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PRODUCT DETAIL

Xoterna Breezhaler 85 mikrogramov/43 mikrogramov inhalačný prášok v tvrdých kapsulách

Code 7451A
MA number EU/1/13/863/005
Product Form: plv icd 96 (4x24x1)+4 inhalátory (blis.PA/Al/PVC-Al-perf.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: Novartis Europharm Limited, Ireland
Therapeutic Class: 14 - BRONCHODILATANTIA, ANTIASTHMATICA
ATC:
R RESPIRATORY SYSTEM
R03 DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R03A ADRENERGICS, INHALANTS
R03AL Adrenergics in combinations with anticholinergics incl. triple combinations with corticosteroids
R03AL04 Indacaterol and glycopyrronium bromide
Shelf life: 24
Container: blister PA/Al/PVC/Al
Route of admin.: Inhalation use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10b fixed combination application
MA issued: 19.09.2013
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 21.06.2018
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