Comirnaty 30micrograms/dose concentrate for dispersion for injection * Pharmacy Only: Prescription
Company:
Pfizer Healthcare IrelandStatus:
No Recent UpdateLegal 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 30 August 2023
File name
64ef5d6c1a8c0.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 30 August 2023
File name
64ef5cde7adfe.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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)
Updated on 10 August 2023
File name
64d4d37c0e48a.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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)
Updated on 10 August 2023
File name
64d4d2f3796f6.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 20 July 2023
File name
64b96e19ce5e9.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 20 July 2023
File name
64b96de9446e4.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 15 March 2023
File name
6411ea9747459.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 March 2023
File name
64088e7d54c23.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 08 March 2023
File name
64088e3fcee72.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 March 2023
File name
6408899d923a0.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 March 2023
File name
64088921debf5.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 06 February 2023
File name
63e11f0303119.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 February 2023
File name
63e11e9e012d1.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 23 December 2022
File name
63a58db95629a.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
Update to shelf life from 12 months to 18 months.
Updated on 23 December 2022
File name
63a58d6225a76.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 28 November 2022
File name
6384e28d10e6b.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 November 2022
File name
6384e258ceac4.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 16 November 2022
File name
637513933b65b.pdf
Reasons for updating
- 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)
Updated on 16 November 2022
File name
6375136151a34.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 07 November 2022
File name
636926e2428cd.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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)
Updated on 07 November 2022
File name
636926a894d94.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 25 October 2022
File name
6358237a0aa33.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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)
Updated on 25 October 2022
File name
635822eb8cb05.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 11 October 2022
File name
63453f4c1d107.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 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
4.4 Special warnings and precautions for use
Update to sections on myocarditis and pericarditris; removal of statement on risk.
4.8 Undesirable effects
Update to subsection on myocarditis and pericarditis; new statement added with respect to risk.
5.1 Pharmacodynamic properties
Deletion of paragraph on authorisation under a conditional approval scheme.
Updated on 11 October 2022
File name
63453ecca5e06.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
- Change to other sources of information section
- Change to information for healthcare professionals
Updated on 02 September 2022
File name
631203048e746.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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)
Updated on 02 September 2022
File name
63120233b9711.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 02 August 2022
File name
62e94d98a7e87.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 August 2022
File name
62e93346d6f08.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 02 August 2022
File name
62e9330d8065a.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 28 July 2022
File name
62e29fd7e1686.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 July 2022
File name
62e29f92bc100.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 09 May 2022
File name
6278ee114c114.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- 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)
Updated on 09 May 2022
File name
6278edc66a706.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 06 April 2022
File name
Adv SPC COMIRNATY30 PBS bCY 24_0 IE Clean_1649252003.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- 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:
6.3 Shelf life – Increase of shelf life from 9 months to 12 months for all formulations and transportation details updated for the Tris-Sucrose formulation only.
6.6 Special precautions for disposal and other handling – Diagrams updated to provide further clarification.
Updated on 06 April 2022
File name
Adv PIL COMIRNATY30 PBS bCY 23_0 IE Clean_1649251937.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 03 March 2022
File name
Adv SPC COMIRNATY30 PBS bCY 23_0 IE clean_1646314774.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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:
4.2 Posology and method of administration – Section updated with primary course vaccination and booster dose in individuals 12 years and older (PBS only). Subsection on Elderly population updated to remove statement on safety and immunogenicity.
4.4 Special warnings and precautions for use – Subsection on General recommendation updated to provide clarity on the use of Comirnaty and anaphylaxis.
4.8 Undesirable effects – Section updated with data from Study 4
5.1 Pharmacodynamic properties –Immunogenicity in participants 18 years of age and older – after booster dose updated with booster dose data. Corrections to typographic errors. New subsection on Relative vaccine efficacy in participants 16 years of age and older – after booster dose included based on current data (PBS only)
6.6 Special precautions for disposal and other handling – Diagrams updated to provide further clarification.
Updated on 03 March 2022
File name
Adv PIL COMIRNATY30 PBS bCY 22_0 IE clean_1646314670.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 23 February 2022
File name
Adv SPC COMIRNATY30 PBS bCY 22_0 IE clean_1645621384.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
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:
4.6 Fertility, pregnancy and lactation – Section updated with data to support use of Comirnaty during pregnancy and breastfeeding
Updated on 23 February 2022
File name
Adv PIL COMIRNATY30 PBS bCY 21_0 IE Clean_1645621303.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 07 February 2022
File name
Adv SPC COMIRNATY30 PBS bCY 21_0 IE Clean_1644253835.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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 SPC has been updated as follows:
4.8 Undesirable effects – Subsection on Adolescents 12 to 15 years of age – after 2 doses updated with safety study data.
