Shingrix powder and suspension for suspension for injection, Herpes zoster vaccine (recombinant, adjuvanted)

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Pharmacy Only: Prescription

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