BRONCHITOL Inhalation powder, hard capsule Ref.[8203] Active ingredients: Mannitol

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Pharmaxis Europe Limited, 108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Ireland

Product name and form

Bronchitol 40 mg inhalation powder, hard capsules.

Pharmaceutical Form

Inhalation powder, hard capsule.

Clear colourless hard capsules marked with ‘PXS 40 mg’ and containing white or almost white powder.

Qualitative and quantitative composition

Each hard capsule contains 40 mg mannitol.

Mean delivered dose per capsule is 32.2 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Mannitol

Mannitol is a naturally occurring sugar alcohol used clinically primarily for its osmotic diuretic properties.

List of Excipients

None.

Pack sizes and marketing

Aluminium/polyamide/PVC/aluminium blisters. Cartons containing 10 or 280 capsules for initial dose and treatment use respectively.

The initiation dose carton contains 1 blister (of 10 capsules) and one inhaler device.

The 2-week carton contains 28 blisters (of 10 capsules each) and two inhaler devices.

Marketing authorization holder

Pharmaxis Europe Limited, 108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Ireland

Marketing authorization dates and numbers

EU/1/12/760/001-002

Date of first authorisation: 13 April 2012
Date of latest renewal: 11 January 2017

Drugs

Drug Countries
BRONCHITOL Austria, Australia, Estonia, Spain, Croatia, Ireland, Lithuania, Poland, United Kingdom

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