Public Summary

Summary for ARTG Entry: 312690 RYALTRIS olopatadine 600 microgram/actuation and mometasone furoate 25 microgram/actuation nasal
spray bottle

ARTG entry for Medicine Registered

Sponsor Seqirus Pty Ltd

Postal Address 63 Poplar Road,PARKVILLE, VIC, 3052
Australia
ARTG Start Date 11/12/2019
Product category Medicine
Status Active
Approval area Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods
Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered
or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. RYALTRIS olopatadine 600 microgram/actuation and mometasone furoate 25 microgram/actuation nasal

Public Summary
spray bottle
Product Type Single Medicine Product Effective date 11/12/2019

Permitted Indications
Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

RYALTRIS is indicated for the treatment of symptoms associated with allergic rhinitis and rhinoconjunctivitis in patients 12 years of age and older.

Warnings

See Product Information and Consumer Medicine Information for this product
Additional Product information

Container information

Type Material Life Time Temperature Closure Conditions

Bottle HDPE 24 Months Store below 30 Not recorded Do not Freeze
degrees Celsius
Do not Refrigerate

Pack Size/Poison information

Pack Size Poison Schedule
56 doses per bottle (Starter pack) (S4) Prescription Only Medicine
240 doses per bottle (S4) Prescription Only Medicine
120 doses per bottle (S4) Prescription Only Medicine
56 doses per bottle (S4) Prescription Only Medicine
Components
1. RYALTRIS olopatadine 600 microgram/actuation and mometasone furoate 25 microgram/actuation nasal spray bottle

Dosage Form Spray, nasal

Route of Administration Nasal
Visual Identification Aqueous white homogenous suspension filled into a white opaque high
density polyethylene bottle, fitted with spray pump, nasal actuator and dust
cap.

Active Ingredients

mometasone furoate monohydrate 25.86 microgram/actuation

Page 1 of 2 Produced at 31.12.2019 at 06:09:06 AEDT

This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information
 olopatadine hydrochloride 665 microgram/actuation

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of 2 Produced at 31.12.2019 at 06:09:06 AEDT

This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information