CLENIL Pressurised inhalation solution

Active ingredients: Beclometasone

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 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
Authorization Dates

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

29/06/2006 / 11/10/12

Marketing authorization number:

PL 08829/0133

Drugs

Drug
Countries
Cyprus, Hong Kong, Singapore, United Kingdom