Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine

*
Pharmacy Only: Prescription
  • Company:

    Pfizer Healthcare Ireland
  • Status:

    No Recent Update
  • Legal 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 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