Active-ingredient Dossier

Tacrolimus Monohydrate

Active-ingredient Dossier for Tacrolimus Monohydrate (immunosuppressive agent). Australian brands, products, PBS listings, PBAC outcomes — compiled by…

Brand: AZEMATOP
Brand: TACROGRAF
Brand: TACROLIMUS
Therapeutic area: Immunology
Therapeutic area: Dermatology

What is

Tacrolimus Monohydrate Tacrolimus Monohydrate is an immunosuppressive agent.

Australian brands containing Tacrolimus Monohydrate

— TACROLIMUS — AZEMATOP — TACROGRAF

Therapeutic areas

Tacrolimus Monohydrate is registered in Immunology (4 brands) and Endocrinology (2 brands).

Sponsor landscape

Tacrolimus Monohydrate is marketed by three sponsors: Arrotex Pharmaceuticals, Sandoz, and Accord Healthcare.

PBS and regulatory activity

One brand containing Tacrolimus Monohydrate has PBS-listed items, with the latest PBS schedule date of 1 May 2026. The latest PBAC outcome is dated 1 July 2025, with two brands having PBAC outcomes on record. No AusPAR has been published for this ingredient.