Fluenz Tetra nasal spray suspension *
Pharmacy Only: Prescription

Updated on 04 August 2022

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62ebe589a0261.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 - Date of revision of the text

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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/SWL1536/2019A/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)