Shingrix powder and suspension for suspension for injection, Herpes zoster vaccine (recombinant, adjuvanted)
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 27 August 2024
File name
ie-spc-shingrix-issue11draft1_medicines.ie.pdf
Reasons for updating
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to Section 4.8 - removal of Northern Ireland (UK) Reporting Details
Updated on 27 August 2024
File name
ie-spc-shingrix-issue11draft1_medicines.ie.pdf
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 not be renewed (A)
Updated on 27 August 2024
File name
ie-pl-shingrix-issue4draft1_medicines.ie.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 01 November 2023
File name
ieukni-spc-combined-shingrix-issue10draft1-clean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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 section 4.5 - Co-administration with Covid-19 mRNA vaccine
Update to section 9 - Addition of renewal date
Updated on 01 November 2023
File name
ieukni-pl-combined-shingrix-issue3draft1-clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 04 January 2023
File name
ieukni-spc-combined-shingrix-issue9draft1.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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 04 January 2023
File name
ieukni-pl-combined-shingrix-issue2draft1.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - driving and using machines
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Removal of Black Inverted Triangle
- Change to date of revision
Updated on 27 October 2022
File name
ieukni-spc-combined-shingrix-issue8draft2 - for medicines ie.pdf
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 not be renewed (A)
Updated on 30 January 2022
File name
ieukni-spc-combined-shingrix-issue7draft1-medicines.ie.pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
formatting changes to the header of the document.
Updated on 26 January 2022
File name
ieukni-spc-combined-shingrix-issue7draft1-clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 January 2022
File name
ieukni-pl-shingrixissue1draft1-medicines.ie.pdf
Reasons for updating
- New PIL for new product