Comirnaty 3 micrograms/dose concentrate for dispersion for injection, Infants and children 6 months to 4 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 17 October 2024
File name
Adv SPC COMIRNATY3mcg TS bCY 16_0 IE & NI.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 October 2024
File name
Adv PIL COMIRNATY3mcg TS bCY 15_0 IE & NI.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 04 July 2024
File name
Adv SPC COMIRNATY3mcg TS bCY 15_0 IE & NI clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- 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 following changes to the labeling have been approved. Please refer to attached copies of labeling documentation for full details.
Please note that COMIRNATY is subject to additional monitoring and therefore an inverted black triangle has been added to the SPC, PIL and PI.
The SPCs have been updated as follows:
For All Licences
4.8 Undesirable effects
ADR section updated to remove the wording, "and include batch/Lot number if available"
6.3 Shelf life
Storage conditions updated.
6.4 Special precautions for storage
Updated with editorial changes.
6.5 Nature and contents of container
Updated with editorial changes.
10. DATE OF REVISION OF THE TEXT
Agency website corrected.
Updated on 04 July 2024
File name
Adv PIL COMIRNATY3mcg TS bCY 14_0 IE & NI clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 17 May 2024
File name
Adv PIL COMIRNATY3mcg TS bCY 13_0 IE & NI clean.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 16 May 2024
File name
Adv SPC COMIRNATY3mcg TS bCY 14_0 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 December 2023
File name
Adv SPC COMIRNATY 3mcg TSbCY 13 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
Adv PIL COMIRNATY 3mcg TS bCY 12 0 IE NI clean.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
AdvSPCCOMIRNATY3mcgTSbCY120IENIclean.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
AdvSPCCOMIRNATY3mcgTSbCY120IENIclean.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
AdvPILCOMIRNATY3mcgTSbCY110IENIclean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 30 August 2023
File name
Adv SPC COMIRNATY 3 mcg TSb CY 11_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 4.6 - Pregnancy and lactation
- 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 30 August 2023
File name
Adv PIL COMIRNATY 3 mcg TSb CY 10_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 18 August 2023
File name
Adv PIL COMIRNATY 3 mcg TSb CY 9_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 10 August 2023
File name
Adv SPC COMIRNATY 3 mcg TSb CY 10_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 3 mcg TSb CY 9_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 - 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 - 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 20 July 2023
File name
Adv SPC COMIRNATY 3 mcg TS bCY 9_0 IE NI 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 20 July 2023
File name
Adv PIL COMIRNATY 3 mcg TS bCY 8_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 3mcg TS bCY 80 IE NI 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)
Updated on 08 March 2023
File name
Adv SPC COMIRNATY 3mcg TSbCY 70 IENIclean.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)
Updated on 08 March 2023
File name
Adv PIL COMIRNATY3mcgTS bCY70 IENIclean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 06 February 2023
File name
Adv SPC COMIRNATY3mcg TS bCY 6_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 COMIRNATY3mcg TS bCY 6_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 05 December 2022
File name
Adv SPC COMIRNATY 3mcg TS bCY 5_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 3mcg TS bCY 5_0 IE Clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 28 November 2022
File name
Adv SPC COMIRNATY 3mcg TS bCY 4_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 3mcg TS bCY 4_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 3mcg TS bCY 3_0 IEclean.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 16 November 2022
File name
Adv PIL COMIRNATY 3mcg TS bCY 3_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 3mcg TS bCY 2_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 3mcg TS bCY 2_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 24 October 2022
File name
AdvSPC COMIRNATY 3mcg TSb CY 1_0 IECLEAN.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 October 2022
File name
AdvPIL COMIRNATY 3mcg TSb CY 1_0 IE CLEAN.pdf
Reasons for updating
- New PIL for new product