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PRODUCT DETAIL

Sirkava 18 mikrogramov

Code 9387C
MA number 14/0344/18-S
Product Form: plv icd 60x18 µg (blis.Al/Al/PVC+pomôc.NeumoHaler)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
Therapeutic Class: 14 - BRONCHODILATANTIA, ANTIASTHMATICA
ATC:
R RESPIRATORY SYSTEM
R03 DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R03B OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03BB Anticholinergics
R03BB04 Tiotropium bromide
Shelf life: 24
Route of admin.: Inhalation use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(3) hybrid application
MA issued: 12.10.2018
Validity: 12.10.2023
MA renewed: Renewal application submitted
SPC: SPC_Sirkava_08-2021.pdf  
PIL: PIL_Sirkava 18 mikrogramov_12/2023.pdf  
Safety feature Yes
Data update: 19.10.2018
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