Quadrivalent Influenza vaccine (split virion, inactivated)
*Company:
Sanofi PasteurStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 16 May 2024
File name
481_ie_smpc_Var II_annual strain change NH2024-2025-Clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 May 2024
File name
481_uk-ie_mock-up PIL 1pk_annual strain change 2024-2025.pdf
Reasons for updating
- 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
Updated on 17 August 2023
File name
481_uk-ie_pil_Var II_annual strain change NH2023-2024-CLEAN.pdf
Reasons for updating
- 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
Updated on 17 August 2023
File name
481_ie_smpc_Var II_annual strain change NH2023-2024-CLEAN.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 June 2022
File name
481_uk-ie_pil_DEH1949001II035_Var II_annual strain change NH2022-2023.pdf
Reasons for updating
- 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
Updated on 29 June 2022
File name
481_ie_smpc_DEH1949001II035_Var II_annual strain change NH2022-2023.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 11 August 2021
File name
481_ie_smpc_2021-05-21_DEH1949001II030_Var II_annual strain change NH2021-2022.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 5.2 - Pharmacokinetic properties
- Change to section 6.2 - Incompatibilities
- Change to section 10 - Date of revision of the text
- Change to section 12 - Instructions for preparation of radiopharmaceuticals
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 August 2021
File name
481_uk-ie_pil_2021-05-21_DEH1949001II030_Var II_annual strain change NH2021-2022 (1).pdf
Reasons for updating
- 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
Updated on 12 March 2021
File name
Clean 481_uk-ie_pil_2021-02-25_DEH1949001IA028_Var IAin Deletion of black symbol in the PI.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Updated on 12 March 2021
File name
481_ie_smpc_2021-02-25_DEH1949001IA028 _Var IAin Deletion of black symbol in the PI.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 January 2021
File name
481_ ie_smpc_2020-12-22_DEH1949001R01_Renewal Application 2020.pdf
Reasons for updating
- 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 03 September 2020
File name
481_ ie_smpc_Annual Strain Change Variation 2020-2021_Type II_2020-08-20.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- 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 03 September 2020
File name
481_uk-ie_pil_Annual Strain Change Variation 2020-2021_Type II_2020-08.pdf
Reasons for updating
- 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 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 05 May 2020
File name
481_uk-ie_pil_DEH1949001II020G VarII Update of PI and RMP.pdf
Reasons for updating
- 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 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 05 May 2020
File name
481_ ie_smpc_DEH1949001II020G VarII Update of PI and RMP.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- 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
|
Section: 1, 4.6, 4.8, 4.9, 5 and 10 of the SPC have been updated. |
Updated on 04 December 2019
File name
481_uk-ie_pil_Var IB UK distributor address change_2019-09-19.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
sections 6 & 10 updated - Change of UK distributor address
Updated on 08 August 2019
File name
ukie-pil-qiv-annualflustrainchange 19-20-clean.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 07 August 2019
File name
ie-spc-qiv-annualflustrainchange 19-20-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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
The SPC have been updated to reflect the strain composition for the 2019-2020 season flu vaccine.
Section 2 of the SPC has been updated to show the new strain composition for the 2019/2020 flu season.
Section 10 has been updated with the HPRA approval date for the strain change variation.
Wrong SPC uploaded initially heance reuploaded.
Updated on 07 August 2019
File name
uk-spc-qiv-annualflustrainchange 19-20-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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
The SPC have been updated to reflect the strain composition for the 2019-2020 season flu vaccine.
Section 2 of the SPC has been updated to show the new strain composition for the 2019/2020 flu season.
Section 10 has been updated with the HPRA approval date for the strain change variation.
Updated on 28 May 2019
File name
ukie-pil-qiv-maternalimmunisation_WS179_final.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 - pregnancy, breast feeding and fertility
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 28 May 2019
File name
ie-spc-qiv-maternalimmunisation_WS179_final.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 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
- 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
Maternal immunisation impacting sections 4.1, 4.2, 4.4, 4.6, 4.8, 5.1 and 10 of the SPC
Updated on 13 August 2018
File name
ukie-pil-qiv-annualflustrainchange18-19.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 13 August 2018
File name
ie-spc-qiv-annualflustrainchange18-19-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
Annual flu strain change NH 2018-19
Updated on 18 January 2018
File name
PIL_17218_770.pdf
Reasons for updating
- New PIL for new product
Updated on 18 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 January 2018
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
- Change to section 7 - Marketing authorisation holder
- 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
Therapeutic indication for active immunisation of adults and children has changed from 3 years and older to 6 months and older.
As a result of this major change, the following sections have been amended: section 4.1.Therapeutic indications; section 4.2. Posology and method of administration; section 4.8. Undesirable effects; section 5.1. Pharmacodynamic properties; section 7. Marketing Authorisation Holder and section 10. Date of Revision of the Text
Updated on 18 January 2018
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 05 January 2018
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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
Updated on 04 January 2018
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 17 July 2017
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
Updated on 14 July 2017
Reasons for updating
- New PIL for new product