Fluenz Tetra 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
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 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)