NASOBEC Nasal spray, suspension Ref.[49651] Active ingredients: Beclometasone

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands

Product name and form

Nasobec 50 Micrograms Aqueous Nasal Spray.

Pharmaceutical Form

Nasal spray, suspension.

A white opaque suspension, free from any visible matter.

Qualitative and quantitative composition

Each 100 mg spray contains 50 micrograms beclometasone dipropionate.

Excipients: contains benzalkonium chloride solution 0.02 microlitres.

For a 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

Benzalkonium chloride
Phenylethyl alcohol
Polysorbate 80
Glucose
Microcrystalline cellulose and Carmellose sodium
Hydrochloric acid
Purified water

Pack sizes and marketing

Nasobec is supplied in polyethylene bottles of 30 ml capacity containing a nominal 200 doses fitted with a metering pump with a built in nasal adaptor. Each bottle is designed to deliver a nominal 100 milligrams of suspension per spray.

Marketing authorization holder

Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands

Marketing authorization dates and numbers

PA1986/055/001

Date of first authorisation: 04 March 1999
Date of last renewal: 04 March 2009

Drugs

Drug Countries
NASOBEC Hong Kong, Ireland, Malta, United Kingdom

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