Fluenz nasal spray suspension
*Company:
AstraZeneca Pharmaceuticals (Ireland) DACStatus:
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 23 July 2024
File name
20240717 Package Leaflet IE MT Fluenz Annual Strain Change 24,25 INF 24 0007.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Change to Section 6 - what Fluenz contains, as follows:
Contents of the pack and other information
What Fluenz contains
The active substances are:
Reassortant influenza virus* (live attenuated) of the following strains**:
A/Victoria/4897/2022 (H1N1)pdm09 ‑ like strain (A/Norway/31694/2022, MEDI 369815)
A/Thailand/8/2022 (H3N2) ‑ like strain
(A/Thailand/8/2022, MEDI 370626)A/Darwin/9/2021 (H3N2) - like strain
(A/Norway/16606/2021, MEDI 355293)
B/Austria/1359417/2021 ‑ like strain
(B/Austria/1359417/2021, MEDI 355292
This vaccine complies with the WHO recommendation (Northern Hemisphere) and EU decision for the 20243/20254 season.
Change to date of revision
Updated on 23 July 2024
File name
20240717 SPC IE MT Fluenz Annual Strain Change 2425 INF 24 0006.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
Change to section 2 - Qualitative and quantitative composition as follows:
A/Victoria/4897/2022 (H1N1)pdm09 ‑ like strain (A/Norway/31694/2022, MEDI 369815)
A/Thailand/8/2022 (H3N2) ‑ like strain
(A/Thailand/8/2022, MEDI 370626)A/Darwin/9/2021 (H3N2) - like strain
(A/Norway/16606/2021, MEDI 355293)
B/Austria/1359417/2021 ‑ like strain
(B/Austria/1359417/2021, MEDI 355292
This vaccine complies with the WHO recommendation (Northern Hemisphere) and EU decision for the 20243/20254 season.
Updated on 11 June 2024
File name
20240603 SPC IE MT Fluenz MAA Trivalent INF 24 0004.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 Summary of Product Characteristics for Fluenz nasal spray suspension new MAA
Updated on 11 June 2024
File name
20240603 Package Leaflet IE MT Fluenz MAA Trivalent INF 24 0005.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New patient information leaflet for Fluenz nasal spray suspension new MAA