Comirnaty JN.1 10 micrograms/dose dispersion for injection Children 5 to 11 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 10mcg RTU 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
Updated on 09 January 2025
File name
Adv SPC COMIRNATY JN.1 10 mcg RTU MDV & SDV 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.
Note: This update does not impacte the 3 mcg presentataions.
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 10 mcg RTU MDV & SDV 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 10mcg RTU 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 17 October 2024
File name
Adv PIL COMIRNATY JN.1 10mcg RTU 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 10 mcg RTU MDV & SDV 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 10mcg RTU MDV & SDV bCY 1_0 IE & NI.pdf
Reasons for updating
- New PIL for new product