Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection, Adults and adolescents from 12 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 COMIRNATY BA.4-5 (15-15) TS bCY 18_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 COMIRNATY BA.4-5 (15-15 mcg) TS bCY 18_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 10 July 2024
File name
Adv SPC COMIRNATY BA.4-5 (15-15) TS bCY 17_0 IE & NI clean (1).pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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)
Updated on 04 July 2024
File name
Adv SPC COMIRNATY BA.4-5 (15-15) TS bCY 17_0 IE & NI clean (1).pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 6.6 - Special precautions for disposal and other handling
- 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.
For Comirnaty Tris 30mcg, Comirnaty original BA 4/5 (15-15) and Comirnaty Omicron XBB.1.5 30mcg
4.5 Interaction with other medicinal products and other forms of interaction
Section updated to include co-administration with Flu vaccine.
4.8 Undesirable effects
Section updated to include safety data with conmcominat vaccine adiminstration.
For Comirnaty Omicron XBB.1.5 30mcg
6.3 Shelf life
Section updated to include shelf life conditions for Glass PFS.
6.4 Special precautions for storage
Section updated with storage conditions
6.5 Nature and contents of container
Section updated to include glass PFS description
6.6 Special precautions for disposal and other handling
Section updated to include glass PFS details
Updated on 04 July 2024
File name
Adv PIL COMIRNATY BA.4-5 (15-15 mcg) TS bCY 17_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 COMIRNATY BA.4-5 (15-15 mcg) TS bCY 16_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 08 December 2023
File name
A6EI3E7~.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
91P0004~.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
AdvSPCCOMIRNATYBA.4-5 (15-15) TS bCY.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
91P0002~.PDF
Reasons for updating
- Change to section 6 - date of revision
Updated on 30 August 2023
File name
Adv SPC COMIRNATY BA.4-5 (15-15) TS bCY 14_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.4-5 (15-15 mcg) TS bCY 13_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 BA.4-5 (15-15) TS bCY 13_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.4-5 (15-15 mcg) TS bCY 12_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 BA.4-5 (15-15) TS bCY 12_0 IE & NI clean.dpdf.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.4-5 (15-15 mcg) TS bCY 11_0 IE & NI clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 15 March 2023
File name
Adv SPC COMIRNATYBA.4-5 (15-15) TS bCY 11_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 March 2023
File name
AdvSPCCOMIRNATYBA.4-5 (15-15) TS bCY 10_0 IE & NI clean.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 COMIRNATY BA.4-5 (15-15 mcg) TS bCY 10_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 BA.4-5 (15-15) TS bCY 9_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.4-5 (15-15 mcg) TS bCY 9_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 20 December 2022
File name
AdvSPCCOMIRNATYBA.4-5 (15-15) 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 6.3 - Shelf life
- 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)
Free text change information supplied by the pharmaceutical company
The SPCs have been updated as follows:
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Section updated to include information on single dose vial.
4.2 Posology and method of administration
Section updated to include method of administration with single dose vials.
6.3 Shelf life
Section updated to include details on storage of single dose vials.
6.5 Nature and contents of container
Section updated to include details on the content of a single dose ial.
6.6 Special precautions for disposal and other handling
Section updated to include information on details and use of single dose vials.
Updated on 20 December 2022
File name
AdvPILCOMIRNATYBA.4-5 (15-15 mcg) TS bCY 8_0 IE Clean.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- 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 05 December 2022
File name
Adv PIL COMIRNATY BA.4-5 (15-15 mcg) TS bCY 7_0 IE Clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 05 December 2022
File name
Adv SPC COMIRNATY BA.4-5 (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.4-5 (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.4-5 (15-15) TS bCY 6_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 BA.4-5 (15-15 mcg) 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 BA.4-5 (15-15 mcg) TS bCY 5_0 IE Clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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.4-5 (15-15) 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 16 November 2022
File name
AdvPILCOMIRNATYBA.4-5 15-15 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 16 November 2022
File name
AdvPILCOMIRNATYBA.4-5 (5-5) TS bCY 1_0 IE Clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- 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 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- 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 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Change to name of medicinal product
- Change to other sources of information section
- Change to information for healthcare professionals
Updated on 07 November 2022
File name
Adv SPC COMIRNATY BA.4-5 15-15 mcg 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 SPC COMIRNATY BA.4-5 15-15 mcg TS bCY 4_0 IE Clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 07 November 2022
File name
Adv PIL COMIRNATY BA.4-5 15-15 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 BA.4-5 15-15 mcg TS bCY 3_0 IE clean.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 BA. 4-5 15-15 mcg TS bCY 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
AdvSPCCOMIRNATYBA.4-5 15-15 mcg 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 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
Update to sections on myocarditis and pericarditris; removal of statement on risk.
4.8 Undesirable effects
Update to subsection on myocarditis and pericarditis; new statement added with respect to risk.
5.1 Pharmacodynamic properties
Deletion of paragraph on authorisation under a conditional approval scheme.
Updated on 11 October 2022
File name
AdvPILCOMIRNATYBA.4-5 15-15 mcg 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 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 14 September 2022
File name
AdvSPCCOMIRNATYBA.4-5 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 14 September 2022
File name
AdvPILCOMIRNATYBA.4-5 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
New PIL for New Product