Breo Ellipta

Product manufactured by Remedyrepack Inc.

Application Nr Approved Date Route Status External Links
NDA204275 None Respiratory (Inhalation) None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Breo Ellipta Is A Combination Of Fluticasone Furoate, An Inhaled Corticosteroid (Ics), And Vilanterol, A Long-Acting Beta 2 -Adrenergic Agonist (Laba), Indicated For: Long-Term, Once-Daily, Maintenance Treatment Of Airflow Obstruction And Reducing Exacerbations In Patients With Chronic Obstructive Pulmonary Disease (Copd). ( 1.1 ) Once-Daily Treatment Of Asthma In Patients Aged 18 Years And Older. ( 1.2 ) Important Limitation Of Use: Not Indicated For Relief Of Acute Bronchospasm. ( 1.1 , 1.2 , 5.2 ) 1.1 Maintenance Treatment Of Chronic Obstructive Pulmonary Disease Breo Ellipta 100/25 Is Indicated For The Long-Term, Once-Daily, Maintenance Treatment Of Airflow Obstruction In Patients With Chronic Obstructive Pulmonary Disease (Copd), Including Chronic Bronchitis And/or Emphysema. Breo Ellipta 100/25 Is Also Indicated To Reduce Exacerbations Of Copd In Patients With A History Of Exacerbations. Breo Ellipta 100/25 Once Daily Is The Only Strength Indicated For The Treatment Of Copd. Important Limitation Of Use Breo Ellipta Is Not Indicated For The Relief Of Acute Bronchospasm. 1.2 Treatment Of Asthma Breo Ellipta Is Indicated For The Once-Daily Treatment Of Asthma In Patients Aged 18 Years And Older. Breo Ellipta Should Be Used For Patients Not Adequately Controlled On A Long-Term Asthma Control Medication Such As An Inhaled Corticosteroid (Ics) Or Whose Disease Warrants Initiation Of Treatment With Both An Ics And Long-Acting Beta 2 -Adrenergic Agonist (Laba). Important Limitation Of Use Breo Ellipta Is Not Indicated For The Relief Of Acute Bronchospasm.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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