CLENIL Pressurised inhalation solution Ref.[6402] Active ingredients: Beclometasone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, United Kingdom

Product name and form

Clenil Modulite 50 micrograms per actuation pressurised inhalation solution.

Pharmaceutical Form

Pressurised inhalation solution.

Clenil Modulite contains the new propellant HFA-134a and does not contain any chlorofluorocarbons (CFCs). The solution is clear and colourless.

Qualitative and quantitative composition

Beclometasone dipropionate 50 micrograms per metered (ex-valve) dose.

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

HFA-134a
Ethanol
Glycerol

Pack sizes and marketing

Clenil Modulite 50 is supplied in an aluminium canister fitted with a metering valve, actuator and dust cap.

Each inhaler delivers 200 actuations.

Marketing authorization holder

Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, United Kingdom

Marketing authorization dates and numbers

PL 08829/0133

29/06/2006 / 11/10/12

Drugs

Drug Countries
CLENIL Brazil, Cyprus, Hong Kong, Ireland, Italy, Romania, Singapore, Tunisia, United Kingdom, South Africa

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