Quadrivalent Influenza vaccine (split virion, inactivated) *
Pharmacy Only: Prescription

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 11 August 2021

File name

481_ie_smpc_2021-05-21_DEH1949001II030_Var II_annual strain change NH2021-2022_1628673744.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)_1628673705.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_1615561094.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_1615558309.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_1609769298.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_1599146072.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_1599146005.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_1588685138.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_1588685019.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_1575458319.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_1565173711.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_1565173590.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_1565173162.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_1559038321.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_1559038033.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_1534151439.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_1534151618.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

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 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

  • 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

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

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

Change of MAH address from 2, avenue Pont Pasteur 69007 Lyon, France to 14 Espace Henry Vallée 69007 Lyon, France

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

None provided

Updated on 14 July 2017

Reasons for updating

  • New PIL for new product