RHINOLAST Nasal spray Ref.[49937] Active ingredients: Azelastine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Product name and form

Rhinolast Nasal Spray.

Pharmaceutical Form

Nasal spray.

Qualitative and quantitative composition

Azelastine Hydrochloride 0.1% w/v.

Active Ingredient Description
Azelastine

Azelastine, a phthalazinone derivative is classified as a potent long-acting anti-allergic compound with selective H1 antagonist properties. An additional anti-inflammatory effect could be detected after topical ocular administration. Data from in vivo (pre-clinical) and in vitro studies show that azelastine inhibits the synthesis or release of the chemical mediators known to be involved in early and late stage allergic reactions e.g. leukotriene, histamine, PAF and serotonin.

List of Excipients

Hypromellose
Disodium edetate
Citric acid
Disodium phosphate dodecahydrate
Sodium chloride
Purified water

Pack sizes and marketing

Polyethylene bottle with polypropylene cap and polyethylene seal containing either 10 ml or 20 ml.

Glass bottle with screw closure and polypropylene seal containing 10 ml, 20 ml or 22 ml.

Glass bottle with pump attached containing 10 ml, 20 ml or 22 ml.

10 ml glass bottle with pump attached, containing 5 ml aqueous solution.

10 ml polyethylene bottle with polypropylene cap and polyethylene seal, containing 5 ml aqueous solution.

Marketing authorization holder

Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 46302/0140

14th August 2009

Drugs

Drug Countries
RHINOLAST Ireland, Israel, Malta, New Zealand, United Kingdom, South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.