OXIS Inhalation powder Ref.[27705] Active ingredients: Eformoterol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: AstraZeneca UK Ltd., 600 Capability Green, Luton, Bedfordshire, LU1 3LU, UK

Product name and form

Oxis Turbohaler 12, inhalation powder.

Pharmaceutical Form

Inhalation powder.

White powder.

Qualitative and quantitative composition

Each delivered dose (i.e. the dose leaving the mouthpiece) from Oxis Turbohaler 12 contains 9 micrograms formoterol fumarate dihydrate which is derived from a metered dose of 12 micrograms.

Excipient with known effect:

Lactose monohydrate 891 micrograms per delivered dose. See section 4.4.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Eformoterol

Formoterol is a predominantly selective β2-stimulator. Formoterol has bronchodilator activity in patients with reversible obstructive airway diseases. In humans formoterol is effective in the prophylaxis of bronchospasm induced by methacholine challenge.

List of Excipients

Lactose monohydrate (which contains milk proteins)

Pack sizes and marketing

Oxis Turbohaler is a multidose, inspiratory flow driven, dry powder inhaler. The inhaler is made of plastic parts (PP, PC, HDPE, LDPE, LLDPE, PBT).

Each inhaler contains 60 doses.

Each pack contains either 60 doses (1 inhaler), 3x60 doses (3 inhalers), 10x60 doses (10 inhalers), 18x60 doses (18 inhalers) or 20x60 doses (20 inhalers).

Not all pack-sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 17901/0153

10 March 2007

Drugs

Drug Countries
OXIS Austria, Australia, Cyprus, Germany, Estonia, Spain, Finland, Ireland, Italy, Japan, Malta, Netherlands, New Zealand, Poland, United Kingdom, South Africa

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