ALVESCO 80 Pressurised inhalation, solution Ref.[6668] Active ingredients: Ciclesonide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: AstraZeneca UK Ltd., 600 Capability Green, Luton, LU1 3LU, UK.

Product name and form

Alvesco 80 Inhaler.

Pharmaceutical Form

Pressurised inhalation, solution.

Clear and colourless.

Qualitative and quantitative composition

1 actuation (delivered dose from the mouthpiece) contains 80 micrograms of ciclesonide.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Ciclesonide

Ciclesonide exhibits low binding affinity to the glucocorticoid-receptor. Once orally inhaled, ciclesonide is enzymatically converted in the lungs to the principal metabolite (C21-des-methylpropionyl-ciclesonide) which has a pronounced anti-inflammatory activity and is thus considered as the active metabolite.

List of Excipients

Norflurane (HFA-134a)
Ethanol, anhydrous

Pack sizes and marketing

The inhaler comprises a pressurised container made from aluminium and is sealed with a metering valve, mouthpiece, and cap.

30 metered actuations
60 metered actuations
120 metered actuations

Not all pack sizes may be marketed.

Marketing authorization holder

AstraZeneca UK Ltd., 600 Capability Green, Luton, LU1 3LU, UK.

Marketing authorization dates and numbers

PL 17901/0297

16 April 2004 / 24 February 2014

Drugs

Drug Countries
ALVESCO Austria, Australia, Brazil, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, United States, South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.