Arexvy powder and suspension for suspension for injection
*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 16 April 2024
File name
ieukni-spc-combined-arexvy-issue3draft1Master.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Type II Flu co-administration
In addition, 2 other label changes were included in this variation:
- Removal of the statement “Close observation for at least 15min…” in section 4.4
Updated on 07 February 2024
File name
ieukni-spc-combined-arexvy-issue2draft1-Master.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
Update to section 6.3 - shelf life extension from 2 years to 3 years.
Updated on 14 September 2023
File name
ieukni-spc-combined-arexvy-issue1draft1-Master.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 September 2023
File name
ieukni-spc-combined-arexvy-issue1draft1-Master.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 September 2023
File name
ieukni-pil-combined-arexvy-issue1draft1-Master.pdf
Reasons for updating
- New PIL for new product