ADASUVE Inhalation powder Ref.[9809] Active ingredients: Loxapine

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Ferrer Internacional, S.A., Gran Vía Carlos III, 94, 08028- Barcelona, España

Product name and form

ADASUVE 9.1 mg inhalation powder, pre-dispensed.

Pharmaceutical Form

Inhalation powder, pre-dispensed (inhalation powder).

White device with a mouthpiece on one end and a pull-tab protruding from the other end.

Qualitative and quantitative composition

Each single-dose inhaler contains 10 mg loxapine and delivers 9.1 mg loxapine.

Active Ingredient Description
Loxapine

Loxapine binds with noradrenergic, histaminergic, and cholinergic receptors, and its interaction with these systems may influence the spectrum of its pharmacological effects. Loxapine is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder.

List of Excipients

None.

Pack sizes and marketing

The white inhaler (housing) is molded from a medical-grade polycarbonate.

Each inhaler is provided in a sealed, multilaminate aluminum foil pouch. ADASUVE 9.1 mg is supplied in a carton of 1 or 5 units.

Not all pack-sized may be marketed.

Marketing authorization holder

Ferrer Internacional, S.A., Gran Vía Carlos III, 94, 08028- Barcelona, España

Marketing authorization dates and numbers

EU/1/13/823/002 (5 single-dose inhalers)
EU/1/13/823/004 (1 single-dose inhaler)

Date of first authorisation: 20 February 2013

Drugs

Drug Countries
ADASUVE Austria, Estonia, Spain, Hong Kong, Croatia, Ireland, Lithuania, Poland, Romania, Turkey, United Kingdom, United States

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