Xevudy 500 mg concentrate for solution for infusion
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 24 April 2024
File name
ie-spc-xevudy-issue14draft1-clean.pdf
Reasons for updating
- 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 not be renewed (A)
Updated on 11 March 2024
File name
ie-spc-xevudy-issue13draft1-clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 February 2024
File name
ie-spc-xevudy-issue12draft1-clean.pdf
Reasons for updating
- 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 not be renewed (A)
Updated on 15 December 2023
File name
ni&ie-pl-xevudy-issue4draft1-clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 15 December 2023
File name
ie-spc-xevudy-issue11draft1-clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 October 2023
File name
ie-spc-xevudy-issue10draft1-clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Type IB variation to extend the drug product shelf life to 30 months.
Updated on 07 September 2023
File name
ie-spc-xevudy-issue9draft1-clean-no headers.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 July 2023
File name
ie-spc-xevudy-issue8draft1-compendia.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated Section 4.1 - Therapeutic Indications, Section 4.2 - Posology and Method of administration, Section 4.4 - Special warnings and precautions for use, Section 5.1 - Pharmacodynamic properties and Date of revision of the text.
Updated on 13 January 2023
File name
ie-spc-xevudy-issue7draft1-clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 January 2023
File name
ie-spc-xevudy-issue6draft1.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 December 2022
File name
ie-spc-xevudy-issue5draft1-clean no headers.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
reloading SPC onto medicines.ie due to typo error
Updated on 01 December 2022
File name
ie-spc-xevudy-issue4draft2-clean no headers.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Inclusion of variants BA2.75 and BA.3
Updated on 30 November 2022
File name
ie-spc-xevudy-issue4draft1-clean no headers.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
shelf life updated to 2 years
Updated on 01 August 2022
File name
ie-spc-xevudy-issue3draft1-clean-no headers.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to pseudovirus type BA.2.12.1, BA.4 and BA.5
Updated on 10 June 2022
File name
ni&ie-pl-xevudy-issue3draft1-no header.pdf
Reasons for updating
- Change to further information section
Free text change information supplied by the pharmaceutical company
removal of reference to QR code
Updated on 06 May 2022
File name
ni&ie-pl-xevudy-issue2draft1-clean no headers.pdf
Reasons for updating
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
minor update to dilution process
Updated on 06 May 2022
File name
ie-spc-xevudy-issue2draft1-clean medicines.ie.pdf
Reasons for updating
- 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 5.3 - Preclinical safety data
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
inclusion of BA2 omicron clinical data and minor udpate to dilution process.
Updated on 11 April 2022
File name
ni&ie-pl-xevudy-issue1draft3-medicines.ie.pdf
Reasons for updating
- New PIL for new product
Updated on 01 April 2022
File name
ie-spc-xevudy-issue1draft2-medicines.ie.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 April 2022
File name
ie-spc-xevudy-issue1draft2-clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)