5.1 Pharmacodynamic properties – Subsection on Efficacy and immunogenicity in adolescents 12 to 15 years of age – after 2 doses updated with efficacy analysis
6.3 Shelf life – deletion of -25 °C to -15 °C storage conditions
Updated on 07 February 2022
File name
Adv PIL COMIRNATY30 PBS bCY 20_0 IE Clean_1644253748.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 26 January 2022
File name
Adv SPC COMIRNATY30 PBS bCY 20_0 IE Clean_1643184057.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 COMIRNATY30 PBS bCY 19_0 IE Clean_1643183994.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 10 December 2021
File name
Adv PIL COMIRNATY30 PBS bCY 18_0 IE Clean (002)_1639138429.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 6 - date of revision
Updated on 10 December 2021
File name
Adv SPC COMIRNATY30 PBS bCY 19_0 IE Clean_1639137025.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 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.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Renewal date added.
Updated on 07 December 2021
File name
Adv SPC COMIRNATY10 TS bCY 1_0 IE Clean_1638861114.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 07 December 2021
File name
Adv PIL COMIRNATY10 TS bCY 1_0 IE Clean_1638860943.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Change to name of medicinal product
- Change to other sources of information section
- Change to information for healthcare professionals
Updated on 29 November 2021
File name
Adv SPC bCY 18_0 IE Clean_1638193151.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.3 - Shelf life
- 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 SPC has been updated as follows:
4.1 Therapeutic indications – Description of product updated to state: Comirnaty 30 micrograms/dose concentrate for dispersion for injection.
4.2 Posology and method of administration – Peadiatric subheading updated to include the following statement: There is a paediatric formulation available for children 5 to 11 years of age (i.e. 5 to less than 12 years of age). For details, please refer to the Summary of Product Characteristics for Comirnaty 10 micrograms/dose concentrate for dispersion for injection.
4.4 Special warnings and precautions for use – Administrative update to subsection on myocarditis and pericarditis.
6.3 Shelf life – section updated with; When stored frozen at -90 °C to -60 °C, 195‑vial packs of the vaccine can be thawed at 2 °C to 8 °C for 3 hours or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes.
6.6 Special precautions for disposal and other handling – section updated with new wording on handling instructions for the vaccine in 12 years and older.
Updated on 29 November 2021
File name
Adv PIL bCY 17_0 IE Clean_1638192981.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 19 November 2021
File name
Adv SPC bCY 17_0 IE Clean_1637314414.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 November 2021
File name
Adv PIL bCY 16_0 IE Clean_1637250590.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 05 November 2021
File name
Adv SPC bCY 16_0 IE Clean_1636107689.pdf
Reasons for updating
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 November 2021
File name
Adv PIL bCY 15_0 IE clean_1636107534.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 25 October 2021
File name
Adv SPC bCY 15_0 IE clean_1635177453.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- 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 SPC has been updated as follows:
1. NAME OF THE MEDICINAL PRODUCT – Updated with Comirnaty 30 micrograms/dose concentrate for dispersion for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION – Updated to include the new INN Tozinameran
4.2 Posology and method of administration – Statement on interchangeability updated
5.1 Pharmacodynamic properties – Updated to include the new INN Tozinameran
6.3 Shelf life – Subsection; Unopened vial updated to, “9 months when stored at -90 °C to -60 °C and statement added, Thawed vials can be handled in room light conditions”
6.4 Special precautions for storage - Thawed vials can be handled in room light conditions removed and moved under sec 6.3
6.5 Nature and contents of container – Revised with, “0.45 mL concentrate in a 2 mL clear multidose vial (type I glass) with a stopper (synthetic bromobutyl rubber) and a purple flip-off plastic cap with aluminium seal”
6.6 Special precautions for disposal and other handling – section introduced with new dose verification step and also updated with new diagrams and wording to reflect correct storage requirements
Updated on 25 October 2021
File name
Adv PIL bCY 14_0 IE Clean_1635177305.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 11 October 2021
File name
Adv PIL bCY 13_0 IE Clean_1633965467.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 11 October 2021
File name
Adv SPC bCY 14_0 IE Clean_1633965092.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- 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 SPC has been updated as follows:
4.2 Posology and method of administration - Section updated to include a third booster dose. New sub-section added to include third dose requirements on severely immunocompromised aged 12 and older. Elderly population subsection updated with safety and immunogenicity of a booster dose. 4.4 Special warnings and precautions for use- Statement added; “The risk of myocarditis after a third dose of Comirnaty has not yet been characterised”. Subsection on Immunocompromised individuals updated with recommendation of a third booster. 4.8 Undesirable effects- Section updates with overall safety profile for the booster dose. 5.1 Pharmacodynamic properties – section updated to include Immunogenicity in participants 18 years of age and older – after booster dose (third dose)
|
Updated on 27 September 2021
File name
Adv SPC bCY 13_0 IE clean_1632725372.pdf
Reasons for updating
- 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 SPC has been updated as follows:
4.8 Undesirable effects – Section updated with new data. Inclusion of side effects for decreased appetite, lethargy, Hyperhidrosis; Night sweats and asthenia
