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 15 March 2023

File name

6411eb33ca79c.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

64088e0252982.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

64088de9001ca.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 06 February 2023

File name

63e12036f2bcb.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

63e11fec8d5c2.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

63a58c4514d7e.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

63a58a5d11a78.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 20 December 2022

File name

63a1d81ce4e52.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

63a1d7a727a82.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

6391f0a6d4346.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

638e191c6a24f.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

638e18e69b31f.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 28 November 2022

File name

6384e491b79c2.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

6384e4612e19e.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

637515b39216c.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

637514d93bd32.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

6369291c1beb0.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

636928e8aa325.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

6358275a9b182.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

635826c0a5e3f.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

634542a1498a5.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

6345424dd4c05.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

631204714e02c.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

6312037954fe8.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

62e96d31a948a.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

62e96cf8c6132.pdf

Reasons for updating

  • Change to date of revision

Updated on 28 July 2022

File name

62e29f55c34e4.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

62e29f3194010.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 09 May 2022

File name

6278eec80504f.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

6278ee8ecfea6.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_1649332969.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_1649332592.pdf

Reasons for updating

  • New SPC for new product

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