NASONEX Nasal Spray, Suspension Ref.[7526] Active ingredients: Mometasone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

Product name and form

NASONEX 50 micrograms/actuation Nasal Spray, Suspension.

Pharmaceutical Form

Nasal Spray, Suspension.

White to off-white opaque suspension.

Qualitative and quantitative composition

Mometasone furoate (as the monohydrate) 50 micrograms/actuation.

Excipient with known effect: This medicinal product contains 0.02 mg of benzalkonium chloride per actuation.

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.

List of Excipients

Dispersable cellulose (microcrystalline cellulose and carmellose sodium)
Glycerol
Sodium citrate
Citric acid monohydrate
Polysorbate 80
Benzalkonium chloride
Purified water

Pack sizes and marketing

NASONEX Nasal Spray is contained in a white, high density polyethylene bottle, that contains 10 g (60 actuations) or 18 g (140 actuations) of product formulation, supplied with a metered-dose, manual polypropylene spray pump actuator.

Pack sizes:

10 g, 1 bottle.
18 g, 1, 2 or 3 bottles.

Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

Marketing authorization dates and numbers

PL 00025/0587

10 April 1997 / 5 March 2008

Drugs

Drug Countries
NASONEX Austria, Brazil, Canada, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Japan, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, United Kingdom, United States, South Africa

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