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Comirnaty 3 micrograms/dose concentrate for dispersion for injection

*
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):

    Tozinameran

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

Updated on 08 December 2023

File name

Adv SPC COMIRNATY 3mcg TSbCY 13 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 3mcg TS bCY 12 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

AdvSPCCOMIRNATY3mcgTSbCY120IENIclean.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

AdvSPCCOMIRNATY3mcgTSbCY120IENIclean.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

AdvPILCOMIRNATY3mcgTSbCY110IENIclean.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 30 August 2023

File name

Adv SPC COMIRNATY 3 mcg TSb CY 11_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 4.6 - Pregnancy and lactation
  • 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 30 August 2023

File name

Adv PIL COMIRNATY 3 mcg TSb CY 10_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 3 mcg TSb CY 9_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 3 mcg TSb CY 10_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 3 mcg TSb CY 9_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 3 mcg TS bCY 9_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 3 mcg TS bCY 8_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 3mcg TS bCY 80 IE NI clean.pdf

Reasons for updating

  • 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 08 March 2023

File name

Adv SPC COMIRNATY 3mcg TSbCY 70 IENIclean.pdf

Reasons for updating

  • 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 08 March 2023

File name

Adv PIL COMIRNATY3mcgTS bCY70 IENIclean.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 06 February 2023

File name

Adv SPC COMIRNATY3mcg TS bCY 6_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 COMIRNATY3mcg TS bCY 6_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 05 December 2022

File name

Adv SPC COMIRNATY 3mcg TS bCY 5_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 3mcg TS bCY 5_0 IE Clean.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 28 November 2022

File name

Adv SPC COMIRNATY 3mcg TS bCY 4_0 IEClean.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 3mcg TS bCY 4_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 3mcg TS bCY 3_0 IEclean.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 16 November 2022

File name

Adv PIL COMIRNATY 3mcg TS bCY 3_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 3mcg TS bCY 2_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 PIL COMIRNATY 3mcg 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 3 - how to take/use
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 24 October 2022

File name

AdvSPC COMIRNATY 3mcg TSb CY 1_0 IECLEAN.pdf

Reasons for updating

  • New SPC for new product

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

Updated on 24 October 2022

File name

AdvPIL COMIRNATY 3mcg TSb CY 1_0 IE CLEAN.pdf

Reasons for updating

  • New PIL for new product