ARTG Entry
RYALTRIS
ARTG entry for RYALTRIS (olopatadine, mometasone furoate), ARTG 473905 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Seqirus
- Active ingredient: olopatadine, mometasone furoate
- Therapeutic area: Respiratory
What it is
RYALTRIS is a nasal spray containing olopatadine 600 microgram/actuation and mometasone furoate 25 microgram/actuation.
Approved indications
— Treatment of symptoms associated with allergic rhinitis in patients 6 years of age and older. — Treatment of symptoms associated with rhinoconjunctivitis in patients 6 years of age and older.
Key safety warnings
RYALTRIS contains the preservative benzalkonium chloride, which may cause eye irritation and be deposited in or discolour soft contact lenses. Patients who wear soft contact lenses should remove their lenses prior to instilling the drops and should not reinsert their lenses until at least 15 minutes after instillation.
Regulatory history
RYALTRIS was first registered on the Australian Register of Therapeutic Goods on 11 December 2019. On 28 January 2022, the TGA approved an extension of indications for RYALTRIS, assessing its quality, non-clinical, and clinical data for use in patients 6 years of age and older. The evaluation concluded that the benefits outweighed the risks for the proposed expanded patient population. Additional ARTG registrations followed, with variants listed on 28 March 2025 and 6 May 2026.