Trelegy Ellipta *
Pharmacy Only: Prescription

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 26 November 2021

File name

ieukni-pl-combined-trelegyellipta-issue8draft1-compendia_1637949429.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 26 November 2021

File name

ieukni-spc-combined-trelegyellipta-issue6draft1-compendia_1637949130.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 18 February 2021

File name

ie-pil-trelegyellipta-issue7draft1-clean - medie_1613659807.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 22 September 2020

File name

ie-spc-trelegyellipta-issue5draft1-medie_1600788659.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 22 September 2020

File name

ie-pil-trelegyellipta-issue6draft1-medie_1600788569.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 19 December 2019

File name

ie-spc-trelegyellipta-issue4draft1-clean-medicines.ie_1576765233.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 19 December 2019

File name

ie-pil-trelegyellipta-issue5draft1-clean-medicines.ie_1576765178.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 02 January 2019

File name

ie-pil-trelegy-issue4draft1-MED.IE_1546432988.pdf

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

File name

ukie-pil-trelegy-issue3draft1 for Meds compendia_1542793175.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 21 November 2018

File name

ukie-spc-trelegy-issue3draft1 for Meds.ie_1542793125.pdf

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 08 June 2018

File name

ie-spc-trelegy for medicine.ie.docx

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

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 07 June 2018

File name

ie-pl-trelegy for medsie.pdf

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 09 March 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 08 March 2018

File name

PIL_17428_566.pdf

Reasons for updating

  • New PIL for new product