BECLAZONE 100mg Pressurised inhalation, solution Ref.[28141] Active ingredients: Beclometasone

Source: Υπουργείο Υγείας (CY)  Revision Year: 2007  Publisher: George Petrou Ltd., 50, Areos Str, Latsia 2234, Nicosia, Cyprus

Product name and form

Beclazone 100 micrograms CFC Free Inhaler Pressurised Inhalation Solution.

Pharmaceutical Form

Pressurised Inhalation, Solution.

Pressurised container fitted with a metering valve and an actuator.

The colour of the actuator is brown with a beige dust cap.

Qualitative and quantitative composition

One metered dose contains 100 micrograms Beclometasone Dipropionate Anhydrous.

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

Ethanol anhydrous 99.5%
Norflurane (HFA 134a)

Pack sizes and marketing

Pressurised container fitted with a metering valve.

The can is of 19ml nominal capacity manufactured from aluminium with either a debossed or a plain base. The can opening is configured to accept 20mm valves. Each pack contains a single inhaler which supplies a minimum of 200 actuations.

Marketing authorization holder

George Petrou Ltd., 50, Areos Str, Latsia 2234, Nicosia, Cyprus

Marketing authorization dates and numbers

14683

14th November 1997 / 14th November 2002

Drugs

Drug Countries
BECLAZONE Cyprus, Estonia, Hong Kong, Ireland, New Zealand

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