Active-ingredient Dossier

Fingolimod Hydrochloride

Active-ingredient Dossier for Fingolimod Hydrochloride (sphingosine-1-phosphate receptor modulator). Australian brands, products, PBS listings, PBAC…

What is

Fingolimod Hydrochloride Fingolimod Hydrochloride is a sphingosine-1-phosphate receptor modulator.

Australian brands containing

Fingolimod Hydrochloride — GILENYA — FINGOLIMOD — FILOSIR — FYNEFTA — FINGOLIMOD DEVATIS — FINGOLIMOD SANDOZ — FINGOLIMOD-RZ — FINGOLIMOD-TEVA — FINGOLIS — FYNOD

Therapeutic areas

Fingolimod Hydrochloride is registered in neurology, with 21 brands containing the ingredient on the ARTG.

Sponsor landscape

Fingolimod Hydrochloride is marketed by 11 sponsors, including Arrotex Pharmaceuticals, Novartis Pharmaceuticals, Dr Reddys Laboratories, Sun Pharma, Accord Healthcare and Devatis.

PBS and regulatory activity

One brand containing Fingolimod Hydrochloride has a PBS-listed item, with the latest PBS schedule date of 1 May 2026. The latest PBAC outcome was recorded on 1 November 2024, and the latest AusPAR was issued on 19 January 2011.