Comirnaty LP.8.1 30 micrograms/dose dispersion for injection MDV
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)
Updated on 02 September 2025
File name
Adv SPC COMIRNATY LP.8.1 10 mcg & 30 mcg MDV bCY 2_0 IE clean.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC have been updated as follows:
6.5 Nature and contents of container
Introduction of new pack size – 1 pre-filled syringe
8. Marketing Authorisation Number (s)
Section updated with new MA number for 1 glass pre-filled syringe presentation.
Updated on 02 September 2025
File name
Adv PIL COMIRNATY LP.8.1 30 mcg MDV Frozen Vial bCY 2_0 IE clean.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 30 July 2025
File name
Adv SPC COMIRNATY LP.8.1 10 mcg & 30 mcg MDV bCY 1_0 IE.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 July 2025
File name
Adv PIL COMIRNATY LP.8.1 30 mcg MDV bCY 1_0 IE.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