BREO ELLIPTA DIN 02444186
Health Canada record
| Active ingredient(s) | FLUTICASONE FUROATE 200 MCG; VILANTEROL (VILANTEROL TRIFENATATE) 25 MCG |
|---|---|
| Dosage form | Powder |
| Route | Inhalation |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | R03AK10 VILANTEROL AND FLUTICASONE FUROATE |
| Original market date | 02-Oct-2015 |
| Current status date | 02-Oct-2015 |
| Source | Health Canada DPD |
Establishment licence of the holder
GlaxoSmithKline Inc. — licence 100630, currently licensed, last inspection rating C (2025-09-15).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing FLUTICASONE FUROATE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02446561 | ARNUITY ELLIPTA | GLAXOSMITHKLINE INC | Powder | FLUTICASONE FUROATE 100 MCG | Marketed |
| 02446588 | ARNUITY ELLIPTA | GLAXOSMITHKLINE INC | Powder | FLUTICASONE FUROATE 200 MCG | Marketed |
| 02298589 | AVAMYS | GLAXOSMITHKLINE INC | Spray (Metered-Dose) | FLUTICASONE FUROATE 27.5 MCG | Marketed |
| 02408872 | BREO ELLIPTA | GLAXOSMITHKLINE INC | Powder | FLUTICASONE FUROATE 100 MCG; VILANTEROL (VILANTEROL TRIFENATATE) 25 MCG | Marketed |
| 02474522 | TRELEGY ELLIPTA | GLAXOSMITHKLINE INC | Powder | FLUTICASONE FUROATE 100 MCG; UMECLIDINIUM (UMECLIDINIUM BROMIDE) 62.5 MCG; VILANTEROL (VILANTEROL TRIFENATATE) 25 MCG | Marketed |
| 02515776 | TRELEGY ELLIPTA | GLAXOSMITHKLINE INC | Powder | FLUTICASONE FUROATE 200 MCG; UMECLIDINIUM (UMECLIDINIUM BROMIDE) 62.5 MCG; VILANTEROL (VILANTEROL TRIFENATATE) 25 MCG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 17164 | 2015-08-05 | Supplement to a New Drug Submission (SNDS) | APPROVAL OF BREO ELLIPTA 100/25 MCG AND 200/25 MCG FOR THE TREATMENT OF ASTHMA |
International API supply for FLUTICASONE FUROATE
5 valid EDQM Certificates of Suitability from 5 holders. 15 active FDA Drug Master Files.
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