Comirnaty JN.1 30 micrograms/dose dispersion for injection Adults and adolescents from 12 years
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
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
Updated on 09 January 2025
File name
Adv PIL COMIRNATY JN.1 30mcg MDV & SDV bCY 3_0 IE.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
The Marketed PILs has been updated to reflect the SPC changes.
Updated on 09 January 2025
File name
Adv SPC COMIRNATY JN.1 30mcg bCY 3_0 IE.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- 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
The SPCs have been updated as follows:
4.4 Special warnings and precautions for use
Information for immunocompromised individuals update based on final results from study C4591024, listed as a category 3 study in the RMP.
4.6 Fertility, pregnancy and lactation
Pregnancy related information update based on final results from study C4591015, listed as a category 3 study in the RMP.
4.8 Undesirable effects
Information for immunocompromised individuals update based on final results from study C4591024, listed as a category 3 study in the RMP. Pregnancy related information update based on final results from study C4591015, listed as a category 3 study in the RMP.
5.1 Pharmacodynamic properties
Information for immunocompromised individuals update based on final results from study C4591024, listed as a category 3 study in the RMP. Pregnancy related information update based on final results from study C4591015, listed as a category 3 study in the RMP.
Updated on 17 October 2024
File name
Adv SPC COMIRNATY JN.1 30mcg bCY 2_0 IE & NI.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 October 2024
File name
Adv PIL COMIRNATY JN.1 30mcg MDV & SDV bCY 2_0 IE & NI.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 05 July 2024
File name
Adv SPC COMIRNATY JN.1 30mcg bCY 1_0 IE & NI.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
New SPCs to reflect the new Pfizer/BNT Marketing Authorisation
Updated on 05 July 2024
File name
Adv PIL COMIRNATY JN.1 30mcg MDV & SDV bCY 1_0 IE & NI.pdf
Reasons for updating
- New PIL for new product