natgillin/translations-raw huggingface dataset:
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS DEVICE LABEL 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Prepare a dose Wait to open the cover until you are ready to take your dose. 
Pokrovček odprite šele, ko ste pripravljeni, da vzamete odmerek.
Talk to your doctor before you use Relvar Ellipta: if you have liver disease, as you may be more likely to have side effects. 
Svojemu zdravniku morate povedati, če imate med jemanjem zdravila Relvar Ellipta kar koli od naslednjega, ker so to lahko simptomi okužbe pljuč:
This corresponds to a pre-dispensed dose of 100 micrograms of fluticasone furoate and 25 micrograms vilanterol (as trifenatate). 
To ustreza odmerjenemu odmerku 100 mikrogramov flutikazonfuroata in 25 mikrogramov vilanterola (v obliki trifenatata).
This corresponds to a pre-dispensed dose of 200 micrograms of fluticasone furoate and 25 micrograms vilanterol (as trifenatate). 
To ustreza odmerjenemu odmerku 200 mikrogramov flutikazonfuroata in 25 mikrogramov vilanterola (v obliki trifenatata).
• flu (influenza) 
• okužba obnosnih votlin (sinusov) ali žrela, • gripa (influenca),
In an integrated analysis of the two replicate one year studies in moderate to severe COPD (mean predicted post-bronchodilator screening FEV1 of 45%, standard deviation (SD) 13%) with an exacerbation in the preceding year (n = 3255), the number of pneumonia events per 1000 patient years was 97.9 with FF/VI 
V integrirani analizi dveh repliciranih enoletnih študij pri zmerni do hudi KOPB (povprečni predvideni FEV1 po bronhodilatatorju ob presejanju 45 %, standardni odklon 13 %) s poslabšanjem v predhodnem letu (n = 3255) je bilo število pljučnic na 1000 bolnik-let v skupini s FF/VI 184/22 97,9, v skupini s FF/VI 92/22 85,7
Nasopharyngitis Paradoxical bronchospasm Oropharyngeal pain Sinusitis 
Bolezni dihal, prsnega koša in mediastinalnega prostora nazofaringitis paradoksni bronhospazem orofaringealna bolečina sinuzitis faringitis rinitis kašelj disfonija zelo pogosti redki pogosti
There was no evidence for gender, weight or BMI (body mass index) to influence the pharmacokinetics of fluticasone furoate based on a population pharmacokinetic analysis of phase III data in 1213 subjects with asthma (712 females) and 1225 subjects with COPD (392 females). 
Populacijska farmakokinetična analiza podatkov III. faze pri 1213 preiskovancih z astmo (712 žensk) in
FF/VI 92/22 Once Daily vs placebo Once Daily Change from Baseline in Trough FEV1 Last Observation Carried Forward (LOCF) Treatment difference P value (95% CI) 
Sprememba najnižjega FEV1 od izhodišča, prenos zadnjega opažanja (LOCF - last observation carried forward) Razlika zdravljenj Vrednost p (95 % IZ)
Multipacks contain 3 x 30 dose inhalers. 
Pakiranje Relvar Ellipta z več inhalatorji vsebuje 3 inhalatorje s 30 odmerki.
The primary efficacy endpoint was change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at the end of the treatment period. 
Primarni opazovani dogodek učinkovitosti je bila sprememba najnižjega FEV1 glede na izhodišče na kliničnem obisku
Asthma-related adverse events and exacerbations may occur during treatment with fluticasone furoate/vilanterol. 
Med zdravljenjem s flutikazonfuroatom/vilanterolom se lahko pojavijo z astmo povezani neželeni učinki in poslabšanja.
Each delivered dose contains 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate). 
En dostavljen odmerek vsebuje 184 mikrogramov flutikazonfuroata in 22 mikrogramov vilanterola (v obliki trifenatata).
The 24-hour bronchodilator effect of fluticasone furoate/vilanterol was maintained from the first dose throughout a one-year treatment period with no evidence of loss in efficacy (no tachyphylaxis). 
