Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed

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Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed

Name:
Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed
Company:
GlaxoSmithKline (Ireland) Ltd
Active Ingredients:
Fluticasone furoate, 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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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 - marketing authorisation holder
Change to section 6 - date of revision

Updated on 2 January 2019 SmPC

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 PIL

Reasons for updating

Change to section 6 - date of revision
Change to other sources of information section

Updated on 24 September 2018 PIL

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 SmPC

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 7 August 2018 PIL

Reasons for updating

Change to section 6 - date of revision
Improved presentation of PIL

Updated on 7 August 2018 SmPC

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 SmPC

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 PIL

Reasons for updating

Removal of Black Inverted Triangle

Updated on 30 April 2018 SmPC

Reasons for updating

New SmPC for new product

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

Updated on 13 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 13 March 2018 SmPC

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

SPC updated in sections 4.1 and 5.1 to include the indication extension for use in asthma.

Updated on 21 September 2017 PIL

Reasons for updating

New PIL for new product

Updated on 21 September 2017 SmPC

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 PIL

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 SmPC

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

SPC Section 4.5. Interaction with other medicinal products and other forms of interaction
Update to align to PRAC recommendation on drug interaction with corticosteroids

Updated on 31 May 2017 PIL

Reasons for updating

Change to section 2 - interactions with other medicines, food or drink
Change to section 6 - date of revision

Updated on 4 May 2017 SmPC

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 3 May 2017 PIL

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 SmPC

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

Section 4.4 Special warnings and precautions for use
Pneumonia in patients with COPD
Rewording text in line with Article 31 referral

Updated on 8 July 2016 PIL

Reasons for updating

Change to side-effects
Change to date of revision

Updated on 22 January 2016 PIL

Reasons for updating

Change of manufacturer
Change to date of revision

Updated on 23 December 2015 SmPC

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 PIL

Reasons for updating

Change to side-effects
Change to date of revision
Change to MA holder contact details

Updated on 30 September 2015 SmPC

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

Update section 4.8 of the SPC in order to add anxiety and tremor as new adverse reactions with the frequency rare

Updated on 29 September 2015 PIL

Reasons for updating

Change to side-effects
Change to further information section
Change to date of revision

Updated on 6 July 2015 SmPC

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 1 July 2015 PIL

Reasons for updating

Change to warnings or special precautions for use
Change to side-effects
Change to date of revision

Updated on 8 January 2015 SmPC

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 6 January 2015 PIL

Reasons for updating

Change to side-effects
Change to date of revision

Updated on 5 January 2015 PIL

Reasons for updating

Change to side-effects

Updated on 10 June 2014 PIL

Reasons for updating

Change to warnings or special precautions for use
Change to date of revision

Updated on 3 February 2014 SmPC

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

Changes to:

Section 4.8 - Undesirable effects

Updated on 29 January 2014 PIL

Reasons for updating

Change to side-effects

Updated on 9 December 2013 SmPC

Reasons for updating

New SPC for new product

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