Comirnaty LP.8.1 10 micrograms/dose dispersion for injection MDV Children 5 to 11 years
*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 01 April 2026
File name
Adv PIL COMIRNATY LP.8.1 10mcg MDV bCY 2_0 IE clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Improved presentation of PIL
Free text change information supplied by the pharmaceutical company
The PILs have been updated with the new batch release site.
Updated on 23 March 2026
File name
Adv SPC COMIRNATY LP.8.1 10 mcg & 30 mcg MDV bCY 3_0 IE clean.pdf
Reasons for updating
- 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 SPCs have been updated as follows:
4.8 Undesirable effects
Section updated on data from Study C4591054 Substudy A and Substudy B (1MPD immunogenicity data from SSA and SSB and the 6MPD safety data from SSA and SSB).
5.1 Pharmacodynamic properties
Section updated on data from Study C4591054 Substudy A and Substudy B (1MPD immunogenicity data from SSA and SSB and the 6MPD safety data from SSA and SSB).
Updated on 20 October 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 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 10mcg 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