Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 19 September 2023
File name
ieukni-pl-combined-relvar-issue20-draft1-emc.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 24 July 2023
File name
ieukni-spc-combined-relvar-184-issue19-draft1.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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 July 2023
File name
ieukni-pl-combined-relvar-issue20-draft1.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 5 - how to store or dispose
Updated on 09 November 2021
File name
ieukni-pl-combined-relvar-issue18-draft1-compendia.pdf
Reasons for updating
- 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 09 November 2021
File name
ieukni-spc-combined-relvar-184-issue17-draft1-compendia.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 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)
Updated on 18 February 2021
File name
ie-pl-relvar-issue17draft1-medie.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 02 December 2020
File name
ie-spc-relvar-184-issue16-draft1.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 02 December 2020
File name
ie-pl-relvar-issue16draft1.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- 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 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 02 January 2019
File name
ie-pl-relvar-issue15draft1-MED.IE.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 02 January 2019
File name
ie-spc-relvar-184-issue15-draft1-MED.IE.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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)
Free text change information supplied by the pharmaceutical company
Section 4.8: Splitting of pack to include just specific IE reporting details due to Brexit preparations
Section 7: Change of MAH address
Updated on 18 December 2018
File name
ukie-pl-relvar-issue14 - medicines compendium.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 24 September 2018
File name
ukie-pl-relvar-issue13draft2 for medicines compendia.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 24 September 2018
File name
ukie-spc-relvar-184-issue14-draft1 for medicines.ie.pdf
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
SPC Section 4.8 - updated to include the addition of 'hyperglycaemia' as an adverse reaction
Updated on 07 August 2018
File name
ie-pl-relvar.pdf
Reasons for updating
- Change to section 6 - date of revision
- Improved presentation of PIL
Updated on 07 August 2018
File name
ie-spc-relvar184.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 27 June 2018
File name
ukie-spc-relvar-184-22-medicines IE.docx
Reasons for updating
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Removal of Black Triangle Statement in both the SPC and PIL
Updated on 27 June 2018
File name
ukie-pl-relvar-92&184-22-medicines compendium.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Updated on 30 April 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 13 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 13 March 2018
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 5.1 - Pharmacodynamic properties
- 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
Updated on 21 September 2017
File name
PIL_15900_855.pdf
Reasons for updating
- New PIL for new product
Updated on 21 September 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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)
Free text change information supplied by the pharmaceutical company
Sections 4.4 and 4.8 has been updated in accordance with the wording proposed in the CMDh/PRAC recommendation on signals regarding ‘Blurred Vision’ and ‘Central Serous Chorioretinopathy’ as a class risk effect of corticosteroids.
Updated UK reporting details in S4.8 of SmPC to align with Appendix V requirements published by EMA.
Updated on 21 September 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 31 May 2017
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
Update to align to PRAC recommendation on drug interaction with corticosteroids
Updated on 31 May 2017
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 04 May 2017
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 5.1 - Pharmacodynamic properties
- 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 4.2 - Additional information regarding desiccant sachet
The SUMMIT submission:
-Addition of safety data to Section 4.4 and Section 4.8
-Addition of study design, mortality and CV composite endpoint data to Section 5.1.
-In addition, ‘bronchospasm’ was added to Section 4.8 List of Adverse Reactions, and there is a minor correction to the pharmacodynamics section of Section 5.1.
Updated on 03 May 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 16 November 2016
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Pneumonia in patients with COPD
Rewording text in line with Article 31 referral
Updated on 08 July 2016
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 22 January 2016
Reasons for updating
- Change of manufacturer
- Change to date of revision
Updated on 23 December 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to SPC
Update section 4.8 of the SPC in order to add muscle spasms as a new adverse reaction with the frequency Common.
Minor typographical amendment to COPD paediatric population text in section 4.2 of the SPC.
Updated on 22 December 2015
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to MA holder contact details
Updated on 30 September 2015
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
Updated on 29 September 2015
Reasons for updating
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 06 July 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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)
Free text change information supplied by the pharmaceutical company
Update section 4.4 - in order to amend warning regarding Cardiovascular effects
Update section 4.8 - addition of Palpitations and Tachycardia as new adverse reactions with the frequency rare
Updated on 01 July 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 08 January 2015
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.8 – Addition of hypersensitivity adverse event
Section 5.1 – Typo updates
Updated on 06 January 2015
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 05 January 2015
Reasons for updating
- Change to side-effects
Updated on 10 June 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 03 February 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.8 - Undesirable effects
Updated on 29 January 2014
Reasons for updating
- Change to side-effects
Updated on 09 December 2013
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 26 November 2013
Reasons for updating
- New PIL for new product