natgillin/translations-raw huggingface dataset:
The main measure of effectiveness was progression-free survival (how long the patients lived before their disease got worse): in patients given Cometriq this was 11.2 months, compared with 4.0 months in those given placebo. 
Glavno merilo učinkovitosti je bilo preživetje brez napredovanja raka (kako dolgo so bolniki živeli pred poslabšanjem bolezni).
How is Cometriq used? 
Kako se zdravilo Cometriq uporablja?
In the EU sibutramine was first authorised in January 1999. 
V EU je bil sibutramin prvič odobren januarja 1999.
Other beneficial effects on patients with regards to other system organ classes have not convincingly been shown. 
Drugi koristni učinki na bolnike, kar zadeva druge organske sisteme, niso bili prepričljivo dokazani.
These non-fatal events are considered serious and life-threatening and may be associated with considerable morbidity. 
Ti dogodki brez smrtnega izida veljajo za resne in smrtno nevarne, poleg tega so lahko povezani s precejšnjo smrtnostjo.
1124 Sofia 
1124 Sofija
In addition, the maintenance of weight loss after cessation of treatment is questionable. 
Poleg tega je vzdrževanje izgubljene telesne mase po prenehanju zdravljenja vprašljivo.
04010 Campoverde di Aprilia Italy 
04010 Campoverde di Aprilia Italija
An Article 31 referral was triggered in March 2002 due to safety concerns based on fatal adverse reactions. 
Napotitveni postopek v skladu s členom 31 je bil sprožen marca 2002 zaradi varnostnih zadržkov na podlagi neželenih reakcij s smrtnim izidom.
Even in this “best case scenario” approximately 1400 patients would need to be treated with sibutramine to prevent one CV event. 
Tudi pri tem „najboljšem scenariju“ bi bilo treba približno 1 400 bolnikov zdraviti s sibutraminom, da bi preprečili en kardiovaskularni dogodek.
00-113 Warsaw 
00-113 Varšava
ANNEX III CONDITIONS FOR LIFTING THE SUSPENSION 
DODATEK III POGOJI ZA PREKLIC ZAČASNEGA UMIKA
Plaza CEIN 5, Nave B-14Noain (Navarra) Spain 
Plaza CEIN 5, Nave B-14Noain (Navarra) Španija
2132 WT, Hoofddorp Netherlands 
2132 WT, Hoofddorp Nizozemska
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SIBUTRAMINECONTAINING MEDICINAL PRODUCTS (SEE ANNEX I) 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, KI VSEBUJEJO SIBUTRAMIN (GLEJTE DODATEK I)
DK-1100 København K Denmark 
DK-1100 København K Danska
Rowex Ltd Bantry Co.Cork Ireland 
Rowex Ltd Bantry Co.Cork Irska
The CHMP considered that the currently approved indication and contraindications already provide substantial restrictions and that additional restrictions would not be practical. 
CHMP je menil, da trenutno odobrena indikacija in kontraindikacije že določajo precejšnje omejitve in da dodatne omejitve ne bi bile praktične.
São Sebastião da Pedreira 1000 Lisboa 
São Sebastião da Pedreira 1000 Lizbona
2031 GA, Haarlem Netherlands 
2031 GA, Haarlem Nizozemska
The CHMP also requested a Scientific Advisory Group (SAG) Diabetes/Endocrinology meeting to be held in January to provide additional expert input. 
CHMP je tudi zaprosil za srečanje znanstvene svetovalne skupine (SAG) za sladkorno bolezen in endokrinologijo v januarju, da bi pridobil dodatno strokovno mnenje.
1074 Budapest Hungary 
1074 Budimpešta Madžarska
Abbott Laboratories Kft. Teve u. 1/a-c 1139 Budapest Hungary 
Abbott Laboratories Kft. Teve u. 1/a-c 1139 Budimpešta Madžarska
2740-264 Porto Salvo Portugal 
2740-264 Porto Salvo Portugalska
02-676 Warsaw 
02-676 Varšava
Eastbourne, East Sussex BN22 9AG United Kingdom 
Eastbourne, East Sussex BN22 9AG Združeno Kraljestvo
94528 RUNGIS CEDEX FRANCE 
94528 RUNGIS CEDEX FRANCIJA
The SCOUT data shows a lower benefit compared to previous trials and to the meta-analysis by Rucker et al. (2007). 
Iz podatkov študije SCOUT so razvidne manjše koristi kot iz podatkov iz predhodnih preskušanj in meta analize, ki so jo izvedli Rucker et al. (2007).