24-urni bronhodilatacijski učinek flutikazonfuroata/vilanterola se je ohranil od prvega odmerka skozi celotno enoletno obdobje zdravljenja,
Interaction with beta-blockers 
Medsebojno delovanje z antagonisti adrenergičnih receptorjev beta
Prior to run-in, subjects discontinued use of previous COPD medications except short-acting bronchodilators. 
KOPB razen kratkodelujočih bronhodilatatorjev.
These include: beta-blockers, such as metoprolol, used to treat high blood pressure or a heart condition. 
Med takšnimi so: - antagonisti adrenergičnih receptorjev beta, npr. metoprolol, ki se uporablja za zdravljenje visokega krvnega tlaka ali bolezni srca, - ketokonazol za zdravljenje glivičnih okužb, - ritonavir ali kobicistat za zdravljenje okužb z virusom HIV,
Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations), Harmire Road, 
Glaxo Operations UK Ltd. (posluje kot Glaxo Wellcome Operations) Harmire Road
Each delivered dose contains 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate). 
En dostavljen odmerek vsebuje 92 mikrogramov flutikazonfuroata in 22 mikrogramov vilanterola (v obliki trifenatata).
There were no clinically relevant effects of the fluticasone furoate/vilanterol combination on beta-adrenergic systemic effects (heart rate or serum potassium) in subjects with mild or moderate hepatic impairment (vilanterol, 22 micrograms) or with severe hepatic impairment (vilanterol, 12.5 micrograms) compared with healthy subjects. 
Pri preiskovancih z blago ali zmerno okvaro jeter (22 mikrogramov vilanterola) ali s hudo okvaro jeter (12,5 mikrogramov vilanterola) v primerjavi z zdravimi preiskovanci ni bilo klinično pomembnih učinkov kombinacije flutikazonfuroata/vilanterola na sistemske beta-adrenergične učinke (srčna frekvenca ali kalij v serumu).
In a 12 week study (HZC113107) in COPD patients both fluticasone furoate/vilanterol 92/22 micrograms given once daily in the morning and salmeterol/FP 50/500 micrograms given twice daily, demonstrated improvements from baseline in lung function. 
V 12-tedenski študiji (HZC113107) pri bolnikih s KOPB so izboljšanje pljučne funkcije glede na izhodišče ugotovili tako s flutikazonfuroatom/vilanterolom 92/22 mikrogramov enkrat na dan zjutraj in kombinacijo salmeterola/FP 50/500 mikrogramov dvakrat na dan. Korigirano povprečno terapevtsko povečanje uteženega povprečja FEV1 0-24 ur glede na izhodišče je bilo s flutikazonfuroatom/vilanterolom 130 ml in s kombinacijo salmeterol/FP 108 ml; to kaže na celotno izboljšanje pljučne funkcije v 24-urnem obdobju z obema zdravljenjema.
What Relvar Ellipta looks like and contents of the pack The Ellipta device itself is a light grey inhaler with a yellow mouthpiece cover and a dose counter. 
Pripomoček Ellipta je svetlo siv inhalator z rumenim pokrovčkom ustnika in števcem odmerkov.
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate). 
Ena inhalacija zagotavlja oddani odmerek (odmerek, ki zapusti ustnik) 92 mikrogramov flutikazonfuroata in 22 mikrogramov vilanterola (v obliki trifenatata).
There was no increase in tumour incidence in rats or mice at exposures 2- or 30-fold, respectively, those at the maximum recommended human dose, based on AUC. 
Pri izpostavljenostih, ki so bile pri podganah 2-krat, pri miših pa 30-krat tolikšne kot so izpostavljenosti (na podlagi AUC) med uporabo največjega priporočenega odmerka za človeka, niso ugotovili večje incidence tumorjev.
It should not be used to relieve a sudden attack of breathlessness or wheezing. 
Zdravila Relvar Ellipta se ne sme uporabljati za olajšanje nenadnega napada zasoplosti ali piskajočega dihanja.
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate). 
Ena inhalacija zagotavlja oddani odmerek (odmerek, ki zapusti ustnik) 184 mikrogramov flutikazonfuroata in 22 mikrogramov vilanterola (v obliki trifenatata).
NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed 
IME ZDRAVILA Relvar Ellipta 92 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni
Your Relvar Ellipta inhaler carton contains 
Škatla vašega zdravila Relvar Ellipta vsebuje
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACK) 184/22 micrograms 
ŠKATLA (PAKIRANJE Z ENIM INHALATORJEM) 184/22 mikrogramov
NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed 
IME ZDRAVILA Relvar Ellipta 184 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni
Fluticasone furoate/vilanterol 92 /22 micrograms consistently demonstrated 83 mL to 95 mL improvements in trough FEV1 at weeks 12, 36 and 52 and Endpoint compared with FF 92 micrograms (p<0.001 95% CI 52, 126 mL at Endpoint). 
Flutikazonfuroat/vilanterol 92/22 mikrogramov je v primerjavi z 92 mikrogrami FF dosledno dosegal izboljšanje najnižjega FEV1 za 83 do 95 ml 12., 36. in 52. teden ter na končni točki študije (p < 0,001 95 %
Check with your doctor before you use this medicine if you think any of these applies to you. 
Če menite, da kaj od tega velja za vas, se posvetujte s svojim zdravnikom, preden uporabite to zdravilo.
Data from large asthma and COPD clinical trials were used to determine the frequency of adverse reactions associated with fluticasone furoate/vilanterol. 
Za ugotavljanje pogostnosti neželenih učinkov, povezanih s flutikazonfuroatom/vilanterolom, so bili uporabljeni podatki velikih kliničnih preskušanj pri astmi in KOPB.
Relvar Ellipta 184/22 micrograms should be considered for adults and adolescents 12 years and over who require a higher dose of inhaled corticosteroid in combination with a long-acting beta2-agonist. 
Za odrasle bolnike in mladostnike, stare 12 let ali več, ki potrebujejo višji odmerek inhaliranega kortikosteroida v kombinaciji z dolgodelujočim agonistom adrenergičnih receptorjev beta2, pride v poštev zdravilo Relvar Ellipta 184/22 mikrogramov.
In a 24 week study (HZA113091) in adult and adolescent patients with uncontrolled persistent asthma both fluticasone furoate/vilanterol 92/22 micrograms given once daily in the evening and salmeterol/FP 50/250 micrograms given twice daily demonstrated improvements from baseline in lung function. 
Študije v primerjavi s kombinacijami salmeterola/flutikazonpropionata V 24-tedenski študiji (HZA113091) pri odraslih in mladostnikih z neurejeno perzistentno astmo so izboljšanje pljučne funkcije glede na izhodišče dosegli tako s flutikazonfuroatom/vilanterolom 92/22 mikrogramov enkrat na dan zvečer kot s kombinacijo salmeterola/FP 50/250 mikrogramov dvakrat na dan. Korigirano povprečno terapevtsko povečanje uteženega povprečja FEV1 glede na izhodišče za 341 ml (flutikazonfuroat/vilanterol) in 377 ml (salmeterol/FP) kaže celotno izboljšanje pljučne funkcije v 24 urah z obema načinoma zdravljenja.
• patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta2-agonists. 
• bolniki, ki imajo bolezen ustrezno urejeno ob uporabi inhalacijskih kortikosteroidov in dolgodelujočih agonistov adrenergičnih receptorjev beta2.. 4.2 Odmerjanje in način uporabe
A starting dose of one inhalation of Relvar Ellipta 92/22 micrograms once daily should be considered for adults and adolescents 12 years and over who require a low to mid dose of inhaled corticosteroid in combination with a long-acting beta2-agonist. 
Za odrasle in mladostnike v starosti 12 let ali več, ki potrebujejo nizek do srednji odmerek inhaliranega kortikosteroida v kombinaciji z dolgodelujočim agonistom adrenergičnih receptorjev beta2, pride v poštev začetni odmerek ene inhalacije zdravila Relvar Ellipta 92/22 mikrogramov enkrat dnevno.
The recommended dose to treat asthma is one inhalation (92 micrograms of fluticasone furoate and 22 micrograms of vilanterol) once daily at the same time each day. 
