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13 December 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

Submission type
New chemical entity
Product name
Active ingredients
ATC codes
Date of decision
25 October 2019
Date of entry onto ARTG
1 November 2019
ARTG numbers
310498, 310499
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.
Novartis Pharmaceuticals Australia Pty Ltd
Sponsor address
54 Waterloo Rd, North Ryde NSW 2113
Dose forms
Film coated tablet
0.25 mg and 2 mg
Other ingredients

Tablet core

Lactose monohydrate, microcrystalline cellulose, crospovidone, glycerol dibehenate and colloidal anhydrous silica.

Each 0.25 mg tablet contains 62.2 mg lactose monohydrate.

Each 2 mg tablet contains 60.3 mg lactose monohydrate.

Tablet coating

Polyvinyl alcohol, titanium dioxide, iron oxide yellow (2 mg only), iron oxide red (0.25 mg and 2 mg), black iron oxide (0.25 mg only), purified talc, lecithin, xanthan gum.

Blister pack
Pack sizes

0.25 mg: 12 film coated tablets (titration pack) and 120 film coated tablets.

2 mg: 28 film coated tablets.

Routes of administration

Before initiation of treatment with Mayzent the CYP2C9 genotype of the patient should be determined. Mayzent should not be used in patients with a CYP2C9*3*3 genotype.

Treatment has to be initiated with a titration pack that lasts for 5 days. The dose titration starts with 0.25 mg once daily on day 1 and 2, followed by once daily doses of 0.5 mg on day 3 (two tablets of 0.25 mg), 0.75 mg on day 4 (three tablets of 0.25 mg), and 1.25 mg on day 5 (five tablets of 0.25 mg), to reach the maintenance dose of 2 mg* Mayzent starting on day 6. *The recommended maintenance dose is 1 mg daily for patients with CYP2C9 *2*3 or *1*3 genotype (for further information on maintenance dosing please see the Product Information). During the first 6 days of treatment initiation the recommended daily dose should be taken once daily in the morning with or without food.

For further information refer to the Product Information.

Pregnancy category

Category D

Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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?

Mayzent (siponimod) was approved for the following therapeutic use:

Mayzent is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS).

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?

  • Mayzent (Siponimod) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Mayzent 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 Mayzent (Siponimod) EU-Risk Management Plan (RMP) (version 1.1; date 18 March 2019; data lock point 31 December 2017), with Australian Specific Annex (version 2.0; date 17 June 2019), included with submission number PM-2018-04434-1-1, to be revised to the satisfaction of 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.