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 28 March 2025
File name
Adv SPC COMIRNATY JN.1 10 mcg & 30mcg bCY 7_0 IE clean.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.9 - Overdose
- 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:
4.9 Overdose
Section updated based on study C4591048 SSB+SSD interim reports and post-marketing overdose data
3. PHARMACEUTICAL FORM
Section updated to appropriately reflect the correct appearance “clear to slightly opalescent dispersion” of the 3-multidose (yellow cap) vials for Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection & Comirnaty KP.2 3 micrograms/dose concentrate for dispersion for injection.
6.6 Special precautions for disposal and other handling
Section updated to appropriately reflect the correct appearance “clear to slightly opalescent dispersion” of the 3-multidose (yellow cap) vials for Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection & Comirnaty KP.2 3 micrograms/dose concentrate for dispersion for injection.
Updated on 21 March 2025
File name
Adv SPC COMIRNATY JN.1 10 mcg & 30mcg bCY 6_0 IE clean.pdf
Reasons for updating
- 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 SPCs have been updated as follows:
6.3 Shelf life
Section updated with Shelf life for the Glass pre-filled syringe from 8 months to 12 months.
Updated on 13 March 2025
File name
Adv SPC COMIRNATY JN.1 10 mcg & 30mcg bCY 6_0 IE clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 March 2025
File name
Adv PIL COMIRNATY JN.1 30mcg MDV & SDV bCY 5_0 IE.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Improved presentation of PIL
Free text change information supplied by the pharmaceutical company
The PIL has been updated to reflect the SPC changes.
Updated on 05 March 2025
File name
Adv SPC COMIRNATY JN.1 10 mcg & 30mcg bCY 5_0 IE.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
Combine/streamline the EU SmPC per “primary pharmaceutical form” of each international nonproprietary name (INN), thus reducing the total number of SmPCs down to six (06) SmPCs, while the current separate Labelling and Package Leaflets remain unchanged.
Minor editorial changes made.
Updated on 26 February 2025
File name
Adv PIL COMIRNATY JN.1 30mcg MDV & SDV bCY 4_0 IE clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The PIL has been updated to reflect the SPC changes
Updated on 26 February 2025
File name
Adv SPC COMIRNATY JN.1 30mcg bCY 4_0 IE clean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 SPCs have been updated as follows:
4.5 Interaction with other medicinal products and other forms of interaction
Section updated with Comirnaty co-administration with:
o pneumococcal conjugate vaccine (PCV) in individuals 18 years of age and older.
o unadjuvanted recombinant protein respiratory syncytial virus (RSV) vaccine in individuals 18 years of age and older.
o unadjuvanted recombinant protein RSV vaccine and a high dose quadrivalent influenza vaccine (QIV) in individuals 65 years of age and older.
4.8 Undesirable effects
Section updated with Comirnaty co-administration with:
• unadjuvanted recombinant protein RSV vaccine and a high dose quadrivalent influenza vaccine (QIV) in individuals 65 years of age and older.
• unadjuvanted recombinant protein respiratory syncytial virus (RSV) vaccine in individuals 18 years of age and older.
• pneumococcal conjugate vaccine (PCV) in individuals 18 years of age and older.
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
Pfizer Healthcare Ireland Unlimited Company
Address:
The Watermarque Building, Ringsend Road, Dublin 4, D04 K7N3, IrelandTelephone:
+353 1 467 6500Fax:
+353 1 467 6501Website:
https://www.pfizermedicalinformation.ie/Medical Information Direct Line:
1 800 633 363