Fluenz Tetra nasal spray suspension

*
Pharmacy Only: Prescription

Updated on 02 August 2023

File name

20230728 Package Leaflet IE MT Fluenz Annual Strain Change INF 23 0015.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Annual strain update. Removal of UK Northern Ireland from the pack (Removal of UK NI details from AE reporting section and local MAH representatives). Update to date of revision.

Updated on 02 August 2023

File name

20230728 SPC IE MT Fluenz Annual Strain Change INF 23 0014.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Annual update of strain. Removal of UK Northern Ireland from pack. Update to revision date.

Updated on 14 February 2023

File name

20230206 SPC IE MT NI Non-seasonal labelling change INF 23 0003.pdf

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

6.6    Special precautions for disposal and other handling

[...]

Check expiry date

Product must not be used afterbefore date on applicator label.


10.    DATE OF REVISION OF THE TEXT

6 February 2023 27 July 2022

Updated on 14 February 2023

File name

20230206 PIL IE MT NI Non-seasonal labelling change INF 23 0004.pdf

Reasons for updating

  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Change of revision date

Updated on 04 August 2022

File name

20220727 SPC IE MT NI Fluenz Annual Strain Change 22-23 INF 22 0011.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

20220727 Package Leaflet IE MT NI Fluenz Annual Strain Change 22-23 INF 22 0012_No MIL.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.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.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.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.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.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.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)