Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection, Adults and adolescents from 12 years

*
Pharmacy Only: Prescription
  • Company:

    Pfizer Healthcare Ireland Unlimited Company
  • Status:

    Updated
  • 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 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)