Comirnaty 10 micrograms/dose concentrate for dispersion for injection Children 5 to 11 years
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
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 17 October 2024
File name
Adv SPC COMIRNATY10 TS bCY 28_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 COMIRNATY10 TS bCY 27_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 COMIRNATY10 TS bCY 27_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 COMIRNATY10 TS bCY 26_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 COMIRNATY10 TS bCY 25_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 COMIRNATY10 TS bCY 26_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 10 TSbCY 25 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 10 TSb CY 24 0 IE NIclean.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
AdvSPCCOMIRNATY10TSbCY240IENIclean.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
AdvSPCCOMIRNATY10TSbCY240IENIclean.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
AdvSPCCOMIRNATY10TSbCY240IENIclean.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
AdvPILCOMIRNATY10TSbCY230IENIclean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 30 August 2023
File name
Adv PIL COMIRNATY 10 TSb CY 22_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 30 August 2023
File name
Adv SPC COMIRNATY 10 TSb CY 23_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 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 SPC COMIRNATY 10 TSb CY 22_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 10 TSb CY 21_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 PIL COMIRNATY 10 TS bCY 20_0 IE NI clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 20 July 2023
File name
Adv SPC COMIRNATY 10 TSb CY 21_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 15 March 2023
File name
Adv SPC COMIRNATY 10 TS bCY 200 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 10TSbCY 190 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 COMIRNATY 10 TSbCY 190 IENIclean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 06 February 2023
File name
Adv SPC COMIRNATY10 TS bCY 18_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 COMIRNATY10 TS bCY 18_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 PIL COMIRNATY 10 TS bCY 17_0 IE Clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 05 December 2022
File name
Adv SPC COMIRNATY 10 TS bCY 17_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 10 TS bCY 17_0 IE Clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 28 November 2022
File name
Adv SPC COMIRNATY 10 TS bCY 16_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 28 November 2022
File name
Adv PIL COMIRNATY 10 TS bCY 16_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 10 TS bCY 15_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 16 November 2022
File name
Adv PIL COMIRNATY 10 TS bCY 15_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 10 TS bCY 14_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 10 TS bCY 14_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 10 TSb CY 13_0 IE clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 10 TSb CY 13_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
AdvSPCCOMIRNATY10TSbCY120IEClean.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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 October 2022
File name
AdvPILCOMIRNATY10TSbCY120IEClean.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 02 September 2022
File name
Adv SPC COMIRNATY10 TS bCY 11_0 IE clean.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 02 September 2022
File name
Adv PIL COMIRNATY10 TS bCY 11_0 IE Clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 02 August 2022
File name
Adv SPC COMIRNATY10 TS bCY 10_0 IE Clean.pdf
Reasons for updating
- 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 02 August 2022
File name
Adv PIL COMIRNATY10 TS bCY 10_0 IE Clean.pdf
Reasons for updating
- Change to date of revision
Updated on 28 July 2022
File name
Adv SPC COMIRNATY10 TS bCY 9_0 IE clean.pdf
Reasons for updating
- 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 28 July 2022
File name
Adv PIL COMIRNATY10 TS bCY 9_0 IE clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 09 May 2022
File name
Adv SPC COMIRNATY10 TS bCY 8_0 IE Clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- 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 09 May 2022
File name
Adv PIL COMIRNATY10 TS bCY 8_0 IE Clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 06 April 2022
File name
Adv SPC COMIRNATY10 TS bCY 7_0 IE Clean.pdf
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
The SPCs have been updated as follows:
6.3 Shelf life – Increase of shelf life from 9 months to 12 months for all formulations and transportation details updated for the Tris-Sucrose formulation only.
6.6 Special precautions for disposal and other handling – Diagrams updated to provide further clarification.
Updated on 06 April 2022
File name
Adv PIL COMIRNATY10 TS bCY 7_0 IE Clean.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 03 March 2022
File name
Adv SPC COMIRNATY10 TS bCY 6_0 IE 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)
Free text change information supplied by the pharmaceutical company
The SPCs have been updated as follows:
4.2 Posology and method of administration – Section updated with primary course vaccination and booster dose in individuals 12 years and older (PBS only). Subsection on Elderly population updated to remove statement on safety and immunogenicity.
4.4 Special warnings and precautions for use – Subsection on General recommendation updated to provide clarity on the use of Comirnaty and anaphylaxis.
4.8 Undesirable effects – Section updated with data from Study 4
5.1 Pharmacodynamic properties –Immunogenicity in participants 18 years of age and older – after booster dose updated with booster dose data. Corrections to typographic errors. New subsection on Relative vaccine efficacy in participants 16 years of age and older – after booster dose included based on current data (PBS only)
6.6 Special precautions for disposal and other handling – Diagrams updated to provide further clarification.
Updated on 03 March 2022
File name
Adv PIL COMIRNATY10 TS bCY 6_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 3 - how to take/use
- Change to section 4 - possible side effects
- 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 23 February 2022
File name
Adv SPC COMIRNATY10 TS bCY 5_0 IE Clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
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:
4.6 Fertility, pregnancy and lactation – Section updated with data to support use of Comirnaty during pregnancy and breastfeeding
Updated on 23 February 2022
File name
Adv PIL COMIRNATY10 TS bCY 5_0 IE clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 07 February 2022
File name
Adv SPC COMIRNATY10 TS bCY 4_0 IE Clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
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:
4.8 Undesirable effects – Subsection on Adolescents 12 to 15 years of age – after 2 doses updated with safety study data.
5.1 Pharmacodynamic properties – Subsection on Efficacy and immunogenicity in adolescents 12 to 15 years of age – after 2 doses updated with efficacy analysis
6.3 Shelf life – deletion of -25 °C to -15 °C storage conditions
Updated on 07 February 2022
File name
Adv PIL COMIRNATY10 TS bCY 4_0 IE Clean.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 26 January 2022
File name
Adv SPC COMIRNATY10 TS bCY 3_0 IE Clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
The SPC has been updated as follows:
4.4 Special warnings and precautions for use – Sub-section on anxiety-related reactions updated to include paraesthesia and hypoaesthesia.
4.8 Undesirable effects – updated to include paraesthesia and hypoaesthesia under Not known frequency category.
Updated on 26 January 2022
File name
Adv PIL COMIRNATY10 TS bCY 3_0 IE Clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 14 December 2021
File name
Adv SPC COMIRNATY10 TS bCY 2_0 IE Clean.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 6.3 - Shelf life
- 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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
4.4 Special warnings and precautions for use – Administrative update to subsection on myocarditis and pericarditis.
4.8 Undesirable effects – ADR frequency for Myocarditis and Pericarditis moved from unknown to very rare.
6.3 Shelf life – Update to 9 month shelf life.6.6 Special precautions for disposal and other handling - Update to 9 month shelf life.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Renewal date added.
Updated on 14 December 2021
File name
Adv PIL COMIRNATY10 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 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 14 December 2021
File name
Adv SPC COMIRNATY10 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)
Updated on 14 December 2021
File name
Adv PIL COMIRNATY10 TS bCY 1_0 IE Clean.pdf
Reasons for updating
- New PIL for new product