BECONASE Aqueous suspension for intranasal inhalation Ref.[27911] Active ingredients: Beclometasone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Glaxo Wellcome UK Ltd., Trading as GlaxoSmithKline UK, 980 Great West Road, Brentford, Middlesex, TW8 9GS

Product name and form

Beconase Aqueous Nasal Spray.

Pharmaceutical Form

Aqueous suspension for intranasal inhalation via metered dose atomising pump.

Qualitative and quantitative composition

Beclometasone Dipropionate 50μg (as monohydrate, micronised).

Excipient with known effect: Benzalkonium Chloride.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Beclometasone

Beclometasone is a pro-drug with weak glucocorticoid receptor binding affinity. It is extensively hydrolysed via esterase enzymes to the active metabolite beclometasone-17-monopropionate (B-17-MP), which has potent topical anti-inflammatory activity.

List of Excipients

Avicel RC 591 (Microcrystalline Cellulose and Carboxymethylcellulose Sodium) US NF
Anhydrous Dextrose BP
Benzalkonium Chloride BP
Phenylethyl Alcohol USP
Polysorbate 80 BP
Purified Water BP

Pack sizes and marketing

A 25ml amber neutral glass bottle fitted with a metering atomising pump, or a 30ml polypropylene bottle fitted with a tamper-resistant metering atomising pump. The pumps are manufactured by: Valois S.A. Le Prieure BPG, 27110 Le Neubourg, France.

Pack size: 200 Metered Spray.

Marketing authorization holder

Glaxo Wellcome UK Ltd., Trading as GlaxoSmithKline UK, 980 Great West Road, Brentford, Middlesex, TW8 9GS

Marketing authorization dates and numbers

PL 10949/0104

12th April 2003

Drugs

Drug Countries
BECONASE France, Hong Kong, Ireland, Lithuania, Mexico, New Zealand, Tunisia, United Kingdom, United States

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