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Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection, Adults and adolescents from 12 years

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Pharmacy Only: Prescription

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