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PRODUCT DETAIL

Daxas 500 µg filmom obalené tablety

Code 21489
MA number EU/1/10/636/001
Product Form: tbl flm 10x500 µg (blis.PVC/PVDC/Al)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: AstraZeneca AB, Sweden
Therapeutic Class: 14 - BRONCHODILATANTIA, ANTIASTHMATICA
ATC:
R RESPIRATORY SYSTEM
R03 DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R03D OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R03DX Other systemic drugs for obstructive airway diseases
R03DX07 Roflumilast
Shelf life: 36
Container: blister PVC/PVDC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 05.07.2010
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 05.06.2020
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