Fluenz Tetra nasal spray suspension * Pharmacy Only: Prescription
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 04 August 2022
File name
62ebe589a0261.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
Inserted text, Deleted text
[…]
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Reassortant influenza virus* (live attenuated) of the following four strains**:
A/Victoria/2570/2019 (H1N1)pdm09 ‑ like strain
(A/Victoria/1/2020, MEDI 340505) 107.0±0.5 FFU***
A/Cambodia/e0826360/2020 (H3N2) - like strain (A/Tasmania/503/2020, MEDI 339018) A/Darwin/9/2021 (H3N2) - like strain
(A/Norway/16606/2021, MEDI 355293)
107.0±0.5 FFU***
B/Washington/02/2019 ‑ like strain
(B/Washington/02/2019, MEDI 323797) B/Austria/1359417/2021 - like strain
(B/Austria/1359417/2021, MEDI 355292)
107.0±0.5 FFU***
B/Phuket/3073/2013 ‑ like strain
(B/Phuket/3073/2013, MEDI 306444) 107.0±0.5 FFU***
.................................................................................................................per 0.2 ml dose
[…]
This vaccine complies with the WHO recommendation (Northern Hemisphere) and EU decision for the 20212/20223 season.
[…]
10. DATE OF REVISION OF THE TEXT
23rd July 2021 27 July 2022
Updated on 04 August 2022
File name
62ebe3c612d33.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
Inserted text, Deleted text
[…]
6. Contents of the pack and other information
What Fluenz Tetra contains
The active substances are:
Reassortant influenza virus* (live attenuated) of the following four strains**:
A/Victoria/2570/2019 (H1N1)pdm09 ‑ like strain
(A/Victoria/1/2020, MEDI 340505) 107.0±0.5 FFU***
A/Cambodia/e0826360/2020 (H3N2) - like strain
(A/Tasmania/503/2020, MEDI 339018)A/Darwin/9/2021 (H3N2) - like strain
(A/Norway/16606/2021, MEDI 355293) 107.0±0.5 FFU***
B/Washington/02/2019 ‑ like strain
(B/Washington/02/2019, MEDI 323797)B/Austria/1359417/2021 - like strain
(B/Austria/1359417/2021, MEDI 355292) 107.0±0.5 FFU***
B/Phuket/3073/2013 ‑ like strain
(B/Phuket/3073/2013, MEDI 306444) 107.0±0.5 FFU***
..................................................................................................................per 0.2 ml dose
* propagated in fertilised hens' eggs from healthy chicken flocks.
** produced in VERO cells by reverse genetic technology. This product contains genetically modified organisms (GMOs).
*** fluorescent focus units.
This vaccine complies with the WHO (World Health Organisation) recommendations (Northern Hemisphere) and EU decision for the 20221/20232 season.
[…]
This leaflet was last revised in 071/2022.
[…]
INF 22 00030012
Updated on 04 February 2022
File name
20220128 PIL IE MT Fluenz MAH contact details update 21-22 INF 22 0003_No MIL_1643969814.pdf
Reasons for updating
- Change to section 6 - date of revision
- Improved presentation of PIL
Free text change information supplied by the pharmaceutical company
Deleted text
6. Contents of the pack and other information
[…]
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
AstraZeneca AB
SE-151 85
Södertälje
Sweden
Manufacturer:
AstraZeneca Nijmegen B.V.,
Lagelandseweg 78
Nijmegen, 6545CG
Netherlands
[…]
This leaflet was last revised in 01/202207/2021.
Updated on 28 July 2021
File name
20210723 SPC IE MT Fluenz Annual Strain Change 21-22 INF 21 0026_1627470417.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
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Reassortant influenza virus* (live attenuated) of the following four strains**:
A/Guangdong-Maonan/SWL1536/2019
(A/Hawaii/66/2019, MEDI 326775
A/Hong Kong/2671/2019
(A/Hong Kong/2671/2019, MEDI 325078
B/Washington/02/2019 ‑ like strain
(B/Washington/02/2019, MEDI 323797) 107.0±0.5 FFU***
B/Phuket/3073/2013 ‑ like strain
(B/Phuket/3073/2013, MEDI 306444) 107.0±0.5 FFU***
.................................................................................................................per 0.2 ml dose
* propagated in fertilised hens’ eggs from healthy chicken flocks.
** produced in VERO cells by reverse genetic technology. This product contains genetically modified organisms (GMOs).
*** fluorescent focus units.
This vaccine complies with the WHO recommendation (Northern Hemisphere) and EU decision for the 2020/2021
[...]
10. DATE OF REVISION OF THE TEXT
27th July 2020
Updated on 28 July 2021
File name
20210723 PIL IE MT Fluenz Annual Strain Change 21-22 INF 21 0027_No MIL_1627470155.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to date of revision
Free text change information supplied by the pharmaceutical company
6. Contents of the pack and other information
What Fluenz Tetra contains
The active substances are:
Reassortant influenza virus* (live attenuated) of the following four strains**:
A/Guangdong-Maonan/SWL1536/2019
(A/Hawaii/66/2019, MEDI 326775
A/Hong Kong/2671/2019
(A/Hong Kong/2671/2019, MEDI 325078
B/Washington/02/2019 ‑ like strain
(B/Washington/02/2019, MEDI 323797) 107.0±0.5 FFU***
B/Phuket/3073/2013 ‑ like strain
(B/Phuket/3073/2013, MEDI 306444) 107.0±0.5 FFU***
..................................................................................................................per 0.2 ml dose
* propagated in fertilised hens' eggs from healthy chicken flocks.
** produced in VERO cells by reverse genetic technology. This product contains genetically modified organisms (GMOs).
*** fluorescent focus units.
This vaccine complies with the WHO (World Health Organisation) recommendations (Northern Hemisphere) and EU decision for the 2020/2021
[...]
This leaflet was last revised in 07/20210.
Updated on 21 May 2021
File name
20210503 PIL IE MT Fluenz Tetra Batch release site change INF 21 0016 No MIL_1621599041.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Red text = deleted, green text = added
6. Contents of the pack and other information
...
Marketing Authorisation Holder and Manufacturer
...
Manufacturer:
MedImmune Pharma AstraZeneca Nijmegen B.V.,
Lagelandseweg 78
Nijmegen, 6545CG
Netherlands
...
This leaflet was last revised in 07/2020 05/2021
Updated on 06 August 2020
File name
20200727 PIL IE Fluenz Tetra Annual Strain Change INF 20 0001 MIL Removed_1596710014.pdf
Reasons for updating
- New PIL for new product
Updated on 06 August 2020
File name
20200727 SPC IE Fluenz Tetra Annual Strain Change INF 20 0003_1596709761.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)