Abrysvo powder and solvent for solution for injection
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
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 02 April 2025
File name
Adv SmPC bAB 8_0 IE-clean.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 4.8 - Undesirable effects
- 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
The SPC has been updated as follows:
Sections 4.1, 4.2, 4.4, 4.8, and 5.1 have been updated for the indication extension
Updated on 02 April 2025
File name
Adv PIL IE MT bAB 5_0-clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to information for healthcare professionals
- Change to MA holder contact details
Updated on 28 March 2025
File name
Adv PIL IE MT bAB 4_1-clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 27 March 2025
File name
Adv SmPC bAB 7_0 IE-clean.pdf
Reasons for updating
- 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
The SPC has been updated as follows:
Section 4.5 has been updated with details of concomitantly administration of Abrysvo and COVID-19 vaccine.
Updated on 13 January 2025
File name
Adv SmPC bAB 6_0 IE-clean.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 August 2024
File name
Adv SmPC bAB 5_0 IE-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 July 2024
File name
Adv PIL IE NI MT bAB 3_0-clean.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 24 July 2024
File name
Adv SmPC bAB 4_0 IE-clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- 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
The SPC IE and SPC NI has been updated as follows:
Shelf-life update in section 6.3, new packsize in section 6.5 and and new license number in section 8. Updated revision date in section 10.
Updated on 23 July 2024
File name
AdvSmPCbAB30IEclean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- 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
The SPC IE and SPC NI has been updated as follows:
Shelf-life update in section 6.3 and minor typographical amendment to section 5.1. Updated revision date in section 10.
Updated on 22 July 2024
File name
Adv SmPC bAB 4_0 IE-clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- 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
The SPC IE and SPC NI has been updated as follows:
Shelf-life update in section 6.3, new packsize in section 6.5 and and new license number in section 8. Updated revision date in section 10.
Updated on 01 May 2024
File name
Adv SmPC bAB 30 IE clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- 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 20 March 2024
File name
Adv SmPC bAB 20 IE clean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- 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)
Updated on 20 March 2024
File name
Adv PIL IE bAB 20 clean.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 20 February 2024
File name
Adv SmPC IE bAB 1_0.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 February 2024
File name
Adv SmPC IE bAB 1_0.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 February 2024
File name
Adv SmPC IE bAB 1_0.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 February 2024
File name
Adv SmPC IE bAB 1_0.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 February 2024
File name
Adv PIL IE NI MT bAB 1_0.pdf
Reasons for updating
- New PIL for new product
Pfizer Healthcare Ireland Unlimited Company
Address:
The Watermarque Building, Ringsend Road, Dublin 4, D04 K7N3, IrelandTelephone:
+353 1 467 6500Fax:
+353 1 467 6501Website:
https://www.pfizermedicalinformation.ie/Medical Information Direct Line:
1 800 633 363