Medicine
Breo Ellipta 200 mcg/25 mcg inhalation powder
Breo Ellipta 200 mcg/25 mcg inhalation powder is a prescription medicine containing Fluticasone furoate and Vilanterol for inhalation use, marketed by GlaxoSmithKline, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at room temperature between 68°F and 77°F (20°C and 25°C), excursions…
Key facts
- Active ingredient (INN)
- Fluticasone furoate and Vilanterol
- Brand
- Breo Ellipta
- Strength
- 200 mcg/25 mcg
- Dosage form
- Inhalation powder
- Route
- Inhalation
- Packs
- 1 tray
- Marketing authorisation holder
- GlaxoSmithKline
- Manufacturer
- GlaxoSmithKline
- Origin register
- US FDA, United States
- Storage
- Store at room temperature between 68°F and 77°F (20°C and 25°C), excursions permitted from 59°F to 86°F (15°C to 30°C). Store in a dry place away from direct heat or sunlight. BREO ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R03AK10 Fluticasone furoate and Vilanterol
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 April 2015
- Identifiers
- RxCUI 1424889, 1424899, 1539891 +7DailyMed set ID 96428df1-ea05-431a-98d3-1ec2c4b63878NDC 0173-0882Application NDA204275
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 tray in 1 carton / 1 inhaler in 1 tray / 30 powder in 1 inhaler | 0173-0882-10 | GlaxoSmithKline | 30 April 2015 |
| 1 tray in 1 carton / 1 inhaler in 1 tray / 14 powder in 1 inhaler | 0173-0882-14 | GlaxoSmithKline | 30 April 2015 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Fluticasone furoate and Vilanterol 200 mcg/25 mcg inhalation powder.
Other strengths and forms of Fluticasone furoate and Vilanterol
Clinical summary
Fluticasone furoate and Vilanterol is a fixed-dose combination of a corticosteroid and a beta2-adrenergic agonist indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), among other approved uses. MedsAcross supplies Fluticasone furoate and Vilanterol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Fluticasone furoate and VilanterolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Fluticasone Furoate and Vilanterol prescribing information (Prasco Laboratories) · U.S. National Library of Medicine, DailyMed
- Relvar Ellipta: European public assessment report (EPAR) · European Medicines Agency
- Revinty Ellipta: European public assessment report (EPAR) · European Medicines Agency
Need Breo Ellipta 200 mcg/25 mcg inhalation powder for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.