Comirnaty 10 micrograms/dose concentrate for dispersion for injection * Pharmacy Only: Prescription
Company:
Pfizer Healthcare IrelandStatus:
UpdatedLegal 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
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