• The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended for sibutramine-containing medicinal products, 
• Odbor je upošteval postopek po členu 107 Direktive 2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo sibutramin.
The Sibutramine Cardiovascular OUTcomes (SCOUT) study was initiated in January 
Študija kardiovaskularnih izidov pri sibutraminu (Sibutramine Cardiovascular OUTcomes = SCOUT) se je začela izvajati januarja 2003.
Edvard Thomsens Vej 14 2300 København S Danmark 
Edvard Thomsens Vej 14 2300 København S Danska
Evropská 846/176a 160 00 Praha 6 
Evropská 846/176a 160 00 Praga 6 Češka
Veluwezoom 22 1327 AH, Almere Netherlands 
Veluwezoom 22 1327 AH, Almere Nizozemska
The CHMP also recommended that temporary measures are needed and therefore recommends to the European Commission that the marketing and use of sibutramine-containing medicinal products be suspended forthwith in all concerned EU Member States awaiting the adoption of the final measures. 
CHMP meni tudi, da so potrebni začasni ukrepi, zato priporoča Evropski komisiji, da do uvedbe končnih ukrepov v vseh zadevnih državah članicah EU nemudoma začasno umakne trženje in uporabo zdravil, ki vsebujejo sibutramin.
83602 Holzkirchen Germany 
83602 Holzkirchen Nemčija
Str. Domniţa Ruxandra nr 12, parter, Sector 2, Bucureşti 
Str. Domniţa Ruxandra nr 12, parter, Sector 2, Bukarešta Romunija
1A Farma A/S Herstedøstervej 27-29 DK-2620 Albertslund Denmark 
1A Farma A/S Herstedøstervej 27-29 DK-2620 Albertslund Danska
For the suspension to be lifted the Marketing Authorisation Holders would need to provide the National Competent Authorities with the following: 
Za preklic začasnega umika dovoljenja morajo imetniki dovoljenja za promet z zdravilom pristojnim nacionalnim organom predložiti:
In addition, it was not possible, based on the SCOUT data and other published or unpublished studies, to identify patient groups that may derive benefit from sibutramine use without an increased cardiovascular risk. 
Poleg tega na podlagi podatkov iz študije SCOUT in drugih objavljenih ali neobjavljenih študij ni bilo mogoče opredeliti skupin bolnikov, ki bi utegnile imeti koristi od uporabe sibutramina brez povečanega tveganja kardiovaskularne bolezni.
The current use of sibutramine is already substantially restricted by the SPC and no further useful or practical restrictions were identified. 
Trenutna uporaba sibutramina je v povzetku glavnih značilnosti zdravila že močno omejena, poleg tega nadaljnje uporabne ali praktične omejitve niso bile opredeljene.
2610-008 AMADORA Portugal 
2610-008 AMADORA Portugalska
• The Committee further considered that a patient population in which sibutramine-containing medicinal products have a clear positive benefit/risk cannot be identified based on the current data, 
• Odbor je nadalje menil, da populacije bolnikov, pri kateri imajo zdravila, ki vsebujejo sibutramin, jasno pozitivno razmerje med koristmi in tveganji, na podlagi trenutnih podatkov ni mogoče opredeliti.
With sibutramine treatment, only 30.4% of the patients were responders (defined as patients who lost at least 5% body weight within 3 months), compared with 19.5% of patients treated with placebo. 
Pri zdravljenju s sibutraminom je bilo le 30,4 % odzivnih bolnikov (tj. bolnikov, ki so izgubili vsaj 5 % telesne mase v treh mesecih), v primerjavi z 19,5 % bolnikov, zdravljenih s placebom.
Abbott Laboratories (Hellas) S.A. 512, Vouliagmenis Avenue GR 17456, Alimos Athens 
Abbott Laboratories (Hellas) S.A. 512, Vouliagmenis Avenue GR 17456, Alimos Atene
Verovskova 57 
Verovškova 57
The CHMP also suggested that the influence of gender within this subgroup (61% females compared with 32-37% in the CV Only group and 36% in the CV + DM group) warrants consideration, as the Cox regression analysis suggests that females have a 40% lower risk of primary outcome than males. 
CHMP je tudi predlagal, da je v tej podskupini ustrezno upoštevati vpliv spola (61 % žensk v primerjavi z 32-37 % moških v skupini „samo kardiovaskularna bolezen“ in 36 % v skupini „kardiovaskularna bolezen + sladkorna bolezen tipa 2“), saj je iz Coxove regresijske analize razvidno, da je pri ženskah tveganje primarnega izida za 40 % manjše kot pri moških.
