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

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

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