Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection, Adults and adolescents from 12 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 COMIRNATY XBB.1.5 30mcg bCY 6_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 XBB.1.5 30mcg bCY 6_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 COMIRNATY XBB.1.5 30mcg bCY 5_0 IE & NI clean.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 XBB.1.5 30mcg bCY 5_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 SPC COMIRNATY XBB.1.5 30mcg bCY 4_0 IE & NI clean.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 SPC NI Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection has been updated as follows:
1. NAME OF THE MEDICINAL PRODUCT
Updated to include description on PFS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Section updated to include PFS presentation
4.2 Posology and method of administration
Section updated to include PFS dose administration
6.3 Shelf life
Section updated to include PFS storage conditions
6.5 Nature and contents of container
Section updated to include PFS container description
6.6 Special precautions for disposal and other handling
Section updated to include PFS details
The PIL NI have been updated with administrative changes. See PIL tick list for PIL sections updated
Updated on 17 May 2024
File name
Adv PIL COMIRNATY XBB.1.5 30mcg bCY 4_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
91P0002~.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
ADVPIL~2.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
AdvSPCCOMIRNATYXBB.1.5 30mcg bCY 2_0.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
AdvSPCCOMIRNATYXBB.1.5 30mcg bCY 2_0.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
AdvSPCCOMIRNATYXBB.1.5 30mcg bCY 2_0.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
AdvSPCCOMIRNATYXBB.1.5 30mcg bCY 2_0.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
ADVPIL~5.PDF
Reasons for updating
- Change to section 6 - date of revision
Updated on 08 November 2023
File name
ADVPIL~5.PDF
Reasons for updating
- Change to section 6 - date of revision
Updated on 08 November 2023
File name
ADVPIL~5.PDF
Reasons for updating
- Change to section 6 - date of revision
Updated on 06 September 2023
File name
ADVPIL~1.PDF
Reasons for updating
- New PIL for new product
Updated on 04 September 2023
File name
ADVSPC~1.PDF
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)