Following the provisions under Article 107(2) of Directive 2001/83/EC, as amended, the Agency's Committee for Medicinal Products for Human Use (CHMP) adopted an opinion recommending the suspension of the Marketing Authorisations for all sibutramine-containing medicinal products (see Annex 1). 
V skladu z določbami člena 107(2) Direktive 2001/83/ES, kakor je bila spremenjena, je Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji sprejel mnenje, ki priporoča začasni umik dovoljenj za promet z vsemi zdravili, ki vsebujejo sibutramin (glejte Dodatek 1).
Furthermore, given the clear divergence of risks between sibutramine and placebo treated patients early on in therapy, the CHMP did not agree that the data supports a treatment duration of one year. 
Poleg tega se zaradi izrazitih razhajanj med tveganji pri bolnikih, zdravljenih s sibutraminom oz. placebom, v zgodnjem obdobju zdravljenja CHMP ni strinjal, da podatki podpirajo trajanje zdravljenja eno leto.
The Committee considered the data from the SCOUT study, the MAHs responses to the CHMP questions, the report from the SAG for Diabetes and Endocrinology and the discussions within the Committee, 
Odbor je upošteval podatke iz študije SCOUT, odgovore imetnikov dovoljenj za promet z zdravilom na vprašanja CHMP, poročilo skupine SAG za sladkorno bolezen in endokrinologijo ter razprave v Odboru.
A procedure under Article 107 of Directive 2001/83/EC was triggered in November 2009 based on preliminary results from SCOUT that suggested an increased cardiovascular risk with sibutramine treatment compared with placebo. 
Postopek v skladu s členom 107 Direktive 2001/83/ES je bil sprožen novembra 2009 na podlagi uvodnih rezultatov študije SCOUT, iz katerih je bilo v primerjavi s placebom razvidno povečano tveganje kardiovaskularne bolezni pri zdravljenju s sibutraminom.
1800 Vilvoorde 
1800 Vilvoorde Belgija
Alameda da Beloura, Edifício 1, 2º - Escritório 15 2710-693 Sintra Portugal 
Alameda da Beloura, Edifício 1, 2º - Escritório 15 2710-693 Sintra Portugalska
Dolenjska c. 242c SI-1000 Ljubljana Slovenia 
Dolenjska c. 242c SI-1000 Ljubljana Slovenija
Comparing sibutramine-treated responders and placebo-treated non-responders (although this comparison may be influenced by behavioural differences including compliance to diet and exercise and is not a logical or scientific comparison to make) provides the most favourable benefit/risk for sibutramine. 
Primerjava odzivnih bolnikov, zdravljenih s sibutraminom, in neodzivnih bolnikov, ki so prejemali placebo (čeprav na to primerjavo lahko vplivajo vedenjske razlike, vključno s prehranskim režimom in telesno aktivnostjo, poleg tega to ni logična ali znanstvena primerjava), kaže najugodnejše razmerje med koristmi in tveganji za sibutramin.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE SUSPENSION OF THE MARKETING AUTHORISATIONS 
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA ZAČASNI UMIK DOVOLJENJ ZA PROMET Z ZDRAVILOM
25110 Helsingborg Sweden 
25110 Helsingborg Švedska
The CHMP also concluded that the SCOUT study confirms that sibutramine has, on average, only a modest effect on weight reduction in obese patients. 
CHMP je tudi zaključil, da študija SCOUT potrjuje, da ima sibutramin povprečno le skromen učinek na zmanjšanje telesne mase pri debelih bolnikih.
Sibutramine-treated patients in SCOUT had a statistically significantly higher incidence of primary outcome events compared with placebo treatment (hazard ratio HR 1.161, p=0.016), driven by non-fatal MI (HR 1.275, p=0.022) and non-fatal stroke (HR 1.354, 0.026). 
V študiji SCOUT je bila pri bolnikih, zdravljenih s sibutraminom, pogostost dogodkov primarnega izida bistveno večja kot pri bolnikih, ki so prejemali placebo (stopnja tveganja HR 1,161, p = 0,016), na katere sta vplivala miokardni infarkt brez smrtnega izida (HR 1,275, p = 0,022) in srčna kap brez smrtnega izida (HR 1,354, p = 0,026).
