Fluenz nasal spray suspension
*Company:
AstraZeneca Pharmaceuticals (Ireland) DACStatus:
UpdatedLegal 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 17 April 2025
File name
20250328 SPC IE MT Fluenz MAA Catch-up Non-Seasonal Change 2024-2025 INF 25 0001.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - Marketing authorisation number(s)
- 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
Administrative updates throughout.
Section 1. Name of the Medicinal Product updated.
Name of the medicinal product updated to remove ‘attenuated’.
Section 2. Qualitative and Quantitative Composition updated.
Section 3. Pharmaceutical From updated.
Section 4.1 Therapeutic indications updated.
Section 4.2 Posology and method of administration updated.
Section 4.3 Contraindications updated. Example of excipient removed.
Section 4.4 Special warnings and precautions for use updated. Subheadings added. Additional information provided for concurrent illness and chronic conditions. Additional information provided for immunocompromised individuals.
Section 4.5 Interaction with other medicinal products and other forms of interaction updated regarding live attenuated vaccines.
Section 4.6 Fertility, pregnancy and lactation updated.
Section 4.8 Undesirable effects – updated throughout. Frequency of exacerbation of symptoms of Leigh syndrome (mitochondrial encephalomyopathy) and Guillain‑Barré syndrome updated to ‘Not known’.
Section 4.9 Overdose updated.
Section 5.1 Pharmacodynamic properties updated.
Section 6.1 List of excipients updated.
Section 6.5 Nature and contents of container updated.
Section 6.6 Special precautions for disposal and other handling updated.
Section 8. Marketing Authorisation Number(s) updated.
Section 10. Date of Revision of the Text updated.
Updated on 17 April 2025
File name
20250328 Package Leaflet IE MT Fluenz MAA Catch-up Non-Seasonal Change 2024-2025 INF 25 0002.pdf
Reasons for updating
- 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 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- 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 - date of revision
- Change to other sources of information section
- Change to information for healthcare professionals
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
AstraZeneca Pharmaceuticals (Ireland) DAC
 DAC.webp)
Address:
College Business and Technology Park, Blanchardstown Road North, Dublin 15, D15 R925Medical Information E-mail:
mipqc.ireland@astrazeneca.comTelephone:
+353 1 609 7100Fax:
+353 1 686 5038Website:
https://contactazmedical.astrazeneca.comMedical Information Direct Line:
1800800899