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PRODUCT DETAIL

Zimbus Breezhaler 114 mikrogramov/46 mikrogramov/136 mikrogramov inhalačný prášok v tvrdých kapsulách

Code 5496D
MA number EU/1/20/1440/005
Product Form: plv icd 150(15x10x1)x114 µg/46 µg/136 µg (blis.PA/Al/PVC-Al-jednotk.d.) (multibal.) + 15 inh.
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
R03AL12 Indacaterol, glycopyrroinium bromide and mometasone
Shelf life: 30
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: 03.07.2020
Validity: 03.07.2025
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 08.09.2020
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