TGA / PMDA / NMPA · Asia-Pacific
fluticasone furoate + vilanterol — TGA / PMDA / NMPA regulatory status
fluticasone furoate + vilanterol (BREO ELLIPTA 100/25) regulatory status in the Asia-Pacific is tracked from public TGA / PMDA / NMPA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: TGA approved.
Status snapshot
- Status
- TGA approved
- Brand
- BREO ELLIPTA 100/25
- Originator
- GlaxoSmithKline
- Structured fields
- 5
Sponsor / originator context: GlaxoSmithKline. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Regional decision snapshot — TGA: approved.
Linked evidence on this spoke: 1 published clinical program and 0 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| TGA | Australia | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| fluticasone furoate/vilanterol | Phase 3 | GSK Glaxo Smith | NCT01376245 |
Related hubs
FAQ
What is the TGA / PMDA / NMPA approval status of fluticasone furoate + vilanterol?
fluticasone furoate + vilanterol currently shows TGA approved in our Asia-Pacific regulatory index. Confirm on the official TGA / PMDA / NMPA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get fluticasone furoate + vilanterol regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to fluticasone furoate + vilanterol?
This spoke lists 1 published program associated with fluticasone furoate + vilanterol in our pipeline index.