Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
*Company:
Pfizer Healthcare IrelandStatus:
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 08 December 2023
File name
Adv SPC COMIRNATY BA 11515TSbCY 15 0 IE NIclean.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.8 - Undesirable effects
- 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 08 December 2023
File name
91P0003~.PDF
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 08 November 2023
File name
AdvSPCCOMIRNATYBA11515TSbCY140IENIclean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.8 Undesirable effects
Update with data from Study C4591001 Interim CSR 6MPD3 (12-15y) + Final CSR
Updated on 08 November 2023
File name
AdvSPCCOMIRNATYBA11515TSbCY140IENIclean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.8 Undesirable effects
Update with data from Study C4591001 Interim CSR 6MPD3 (12-15y) + Final CSR
Updated on 08 November 2023
File name
AdvSPCCOMIRNATYBA11515TSbCY140IENIclean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.8 Undesirable effects
Update with data from Study C4591001 Interim CSR 6MPD3 (12-15y) + Final CSR
Updated on 08 November 2023
File name
AdvSPCCOMIRNATYBA11515TSbCY140IENIclean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.8 Undesirable effects
Update with data from Study C4591001 Interim CSR 6MPD3 (12-15y) + Final CSR
Updated on 08 November 2023
File name
91P0000~.PDF
Reasons for updating
- Change to section 6 - date of revision
Updated on 30 August 2023
File name
Adv SPC COMIRNATY BA 1 15 15 TSb CY 13_0 IE NI Clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 30 August 2023
File name
Adv PIL COMIRNATY BA.1 (15-15) TS bCY 12_0 IE & NI Clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 10 August 2023
File name
Adv SPC COMIRNATY BA1 15 15 TSb CY 12_0 IE NI Clean.pdf
Reasons for updating
- 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
- 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 10 August 2023
File name
Adv PIL COMIRNATY BA.1 (15-15) TS bCY 11_0 IE & NI 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 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 20 July 2023
File name
Adv SPC COMIRNATY BA1 15 15 TS bCY 11_0 IE NIclean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 July 2023
File name
Adv PIL COMIRNATY BA.1 (15-15) TS bCY 10_0 IE & NI clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 15 March 2023
File name
Adv SPC COMIRNATY BA11515 TS bCY 100 IE NI 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 08 March 2023
File name
AdvSPCCOMIRNATYBA11515TSbCY90IENIclean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 March 2023
File name
Adv PIL COMIRNATYBA.1 (15-15) TS bCY 8_0 IE & NI clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 06 February 2023
File name
Adv SPC COMIRNATY BA1 (15-15) TS bCY 8_0 IE NI Clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 February 2023
File name
Adv PIL COMIRNATY BA.1 (15-15) TS bCY 8_0 IE NI Clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 08 December 2022
File name
Adv SPC COMIRNATY BA.1 (15-15) TS bCY 7_0 IE Clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 December 2022
File name
Adv SPC COMIRNATY BA.1 (15-15) TS bCY 7_0 IE Clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 December 2022
File name
Adv PIL COMIRNATY BA.1 (15-15) TS bCY 7_0 IE Clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 28 November 2022
File name
Adv SPC COMIRNATY BA 115 15 TS bCY 6_0 IEClean.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 28 November 2022
File name
Adv PIL COMIRNATY BA.1 (15-15) TS bCY 6_0 IE Clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 16 November 2022
File name
Adv SPC COMIRNATY BA1 (15-15 mcg) TS bCY 5_0 IE Clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 6.3 - Shelf life
- 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 16 November 2022
File name
Adv PIL COMIRNATY BA.1 (15-15 mcg) TS bCY 5_0 IE Clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 07 November 2022
File name
Adv SPC COMIRNATY BA.1 15-15mcg TS bCY 4_0 IE Clean.pdf
Reasons for updating
- 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 07 November 2022
File name
Adv PIL COMIRNATY BA1 1515 mcg TS bCY 4_0 IE Clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 25 October 2022
File name
Adv SPC COMIRNATY BA1 15-15 mcg TSb CY 3_0 IEclean.pdf
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 October 2022
File name
Adv PIL COMIRNATY BA1 15-15 mcg TSb CY 3_0 IE clean.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 11 October 2022
File name
AdvSPCCOMIRNATYBA11515mcgTSbCY20IEClean.pdf
Reasons for updating
- 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
4.4 Special warnings and precautions for use
Deletion of sentence “Individuals may not be fully protected until 7 days after their second dose of vaccine”.
5.1 Pharmacodynamic properties
Update to vaccine name to use “Comirnaty” in Table 2.
Updated on 11 October 2022
File name
AdvPILCOMIRNATYBA11515mcgTSbCY20IEClean (1).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
- Change to other sources of information section
- Change to information for healthcare professionals
Updated on 05 September 2022
File name
Adv SPC COMIRNATY BA1 15-15 mcg TS bCY 1_0 IE Clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
New SPC for new product
Updated on 05 September 2022
File name
Adv PIL COMIRNATY BA1 15-15 mcg TS bCY 1_0 IE Clean.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
PIL for new product dosage