Priporočeni odmerek za zdravljenje astme je ena inhalacija (92 mikrogramov flutikazonfuroata in
Inhale your medicine 
Vdihnite zdravilo.
Studies > 1 year duration 
6.3 Rok uporabnosti
There was no evidence for age to affect the pharmacokinetics of fluticasone furoate in subjects with COPD while there was an increase (37%) in AUC (0-24) of vilanterol over the observed age range of 41 to 84 years. 
so pa v starosti od 41 do 84 let ugotovili povečanje AUC(0-24) vilanterola za 37 %.
Musculoskeletal and connective tissue disorders 
Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija bolečine v hrbtu zlomi**
Fluticasone furoate/vilanterol 92/22 micrograms increased adjusted mean weighted mean FEV1 over 0-4 hours by 148 ml compared to FF alone (95% CI: 112, 184 mL, p< 0.001). 
Flutikazonfuroat/vilanterol 92/22 mikrogramov je v primerjavi s samim FF povečal korigirani povprečni uteženi FEV1 v obdobju 0-4 ure za 148 ml (95 % IZ:
How to store Relvar Ellipta 
Shranjevanje zdravila Relvar Ellipta
While you're using Relvar Ellipta 
Med uporabo zdravila Relvar Ellipta
Package leaflet: Information for the user Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed 
Navodilo za uporabo Relvar Ellipta 92 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni Relvar Ellipta 184 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/vilanterol
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Relvar Ellipta 92 micrograms/22 micrograms inhalation powder fluticasone furoate/vilanterol 
IME ZDRAVILA IN POT(I) UPORABE Relvar Ellipta 92 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/vilanterol za inhaliranje
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Relvar Ellipta 184 micrograms/22 micrograms inhalation powder fluticasone furoate/vilanterol 
IME ZDRAVILA IN POT(I) UPORABE Relvar Ellipta 184 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/vilanterol za inhaliranje
Very common side effects These may affect more than 1 in 10 people: 
Ti se lahko pojavijo pri več kot 1 od 10 bolnikov:
Following repeat dosing of fluticasone furoate/vilanterol for 7 days, there was no significant increase in systemic exposure to vilanterol (Cmax and AUC) in subjects with mild, moderate, or severe hepatic impairment (Child-Pugh A, B or C). 
(Cmax in AUC) pri preiskovancih z blago, zmerno ali hudo okvaro jeter (Child-Pugh A, B ali C) ni bistveno povečala.
Chronic Obstructive Pulmonary Disease 
Infekcijske in parazitske bolezni pljučnica*
184/22, 85.7 in the FF/VI 92/22 and 42.3 in the VI 22 group. 
in v skupini z VI 22 42,3.
Subjects were then randomized to receive either fluticasone furoate/vilanterol 92/22 micrograms, fluticasone furoate 92 micrograms, vilanterol 22 micrograms, or placebo, and treated for a mean of 1.7 years (SD = 0.9 years). 
Bolnike so nato randomizirali na prejemanje enega od štirih zdravljenj: 92/22 mikrogramov kombinacije flutikazonfuroat/vilanterol, 92 mikrogramov flutikazonfuroata, 22 mikrogramov vilanterola ali na placebo;
NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate /vilanterol 
Relvar Ellipta 184 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/vilanterol
Extrasystoles Palpitations Tachycardia 
Srčne bolezni ekstrasistole palpitacije tahikardija občasni redki redki
Very common Rare 
izpuščajem in urtikarijo redki
NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate /vilanterol 
Relvar Ellipta 92 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/vilanterol
Tell your doctor as soon as possible if you develop any of these symptoms. 
Če se vam pojavi kateri od teh simptomov, morate to čim prej povedati svojemu zdravniku.
There was no evidence for gender, weight or BMI to influence the pharmacokinetics of vilanterol based on a population pharmacokinetic analysis in 856 subjects with asthma (500 females). 
preiskovancev s KOPB (340 žensk) ni pokazala, da bi spol, telesna masa ali ITM vplivali na farmakokinetiko vilanterola.
