Overview
No overview information available.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2014/07/09 | Phase 3 | Completed | |||
2012/10/08 | Phase 3 | Completed | |||
2012/07/31 | Phase 2 | Withdrawn | |||
2012/01/30 | Phase 1 | Completed | |||
2011/07/04 | Phase 3 | Completed | |||
2011/06/13 | Phase 2 | Completed | |||
2011/03/16 | Phase 3 | Completed | |||
2010/05/24 | Phase 1 | Completed | |||
2009/09/14 | Phase 1 | Completed | |||
2008/08/12 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| GlaxoSmithKline LLC | 0173-0887 | RESPIRATORY (INHALATION) | 62.5 ug in 1 1 | 9/9/2020 | |
| GlaxoSmithKline LLC | 0173-0893 | RESPIRATORY (INHALATION) | 62.5 ug in 1 1 | 9/9/2020 | |
| GlaxoSmithKline LLC | 0173-0873 | ORAL | 62.5 ug in 1 1 | 8/17/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 5/8/2014 | ||
Authorised | 11/15/2017 | ||
Authorised | 5/8/2014 | ||
Authorised | 11/15/2017 | ||
Authorised | 4/28/2014 | ||
Authorised | 3/20/2017 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| TRELEGY ELLIPTA 100/62.5/25 fluticasone furoate 100 ug / umeclidinium (as bromide) 62.5 ug / vilanterol (as trifenatate) 25 ug powder for inhalation | 284636 | Medicine | A | 1/16/2018 | |
| INCRUSE ELLIPTA umeclidinium (as bromide) 62.5 microgram powder for inhalation | 211601 | Medicine | A | 7/8/2014 | |
| ANORO ELLIPTA 62.5/25 umeclidinium (as bromide)/vilanterol (as trifenatate) 62.5 microgram/25 microgram powder for inhalation | 207529 | Medicine | A | 7/4/2014 | |
| TRELEGY ELLIPTA 200/62.5/25 fluticasone furoate 200 ug / umeclidinium (as bromide) 62.5 ug / vilanterol (as trifenatate) 25 ug powder for inhalation | 335858 | Medicine | A | 5/10/2021 |
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