821 08 Bratislava Slovak Republic 
821 08 Bratislava Slovaška
In addition, it is impossible to exclude patients with covert cardiovascular disease from receiving sibutramine even with risk minimisation measures in place. 
Poleg tega je nemogoče zagotoviti, da bolniki z neočitno kardiovaskularno boleznijo ne bi prejemali sibutramina, kljub temu, da se izvajajo ukrepi za zmanjšanje tveganja.
Additionally, the CHMP noted the exclusion of 231 high-risk patients with increased HR and/or BP during the Lead-in Period, which is likely to dilute and underestimate the true risk of CV events in the sibutramine arm as such regular and careful BP and HR monitoring is unlikely to be fully implemented in clinical practice. 
Poleg tega je CHMP opazil izključitev 231 bolnikov z visokim tveganjem s povečanim srčnim utripom in/ali krvnim tlakom v obdobju uvajanja, kar je zelo verjetno prispevalo k zmanjšanju in podcenjevanju dejanskega tveganja kardiovaskularnih dogodkov pri kraku s sibutraminom, saj se tako redno in skrbno spremljanje krvnega tlaka in srčnega utripa redko v celoti izvaja v klinični praksi.
The CHMP assessed the proposed risk minimisation measures but noted no changes to the current indicated population and no additional testing for covert cardiovascular conditions besides those already listed in the SPC. 
CHMP je ocenil predlagane ukrepe za zmanjšanje tveganja, vendar ni navedel sprememb populacije, za katero je zdravilo trenutno indicirano, ali dodatnih testiranj neočitnih kardiovaskularnih stanj poleg teh, ki so že navedena v povzetku glavnih značilnosti zdravila.
251 10 Helsingborg Sweden 
251 10 Helsingborg Švedska
No firm conclusion was reached with regards to these reactions and on the basis of the available data on sibutramine, the CHMP therefore considered the benefit-risk balance to be favourable and adopted an Opinion recommending the maintenance of the Marketing Authorisations. 
Na podlagi teh reakcij in razpoložljivih podatkov o sibutraminu ni bilo doseženih trdnih zaključkov, zato je CHMP menil, da je razmerje med koristmi in tveganji ugodno, in sprejel mnenje, v katerem je priporočil ohranitev dovoljenj za promet z zdravilom.
The proposed educational measures (including Direct Healthcare Professional Communication (DHPC) letters, Q&A documents, a call centre and a secure website and patient tracking log books) were not considered likely to decrease the risk for patients or allow the identification of patients with covert CV disease as atherosclerotic complications cannot be diagnosed by BP, HR or weight measurements. 
Predlagane izobraževalne ukrepe (vključno z neposrednimi obvestili zdravstvenim delavcem (DHPC), dokumenti z vprašanji in odgovori, klicnim centrom in varnim spletnim mestom ter dnevniki za bolnike) niso šteli kot verjetne za zmanjšanje tveganja pri bolnikih ali za opredelitev bolnikov z neočitno kardiovaskularno boleznijo, saj ateroskleroznih zapletov ni mogoče diagnosticirati z meritvami krvnega tlaka, srčnega utripa ali telesne mase.
The Kaplan-Meier curve shows an early increased risk of POE and an even earlier increase for non-fatal POE. 
Kaplan-Meierjeva krivulja kaže zgodnje povečano tveganje dogodkov primarnega izida in še bolj zgodnje povečanje dogodkov primarnega izida brez smrtnega izida.
In all trials including SCOUT the average weight loss with sibutramine was 2-4 kg more than with placebo. 
V vseh preskušanjih v okviru študije SCOUT je bila povprečna izguba telesne mase pri zdravljenju s sibutraminom za 2-4 kg večja kot pri skupini s placebom.
The MAHs provided data on improvements in surrogate markers associated with sibutramine treatment but the CHMP noted that despite these effects an increased cardiovascular risk had been observed, and there were no other benefits other than those indirectly related to weight loss. 
Imetniki dovoljenja za promet z zdravilom so predložili podatke o izboljšanju nadomestnih označevalcev, povezanih z zdravljenjem s sibutraminom, vendar je CHMP opozoril, da je bilo kljub tem učinkom opaženo povečano tveganje kardiovaskularne bolezni in da razen koristi, ki so posredno povezane z izgubo telesne mase, ni nobenih drugih koristi.
ANNEX I LIST OF THE INVENTED NAME, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EU/EEA) 
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH IN ISLANDIJI
Consequently the CHMP expressed concern that the increase in rates of POEs in the sibutramine arm compared with placebo was in fact sufficient to be statistically significant. 