5.1 Pharmacodynamic properties – section updated to include new data on vaccine efficacy.
Updated on 27 September 2021
File name
Adv PIL bCY 12_0 IE clean_1632725323.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 14 September 2021
File name
Adv SPC bCY 12_0 IE clean_1631617774.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
6.3 Shelf life
Unopened vial
Frozen vial
9 months at ‑90 °C to ‑60 °C
Within the 9‑month shelf‑life unopened vials may be stored and transported at ‑25 °C to ‑15 °C for a single period of up to 2 weeks and can be returned to ‑90 °C to ‑60 °C.
Updated on 14 September 2021
File name
Adv PIL bCY 11_0 IE clean_1631617682.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 23 July 2021
File name
Adv SPC bCY 11_0 IE Clean_1627046581.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 – Subheading on Anxiety updated: Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions (e.g. dizziness, palpitations, increases in heart rate, alterations in blood pressure, tingling sensations and sweating) may occur in association with the vaccination process itself. Stress-related reactions are temporary and resolve on their own. Individuals should be advised to bring symptoms to the attention of the vaccination provider for evaluation. It is important that precautions are in place to avoid injury from fainting.
4.8 Undesirable effects Section update to include Extensive swelling of vaccinated limb; Facial swelling as unknown ADRs. |
Updated on 23 July 2021
File name
Adv PIL bCY 10_0 IE Clean_1627046469.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 6 - date of revision
Updated on 19 July 2021
File name
Adv SPC bCY 10_0 IE clean_1626714404.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 – New subheading on Myocarditis and pericarditis added with the following text:
Very rare cases of myocarditis and pericarditis have been observed following vaccination with Comirnaty. These cases have primarily occurred within 14 days following vaccination, more often after the second vaccination, and more often in younger men. Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general.
Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination.
Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition.
4.8 Undesirable effects
Section update to include Myocarditis and Pericarditis as unknown ADRs.
Updated on 13 July 2021
File name
Adv SPC bCY 10_0 IE clean_1626165855.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)
Updated on 13 July 2021
File name
Adv PIL bCY 9_0 IE clean_1626165772.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 6 - date of revision
Updated on 03 June 2021
File name
Adv SPC bCY 9_0 IE Clean_1622726094.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 SPC has been updated as follows:
4.1 Therapeutic indications – Updated to 12 years
4.2 Posology and method of administration - Updated to 12 years; subsection on paediatric population edited to paediatric participants
4.8 Undesirable effects – Summary of safety profile updated to include adolescent data; new subsection added with data for adolescents 12 to 15 years of age;
5.1 Pharmacodynamic properties – Subsection on efficacy updated; Table 2 updated with correct language and new data; new subsection of efficacy and immunogenicity in adolescents 12 to 15 years of age added
Updated on 03 June 2021
File name
Adv PIL bCY 8_0 IE Clean_1622725977.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - use in children/adolescents
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 19 May 2021
File name
Adv SPC bCY 8_0 IE Clean_1621426290.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- 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)
Updated on 19 May 2021
File name
Adv PIL bCY 7_0 IE Clean_1621426215.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 21 April 2021
File name
Adv SPC bCY 7_0 IE Clean_1619012036.pdf
Reasons for updating
- 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
Var II update to section 4.8 of SPC and consequential update to the PIL
Updated on 21 April 2021
File name
Adv PIL bCY 6_0 IE Clean_1619011946.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 29 March 2021
File name
Adv SPC bCY 5_0 IE clean_1617017552.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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Var II update to section 6.3, 6.4 and 6.6 with Storage of product at -20°C.
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Updated on 29 March 2021
File name
Adv PIL bCY 4_0 IE clean (002)_1617017328.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 26 February 2021
File name
Adv SPC bCY 5_0 IE clean_1614345863.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 February 2021
File name
Adv PIL bCY 4_0 IE clean (002)_1614345847.pdf
Reasons for updating
- New PIL for new product