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Fluad Quad

10 October 2019

The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).

More in-depth information about the evaluation will be available in the Australian Public Assessment Report (AusPAR) for a particular prescription medicine, which can be found on the AusPAR search page once published.

Australian prescription medicine decision summary

Summary of submission

Product name
Fluad Quad
Active ingredients
Inactivated quadrivalent influenza vaccine (surface antigen)
ATC codes
J07BB (Influenza vaccines)
Decision
Approved
Date of decision
24 September 2019
Date of entry onto ARTG
1 October 2019
ARTG numbers
316323, 313724
Black Triangle Scheme
No
Sponsor
Seqirus Pty Ltd (Australia)
Sponsor address
63 Poplar Rd, Parkville VIC 3052
Dose forms
Injection, suspension
Strength
60 µg haemagglutinin (HA)/0.5 mL
Other ingredients
MF59C.1 (a proprietary adjuvant): containing squalene, polysorbate 80, sorbitan trioleate, sodium citrate dihydrate, citric acid monohydrate and water for injections and the following excipients; Sodium chloride, Potassium chloride, Monobasic potassium phosphate, Dibasic sodium phosphate dehydrate, Magnesium chloride hexahydrate, Calcium chloride dehydrate and Water for injections.
Containers
Prefilled syringe (needle free) and prefilled syringe (with attached needle)
Pack sizes
1 and 10
Routes of administration
Intramuscular
Dosage

A single 0.5 mL dose should be administered by intramuscular injection, preferably into the deltoid muscle of the upper arm.

Annual revaccination is recommended because immunity declines during the year after vaccination and circulating strains of influenza virus change from year to year.

For further information refer to the Product Information.

What was approved?

Fluad Quad (inactivated quadrivalent influenza vaccine (surface antigen)) was approved for the following therapeutic use:

Active immunisation against influenza in persons 65 years of age and older.

What is this medicine and how does it work?

What was the decision based on?

What steps were involved in the decision process?

What post-market commitments will the sponsor undertake?

  1. The Fluad Quad European Union (EU)-Risk Management Plan (RMP) (version 1.0, dated 9 January 2019, data lock point 31 October 2018), with Australian Specific Annex (version 1.0, dated 17 January 2019), included with submission PM-2019-00120-1-2, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
    An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs). Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than 15 calendar months after the date of the approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.
    The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency’s Guideline on good pharmacovigilance practices (GVP) Module VII periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration. Each report must have been prepared within ninety calendar days of the data lock point for that report.
  2. Batch Release Testing and Compliance with the Certified Product Details It is a condition of registration that all independent batches of Fluad Quad imported into Australia are not released for sale until samples and the manufacturer’s release data have been assessed and the sponsor has received notification acknowledging release from the Laboratories Branch, TGA.
    For each independent batch of the product imported into Australia, the sponsor must supply the following:
    1. A completed Request for Release Form, available from vaccines@health.gov.au.
    2. Complete summary protocols for manufacture and QC, including all steps in production.
    3. At least 20 (twenty) doses of the first consignment of each batch of Fluad Quad with the Australian approved labels, PI and packaging
    4. At least 10 (ten) doses of any further consignment of each batch of Fluad Quad with the Australian approved labels, PI and packaging
    5. Certificate of Release from a regulatory agency acting for the country of origin such as an OMCL (if available).
    6. Any reagents, reference material and standards required to undertake testing, as requested by Laboratories Branch, TGA.

Distribution of each shipment of each batch of vaccine is conditional upon fulfilment of these conditions and receipt of a letter from the Laboratories Branch acknowledging release.

  1. Certified Product Details
    An electronic copy of the Certified Product Details (CPD) as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) https://www.tga.gov.au/guidance-7-certified-produc... should be provided upon registration of the therapeutic good. In addition, an updated CPD, for the above products incorporating the approved changes is to be provided within one month of the date of approval letter. A template for preparation of CPD for biological prescription medicines and Vaccines can be obtained from the TGA website https://www.tga.gov.au/form/certified-product-deta.... The CPD should be sent as a single bookmarked PDF document to vaccines@health.gov.au as soon as possible after registration/approval of the product or any subsequent changes as indicated above.
  2. For all injectable products the Product Information must be included with the product as a package insert.

Further information

The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found at: ARTG search.

Australian Public Assessment Reports (AusPARs) can be found at: AusPAR search.

The latest news and updates regarding therapeutic goods regulation can be found at: TGA news room.