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2 March 2020

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

Submission type
New chemical entity
Product name


Active ingredients
Baloxavir marboxil
ATC codes
Date of decision
21 February 2020
Date of entry onto ARTG
21 February 2020
Original publication date
2 March 2020
ARTG numbers
317240, 317241
Black Triangle Scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia
Roche Products Pty Limited
Sponsor address
30-34 Hickson Road, Sydney NSW 2000
Dose forms
Film coated tablet
20 mg, 40 mg
Other ingredients

Lactose monohydrate, Croscarmellose sodium, Povidone, Microcrystalline cellulose, Sodium stearylfumarate, Hypromellose, Purified talc, Titanium dioxide.

Each 20 mg tablet contains 77.9 mg of lactose monohydrate and each 40 mg tablet contains 155.8 mg of lactose monohydrate.

Blister pack
Pack sizes
Routes of administration

A single oral dose of Xofluza should be taken within 48 hours of symptom onset.

Adults and Adolescents (≥ 12 years of age)

The recommended dose of Xofluza depending on body weight is:
  • 40 kg to < 80 kg: 40 mg.
  • ≥ 80 kg: 80 mg

For further information refer to the Product Information.

Pregnancy category


Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.

Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.

What was approved?

Xofluza (baloxavir marboxil) was approved for the following therapeutic use:

Xofluza is indicated for the treatment of uncomplicated influenza in patients aged 12 years of age and older who have been symptomatic for no more than 48 hours and who are:

  • otherwise healthy, or
  • at high risk of developing influenza complications.

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?

  • Provide TGA with the Annual Reports regarding the Update on the Emergence of Resistance, up to December 2023.
  • Xofluza (Baloxavir marboxil) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Xofluza must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
  • The Xofluza Core-Risk Management Plan (RMP) (version 2.0, dated 27 March 2019, data lock point 11 March 2019), with Australian Specific Annex (version 1.0, dated 8 April 2019), included with submission PM-2019-01386-1-2, 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 this 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 this 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.

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.