Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1650518
Name of medicinal product: ADASUVE
Active substances:
Loxapine
Estonian, English, Latin
ATC code: N05AH01
Dosage form: inhalation powder, pre-dispensed
Route of administration: inhalation use
Strengh: 9,1mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: ADASUVE is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Ferrer Internacional S.A. 
Marketing authorization number: EU/1/13/816 
Marketing authorization issued on: February 25, 2013 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: January 23, 2018
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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