Comirnaty Omicron XBB.1.5 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 COMIRNATY XBB.1.5 3mcg Conc 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 3mcg Conc 10 doses 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 3mcg Conc bCY 5_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 COMIRNATY XBB.1.5 3mcg Conc 10 doses 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 16 May 2024
File name
Adv SPC COMIRNATY XBB.1.5 3mcg Conc bCY 4_0 IE & NI 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 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 16 May 2024
File name
Adv SPC COMIRNATY XBB.1.5 3mcg Conc bCY 4_0 IE & NI 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 6.5 - 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 16 May 2024
File name
Adv PIL COMIRNATY XBB.1.5 3mcg Conc 10 doses 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 07 March 2024
File name
Adv PIL COMIRNATY XBB.1.5 3mcg Conc bCY 3_0 IE & NI Clean.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL for New Product
Updated on 07 March 2024
File name
Adv SPC COMIRNATY XBB.1.5 3mcg Conc bCY 3_0 IE & NI 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