Comirnaty TS 30 micrograms/dose dispersion for injection

*
Pharmacy Only: Prescription
  • Company:

    Pfizer Healthcare Ireland
  • 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 23 May 2024

File name

Adv PIL COMIRNATY30 TS bCY 28_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 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 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

Adv SPC COMIRNATY 30 TSb CY 28 0 IE NIclean.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

Adv PIL COMIRNATY 30 TSb CY 27 0 IE NI clean.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

AdvSPCCOMIRNATY30TSbCY270IENIclean.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

AdvPILCOMIRNATY30TSbCY260IENIclean.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 30 August 2023

File name

Adv SPC COMIRNATY 30 TSb CY 26_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 30 TSb CY 25_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 18 August 2023

File name

Adv PIL COMIRNATY 30 TSb CY 24_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 10 August 2023

File name

Adv SPC COMIRNATY 30 TSb CY 25_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 30 TSb CY 24_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 - 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 - 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 20 July 2023

File name

Adv SPC COMIRNATY 30 TS bCY 24_0 IE NI 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 20 July 2023

File name

Adv PIL COMIRNATY 30 TS bCY 23_0 IE NI clean.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 15 March 2023

File name

Adv SPC COMIRNATY 30 TS bCY 230 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

Adv SPC COMIRNATY30 TS bCY 220IENIclean.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 COMIRNATY30 TS bCY 220 IENIclean.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 06 February 2023

File name

Adv SPC COMIRNATY30 TS bCY 21_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 COMIRNATY30 TS bCY 21_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 23 December 2022

File name

AdvPILCOMIRNATY30TSbCY200IEClean.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 23 December 2022

File name

AdvPILCOMIRNATY30PBSbCY330IEClean.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 20 December 2022

File name

AdvSPCCOMIRNATY30TSbCY200IEClean.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

AdvPILCOMIRNATY30TSbCY200IEClean.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 08 December 2022

File name

Adv SPC COMIRNATY 30 TS bCY 19_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 30 TS bCY 19_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 PIL COMIRNATY 30 TS bCY 19_0 IE Clean.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 28 November 2022

File name

Adv SPC COMIRNATY 30 TS bCY 18_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 30 TS bCY 18_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 30 TS bCY 17_0 IE Clean.pdf

Reasons for updating

  • 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 30 TS bCY 17_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 07 November 2022

File name

Adv SPC COMIRNATY 30 TS bCY 16_0 IEClean.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 30TS bCY 16_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 30 TS bCY 15_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 30 TS bCY 15_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

AdvSPCCOMIRNATY30TSbCY140IEClean.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

AdvPILCOMIRNATY30TSbCY140IEClean.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 02 September 2022

File name

Adv SPC COMIRNATY30 TS bCY 13_0 IE Clean.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 02 September 2022

File name

Adv PIL COMIRNATY30 TS bCY 13_0 IE Clean.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 02 August 2022

File name

Adv SPC COMIRNATY30 TS bCY 12_0 IE Clean.pdf

Reasons for updating

  • 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 02 August 2022

File name

Adv PIL COMIRNATY30 TS bCY 12_0 IE Clean.pdf

Reasons for updating

  • Change to date of revision

Updated on 28 July 2022

File name

Adv SPC COMIRNATY30 TS bCY 11_0 IE clean.pdf

Reasons for updating

  • 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 28 July 2022

File name

Adv PIL COMIRNATY30 TS bCY 11_0 IE clean.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 09 May 2022

File name

Adv SPC COMIRNATY30 TS bCY 10_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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 09 May 2022

File name

Adv PIL COMIRNATY30 TS bCY 10_0 IE Clean.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 07 April 2022

File name

Adv PIL COMIRNATY30 TS bCY 9_0 IE clean.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 April 2022

File name

Adv SPC COMIRNATY30 TS bCY 9_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)