOLIN
I must inform you that the provided source documents contain a significant mismatch with your request.
The documents supplied relate to two different medicines:
1. **Document 1** describes **BUDENOFALK capsules** (budesonide 3 mg, enteric-coated) for Crohn's disease — an oral gastroenterology product.
2. **Documents 2–3** describe **DUORESP SPIROMAX** (budesonide/formoterol inhaler) for asthma and COPD — a respiratory inhalation product.
You have requested a Brand Dossier for **DUORESP SPIROMAX**, but Document 1 (which provides the detailed clinical, safety, dosing, and regulatory information needed to complete most sections of the dossier) describes a completely different medicine with a different route, indication, and formulation.
The information in Documents 2–3 about DUORESP SPIROMAX is limited to ARTG registration details and a single PBAC outcome note, which is insufficient to construct a comprehensive Brand Dossier covering indications, dosing, safety warnings, contraindications, and regulatory history.
**To proceed, I would need:** — Product Information / SmPC document for DUORESP SPIROMAX (budesonide/formoterol inhaler) — Australian Public Assessment Report (AusPAR) if available — PBS listing details if listed on the Pharmaceutical Benefits Scheme
Please supply the correct source documents for DUORESP SPIROMAX, and I will prepare the Brand Dossier as specified.