287% higher and AUC(0-24) comparable for those subjects from an Asian heritage compared with subjects from other racial groups. 
AUC(0-24)) v primerjavi z zdravimi preiskovanci.
The inhaler consists of a light grey body, a yellow mouthpiece cover and a dose counter, packed into a foil laminate tray containing a silica gel desiccant sachet. 
Inhalator sestavljajo svetlo sivo ohišje, rumen pokrovček ustnika in števec odmerkov.
Headache Tremor 
• glavobol,
if you have thyroid gland problems. 
če imate težave s ščitnico;
Do not shake the inhaler. 
Inhalatorja ne smete stresati.
Dysphonia 
Odmerjanje
MARKETING AUTHORISATION NUMBER(S) EU/1/13/886/001 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/13/886/001
MARKETING AUTHORISATION NUMBER(S) EU/1/13/886/006 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/13/886/006
Marketing Authorisation Holder: 
Kaj vsebuje navodilo:
MARKETING AUTHORISATION NUMBER(S) EU/1/13/886/004 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/13/886/004
Upper respiratory tract infection Bronchitis 
okužba zgornjih dihal bronhitis gripa kandidoza ust in žrela pogosti
- For the 92/22mcg dose: each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate). 
- Za odmerek 92/22 mcg: ena inhalacija zagotavlja oddani odmerek (odmerek, ki zapusti ustnik) 92
- For the 184/22 dose: each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate). 
- Za odmerek 184/22 mcg: ena inhalacija zagotavlja oddani odmerek (odmerek, ki zapusti ustnik) 184
At Day 169 fluticasone furoate/vilanterol 92/22 micrograms and vilanterol increased adjusted mean trough FEV1 by 129 mL (95% CI: 91, 167 mL, p<0.001) and 83 mL (95% CI: 46, 121mL, p<0.001) respectively compared to placebo. 
92/22 mikrogramov povečal korigirani povprečni najnižji FEV1 169. dan za 129 ml (95 % IZ: 91, 167 ml, p
The increase in fluticasone furoate systemic exposure in subjects with moderate hepatic impairment (Child-Pugh B; fluticasone furoate/vilanterol 184/22 micrograms) was associated with an average 34% reduction in serum cortisol compared with healthy subjects. 
184/22 mikrogramov) povezano s povprečno 34 % znižanjem kortizola v serumu v primerjavi z zdravimi preiskovanci.
Cough 
KOPB.
The recommended dose to treat COPD is one inhalation (92 micrograms of fluticasone furoate and 22 micrograms of vilanterol) once daily at the same time each day. 
KOPB Priporočeni odmerek za zdravljenje KOPB je ena inhalacija (92 mikrogramov flutikazonfuroata in
Change from Baseline in AM Peak Expiratory Flow Treatment difference 
Splošne težave in spremembe na mestu aplikacije pireksija pogosti
MARKETING AUTHORISATION NUMBER(S) EU/1/13/886/003 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/13/886/003
• stomach pain 
• tesnoba.
Blister (alu/Aclar) 
Pretisni omot (alu/Aclar) 84 kapsul
Oral use 
Za peroralno uporabo
Capsule, hard 
100 mg Kapsula, trda
Pharmaceutical Form 
Jakost Farmacevtska oblika Pot uporabe Stična ovojnina
These member states were not able to reach an agreement. 
Te države članice niso mogle doseči soglasja.
The European Commission issued a decision on 12 March 2009. 
Evropska komisija je odločbo izdala dne 12. marca 2009.
Prof Michal Pirożynski (Poland) 
prof. Michal Pirożynski (Poljska)
Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health 
Člen 29 Direktive 2001/83/ES, kakor je bila spremenjena, o napotitvi na podlagi možnega resnega tveganja za javno zdravje.
Ref. EMEA/CHMP/194784/2009 EMEA/H/A-29/990 
EMEA/CHMP/194677/2009 EMEA/H/A-29/991
London, 17 March 2009 Doc. 
London, 17. marca 2009 Sklic dok.
It can also be used to prevent asthma symptoms caused by exercise or other triggering factors, such as house dust, pollen, cats, dogs and cigarette smoke. 
