Trelegy Ellipta *
Pharmacy Only: Prescription

Updated on 01 August 2022

File name

62e792835f26a.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Correction of spelling/typing errors
  • Removal of Black Inverted Triangle

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

Updated on 01 August 2022

File name

62e791e8166dc.pdf

Reasons for updating

  • 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
  • Removal of Black Inverted Triangle
  • Correction of spelling/typing errors

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