Fluenz Tetra nasal spray suspension *

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/SWL1536/2019A/Victoria/2570/2019 (H1N1)pdm09 ‑ like strain

(A/Hawaii/66/2019, MEDI 326775A/Victoria/1/2020, MEDI 340505)                         107.0±0.5 FFU***

 

A/Hong Kong/2671/2019A/Cambodia/e0826360/2020 (H3N2) - like strain

(A/Hong Kong/2671/2019, MEDI 325078A/Tasmania/503/2020, MEDI 339018)          107.0±0.5 FFU***

 

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 2020/20212021/2022 season.

[...]

10.     DATE OF REVISION OF THE TEXT

 

27th July 202023rd July 2021

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/SWL1536/2019A/Victoria/2570/2019 (H1N1)pdm09 ‑ like strain

(A/Hawaii/66/2019, MEDI 326775A/Victoria/1/2020, MEDI 340505)                    107.0±0.5 FFU***

 

A/Hong Kong/2671/2019A/Cambodia/e0826360/2020 (H3N2) - like strain

(A/Hong Kong/2671/2019, MEDI 325078A/Tasmania/503/2020, MEDI 339018)     107.0±0.5 FFU***

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 2020/20212021/2022 season.

[...]

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)