Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Glenmark Pharmaceuticals s.r.o, Hvezdova 1716/2b, Prague 4, 140 78, Czech Republic
Ryaltris 25 micrograms/actuation+600 micrograms/actuation nasal spray, suspension.
| Pharmaceutical Form |
|---|
|
Nasal Spray, Suspension. White, homogeneous suspension. |
One delivered dose (the dose that leaves the actuator) contains mometasone furoate monohydrate equivalent to 25 microgram mometasone furoate and olopatadine hydrochloride equivalent to 600 micrograms olopatadine.
Excipient with known effect: Each actuation contains 0.02 mg benzalkonium chloride.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Mometasone |
Mometasone is a topical glucocorticoid with local anti-inflammatory properties. It is likely that much of the mechanism for the effects of mometasone lies in its ability to inhibit the release of mediators of the inflammatory cascade. |
|
| Olopatadine |
Olopatadine is a potent selective antiallergic/antihistaminic agent that exerts its effects through multiple distinct mechanisms of action. |
| List of Excipients |
|---|
|
Microcrystalline cellulose (E460) |
The nasal spray is contained in a white, high density polyethylene bottle supplied with a metered-dose, manual polypropylene spray pump actuator. The actuator is fitted with a HDPE purple cap.
Pack sizes:
1 bottle of 20 ml with 9 g suspension (56 actuations),
1 bottle of 20 ml with 18 g suspension (120 actuations)
1 bottle of 30 ml with 29 g suspension (240 actuations).
Not all pack sizes may be marketed.
Glenmark Pharmaceuticals s.r.o, Hvezdova 1716/2b, Prague 4, 140 78, Czech Republic
PA1543/002/001
Date of first authorisation: 16th July 2021
| Drug | Countries | |
|---|---|---|
| RYALTRIS | Ecuador, Ireland, Israel, Poland, Romania, United Kingdom |
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