Trelegy Ellipta
- Name:
Trelegy Ellipta
- Company:
GlaxoSmithKline (Ireland) Ltd
- Active Ingredients:
Fluticasone furoate, Umeclidinium bromide, Vilanterol trifenatate
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/01/19
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GlaxoSmithKline (Ireland) Ltd
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Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 2 January 2019 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 21 November 2018 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 21 November 2018 SmPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.1 - Addition of indication
Section 4.8 - cross reference to the effects on symptoms is added based on the results of studies
Section 5.1 - additional information related to the clinical efficacy based on the results of studies
Section 5.2 - additional information related to the pharmacokinetic properties based on the results of studies
Section 5.3 - additional information related to the pre-clinical safety data based on the results of studies
Updated on 8 June 2018 SmPC
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
- Improved presentation of SmPC
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
– Addition of ATC code to Section 5.1 of the SmPC;
– Editorial changes to:
– spelt out the name of the marketing authorisation holder in full
– add zeros in the marketing authorisation numbers
Updated on 7 June 2018 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to further information section
Updated on 9 March 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 8 March 2018 PIL
Reasons for updating
- New PIL for new product