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AIRFLUSAL FORSPIRO
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1636477
Name of medicinal product:
AIRFLUSAL FORSPIRO
Active substances:
Salmeterol+Fluticasone
Estonian
,
English
,
Latin
ATC code:
R03AK06
Dosage form:
inhalation powder, pre-dispensed
Route of administration:
inhalation use
Strengh:
50mcg+250mcg
Amount in package:
60annus 2TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Asthma {Broncholind}is indicated in the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta-2-agonist or patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2-agonist. Chronic Obstructive Pulmonary Disease (COPD) {Broncholind}is indicated for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated May 5, 2021)
Package information leaflet (PIL):
EST
(last updated October 8, 2019)
Labelling:
(last updated March 20, 2017)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Sandoz Pharmaceuticals d.d.
Marketing authorization number:
858314
Marketing authorization issued on:
October 23, 2014
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Decentralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: November 28, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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