Uporablja se lahko tudi za preprečevanje simptomov astme, ki jih povzročajo telovadba ali drugi sprožilni dejavniki, kot so hišni prah, cvetni prah, mačke, psi in cigaretni dim.
On 4 March 2008, the Swedish medicines regulatory agency referred the matter to the CHMP. 
Švedska regulatorna agencija za zdravila je 4. marca 2008 zadevo napotila na CHMP.
This makes the airways widen, allowing the air to flow more freely. 
Zaradi tega se dihalne poti razširijo, pretok zraka pa je tako bolj prost.
This means that Sabumalin is similar to a ‘reference medicine' already authorised in the European Union (EU) called Sultanol inhaler. 
To pomeni, da je zdravilo Sanohex podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Sultanol inhalator.
The review was carried out under an ‘Article 29' referral1. 
Pregled se je opravil v okviru napotitvenega postopka v skladu s členom 291.
Questions and answers on the referral for Sabumalin salbutamol, metered dose aerosol inhaler, 100 μg/dose 
Vprašanja in odgovori v zvezi z napotitvijo za zdravilo Sanohex salbutamol, inhalator za merjeni odmerek aerosola, 100 μg/odmerek
Why was Sabumalin reviewed? 
Zakaj je bilo zdravilo Sanohex pregledano?
The European Medicines Agency (EMEA) has completed a referral procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Sabumalin. 
Evropska agencija za zdravila (EMEA) je končala napotitveni postopek, do katerega je prišlo po nesoglasju med državami članicami Evropske unije glede odobritve zdravila Sanohex.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Sabumalin outweigh its risks, and that therefore the marketing authorisation for Sabumalin should be granted in all concerned member states. 
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v odboru CHMP je ta zaključil, da koristi zdravila Sanohex odtehtajo z njim povezana tveganja ter da je zato treba dovoljenje za promet z zdravilom Sanohex odobriti v vseh zadevnih državah članicah.
Concerns were also raised regarding how to store the inhaler and the effect of the orientation of the inhaler on the delivery of the medicine. 
Zadržki so bili izraženi tudi glede načina shranjevanja inhalatorja in učinka usmerjenosti inhalatorja na vnos zdravila.
Sabumalin is used to treat the breathing difficulties caused by asthma and chronic obstructive pulmonary disease (COPD). 
Zdravilo Sanohex se uporablja za zdravljenje težav pri dihanju, ki jih povzroča astma, in kronične obstruktivne pljučne bolezni (KOPB).
Company responses provided on: 30 May 2008, 20 October 2008 Opinion date: 
dr. Gonzalo Calvo Rojas (Španija) Datum začetka postopka napotitve: 19. marec 2008 Datum prejema odgovorov družbe: 30. maj 2008, 20. oktober 2008 Datum izdaje mnenja:
This is a procedure when one Member State (the ‘reference Member State', in this instance Sweden) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other member states (the ‘concerned Member States', in this instance Belgium, Denmark, Estonia, Finland, Germany, Greece, Hungary, Italy, Latvia, Lithuania, the Netherlands, Norway, Poland, Portugal, Slovenia, Spain and the United Kingdom). 
To je postopek, v katerem ena od držav članic („referenčna država članica“, v tem primeru Švedska) ovrednoti zdravilo za odobritev dovoljenja za promet z zdravilom v tej državi in tudi drugih državah članicah („zadevne države članice“, v tem primeru Avstrija, Nemčija, Irska in Španija).
The grounds for the referral were concerns regarding that there was not enough data showing that Sabumalin is equivalent to the reference medicine. 
Razlogi za napotitveni postopek so bili zadržki glede nezadostnih podatkov, ki bi dokazovali, da je zdravilo Sanohex enakovredno referenčnemu zdravilu.
Hexal AG submitted Sabumalin to the Swedish medicines regulatory agency for a decentralised procedure on 5 December 2006. 
Družba Hexal AG je dne 5. decembra 2006 švedski regulatorni agenciji za zdravila predložila vlogo za začetek decentraliziranega postopka za zdravilo Sanohex.