Product Dossier
ZYAMIS
Product Dossier for ZYAMIS (midazolam, Clinect). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Clinect
- Active ingredient: midazolam
- Therapeutic area: Neurology
- Related brand: Midazolam-Baxter
- Related brand: HYPNOVEL
- Same area: GILENYA
- Same area: RIVOTRIL
What it is
ZYAMIS is a midazolam oromucosal solution supplied as a pre-filled oral syringe in four strengths: 2.5 mg/0.25 mL, 5 mg/0.5 mL, 7.5 mg/0.75 mL, and 10 mg/1 mL.
Approved indications
— Epilepsy in patients aged over 6 months at high risk of generalised convulsive status epilepticus.
PBS listing
ZYAMIS oromucosal solution is listed on the PBS in three strengths: 5 mg in 0.5 mL, 7.5 mg in 0.75 mL, and 10 mg in 1 mL single use pre-filled oral syringes. Each strength has 2 PBS items and is restricted to authority required. The ex-manufacturer price for each PBS item is A$120.00.
Regulatory history
ZYAMIS was first registered on the ARTG on 22 April 2022 for all four strengths. The Pharmaceutical Benefits Scheme Advisory Committee initially did not recommend ZYAMIS for epilepsy (generalised convulsive status epilepticus) in July 2022. Following this outcome, ZYAMIS was recommended by PBAC in November 2022 for epilepsy in patients aged over 6 months at high risk of status epilepticus.