Arexvy powder and suspension for suspension for injection
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
No Recent UpdateLegal 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 04 September 2024
File name
ie-spc-arexvy-issue5draft1-Master.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.6 - Pregnancy and lactation
- 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 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 of AREXVY vaccine SPC with an extension of the indication to adults 50-59 Years Of Age (YOA) who are at increased risk for RSV disease.
The following sections of the SPC have been updated:
Section 4.1 to include extension of the indication:
· adults 50 through 59 years of age who are at increased risk for RSV disease.
Sections 4.6, 4.8 (including frequency change of injection site erythema AE from common to very common), section 5.1 and 5.3 .
Updated on 04 September 2024
File name
ie-pil-arexvy-issue3draft1-Master.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 04 July 2024
File name
ie-pil-arexvy-issue2draft1-clean-no headers.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 03 July 2024
File name
ie-spc-arexvy-issue4draft1-clean-no headers.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
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