PULMICORT TURBOHALER 100 Breath-actuated metered dose powder inhaler Ref.[49682] Active ingredients: Budesonide

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

Pulmicort Turbohaler 100.

Pharmaceutical Form

Breath-actuated metered dose powder inhaler.

Qualitative and quantitative composition

Budesonide 100 micrograms/actuation.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Budesonide

Budesonide is a glucocorticosteroid with a high local anti-inflammatory effect. At doses clinically equivalent to systemically acting glucocorticosteroids, budesonide gives significantly less HPA axis suppression and has a lower impact on inflammatory markers.

List of Excipients

Pulmicort Turbohaler contains only active drug, budesonide. There are no propellants, lubricants, preservatives, carrier substances or other additives.

Pack sizes and marketing

Polyethylene container consisting of a cover screwed onto a bottom plate. Inside this is the inhaler with its main parts: a mouthpiece, a dosing mechanism and a substance store.

The device also contains a desiccant.

100 micrograms/actuation. 200 actuations.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 17901/0162

Date of first authorisation: 20th November 1991
Date of latest renewal: 4th May 2006

Drugs

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

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