Comirnaty 10 micrograms/dose concentrate for dispersion for injection *
Pharmacy Only: Prescription

Updated on 02 August 2022

File name

62e96dcc5e43b.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

62e96d999122f.pdf

Reasons for updating

  • Change to date of revision

Updated on 28 July 2022

File name

62e29e9e5f629.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

62e29e3e3f4fb.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 09 May 2022

File name

6278eccc4b908.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

6278ec7438cf7.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 06 April 2022

File name

Adv SPC COMIRNATY10 TS bCY 7_0 IE Clean_1649250928.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)

Free text change information supplied by the pharmaceutical company

The SPCs  have been updated as follows:

6.3  Shelf life – Increase of shelf life from 9 months to 12 months for all formulations and transportation details updated for the Tris-Sucrose formulation only.

 

6.6  Special precautions for disposal and other handling – Diagrams updated to provide further clarification.

Updated on 06 April 2022

File name

Adv PIL COMIRNATY10 TS bCY 7_0 IE Clean_1649250823.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 03 March 2022

File name

Adv SPC COMIRNATY10 TS bCY 6_0 IE Clean_1646314499.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)

Free text change information supplied by the pharmaceutical company

The SPCs  have been updated as follows:

4.2   Posology and method of administration – Section updated with primary course vaccination and booster dose in individuals 12 years and older (PBS only). Subsection on Elderly population updated to remove statement on safety and immunogenicity.

4.4   Special warnings and precautions for use – Subsection on General recommendation updated to provide clarity on the use of Comirnaty and anaphylaxis.

4.8   Undesirable effects – Section updated with data from Study 4

5.1   Pharmacodynamic properties –Immunogenicity in participants 18 years of age and older – after booster dose updated with booster dose data. Corrections to typographic errors. New subsection on Relative vaccine efficacy in participants 16 years of age and older – after booster dose included based on current data (PBS only)

6.6  Special precautions for disposal and other handling – Diagrams updated to provide further clarification.

Updated on 03 March 2022

File name

Adv PIL COMIRNATY10 TS bCY 6_0 IE Clean_1646314390.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 3 - how to take/use
  • Change to section 4 - possible side effects
  • 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 February 2022

File name

Adv SPC COMIRNATY10 TS bCY 5_0 IE Clean_1645621556.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

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:

4.6  Fertility, pregnancy and lactation – Section updated with data to support use of Comirnaty during pregnancy and breastfeeding

Updated on 23 February 2022

File name

Adv PIL COMIRNATY10 TS bCY 5_0 IE clean_1645621494.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 07 February 2022

File name

Adv SPC COMIRNATY10 TS bCY 4_0 IE Clean_1644253475.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

The SPC  has been updated as follows:

4.8   Undesirable effects – Subsection on Adolescents 12 to 15 years of age – after 2 doses updated with safety study data.

5.1   Pharmacodynamic properties – Subsection on Efficacy and immunogenicity in adolescents 12 to 15 years of age – after 2 doses  updated with efficacy analysis

6.3  Shelf life – deletion of -25 °C to -15 °C storage conditions

Updated on 07 February 2022

File name

Adv PIL COMIRNATY10 TS bCY 4_0 IE Clean_1644253351.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 26 January 2022

File name

Adv SPC COMIRNATY10 TS bCY 3_0 IE Clean_1643184184.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

The SPC  has been updated as follows:

4.4   Special warnings and precautions for use – Sub-section on anxiety-related reactions updated to include paraesthesia and hypoaesthesia.

4.8   Undesirable effects – updated to include paraesthesia and  hypoaesthesia under  Not known frequency category.

Updated on 26 January 2022

File name

Adv PIL COMIRNATY10 TS bCY 3_0 IE Clean_1643184134.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 14 December 2021

File name

Adv SPC COMIRNATY10 TS bCY 2_0 IE Clean_1639473670.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 6.3 - Shelf life
  • 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)

Free text change information supplied by the pharmaceutical company

The SPC  has been updated as follows:

4.4   Special warnings and precautions for use – Administrative update to subsection on myocarditis and pericarditis.

4.8   Undesirable effects – ADR frequency for Myocarditis and Pericarditis moved from unknown to very rare.

6.3  Shelf life – Update to 9 month shelf life.6.6     Special precautions for disposal and other handling - Update to 9 month shelf life.

9.   DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Renewal date added.

Updated on 14 December 2021

File name

Adv PIL COMIRNATY10 TS bCY 2_0 IE Clean_1639473568.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 14 December 2021

File name

Adv SPC COMIRNATY10 TS bCY 1_0 IE Clean_1639469189.pdf

Reasons for updating

  • New SPC for new product

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

Updated on 14 December 2021

File name

Adv PIL COMIRNATY10 TS bCY 1_0 IE Clean_1639469087.pdf

Reasons for updating

  • New PIL for new product