Comirnaty KP.2 10 micrograms/dose dispersion for injection
*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 13 March 2025
File name
Adv SPC COMIRNATY KP.2 10 mcg & 30 mcg 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 KP.2 10 mcg RTU MDV & SDV bCY 3_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 KP.2 10 mcg & 30 mcg 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
The SPCs have been updated as follows:
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 09 January 2025
File name
Adv PIL COMIRNATY KP.2 10 mcg RTU MDV & SDV bCY 2_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 KP.2 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.
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 01 October 2024
File name
Adv SPC COMIRNATY KP.2 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 01 October 2024
File name
Adv PIL COMIRNATY KP.2 10 mcg RTU MDV & SDV bCY 1_0 IE & NI.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PILs to reflect the new Pfizer/BNT Marketing Authorisation
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