Comirnaty concentrate for dispersion for injection *

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

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 stressrelated 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

Var II update to section 6.3, 6.4 and 6.6 with Storage of product at -20°C.

 

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