Posledično je CHMP izrazil zadržek, da je povečanje pogostosti dogodkov primarnega izida pri kraku s sibutraminom v primerjavi s placebom dejansko dovolj veliko, da je statistično pomembno.
The mean change in weight from lead-in period baseline to treatment period final visit thus shows that patients receiving sibutramine lost 1.9 kg more weight than those taking placebo (3.5 kg vs. 1.6 kg). 
Povprečna sprememba telesne mase od začetka obdobja uvajanja do konca obdobja zdravljenja tako kaže, da so bolniki, ki so prejemali sibutramin, izgubili 1,9 kg več telesne mase kot bolniki, ki so prejemali placebo (3,5 kg oz. 1,6 kg).
The CHMP concluded that the benefit/risk balance of sibutramine-containing medicinal products is affected adversely by the results from the SCOUT study and is considered to be negative. 
CHMP je zaključil, da na razmerje med koristmi in tveganji za zdravila, ki vsebujejo sibutramin, negativno vplivajo rezultati študije SCOUT, zato velja za negativno.
In patients treated according to the approved SPC, i.e. conformers, which accounted for less than 10% of enrolled patients, a numerically slightly increased risk of cardiovascular events was observed when compared to placebo, although the numbers are small and the confidence intervals are wide in this subgroup. 
Pri bolnikih, zdravljenih v skladu z odobrenim povzetkom glavnih značilnosti zdravila, tj. konformnih bolnikih, ki so predstavljali manj kot 10 % vključenih bolnikov, so opazili številčno nekoliko povečano tveganje kardiovaskularnih dogodkov v primerjavi s placebom, čeprav so v tej podskupini številke majhne, intervali zaupanja pa veliki.
• The Committee considered that the risk minimisation measures proposed by the MAHs will not ensure compliance with the SPC or adequately protect public health, 
• Odbor je menil, da ukrepi za zmanjšanje tveganja, ki so jih predlagali imetniki dovoljenja za promet z zdravilom, ne bodo zagotovili skladnosti s povzetkom glavnih značilnosti zdravila ali ustrezno zaščitili javnega zdravja.
S.C. TERAPIA S.A. Str. Fabricii, nr. 124, Cluj-Napoca, Romania 
Str. Fabricii, nr. 124, Cluj-Napoca, Romunija
In conclusion, the CHMP considered that the proposed risk minimisation measures were inadequate to ensure SPC compliance or to adequately minimise the potential cardiovascular and cerebrovascular risks. 
CHMP je naposled menil, da predlagani ukrepi za zmanjšanje tveganja niso ustrezni za zagotovitev skladnosti povzetka glavnih značilnosti zdravila ali ustrezno zmanjšanje morebitnih tveganj kardiovaskularne in cerebrovaskularne bolezni.
Sibutramine significantly increased blood pressure (BP) and heart rate (HR) when compared with placebo (although both reduced diastolic blood pressure and heart rate in patients losing weight) which may have contributed to the observed difference in CV event rates. 
Sibutramin je močno povečal krvni tlak (BP) in srčni utrip (HR) v primerjavi s placebom (čeprav sta se v obeh primerih zmanjšala diastolični krvni tlak in srčni utrip pri bolnikih, ki so izgubljali telesno maso), kar je morda prispevalo k opaženi razliki v pogostosti kardiovaskularnih dogodkov.
After 12 months of treatment no additional mean weight loss was achieved with sibutramine. 
Po 12 mesecih zdravljenja pri skupini, zdravljeni s sibutraminom, ni bilo več opaziti nobene dodatne povprečne izgube telesne mase.
• The Committee considered that the cardiovascular safety concerns are not adequately counterbalanced by the beneficial effects of sibutramine as, on average, the weight loss achieved with the drug is modest, and may not be sustained after cessation of treatment, 
• Odbor je menil, da varnostni zadržki glede kardiovaskularnih dogodkov ne odtehtajo v zadostni meri koristi sibutramina, saj je povprečno izguba telesne mase po zaslugi zdravila zmerna in se po prenehanju zdravljenja ne ohrani.
SI - 1000 Ljubljana Slovenia 
SI - 1000 Ljubljana Slovenija
During the December 2009 meeting, following the MAHs Oral Explanation, the CHMP therefore adopted a List of Outstanding Issues, asking the MAHs to further discuss, based on the SCOUT data, any potential patient population in which a positive benefit/risk balance could be established, the evidence of any favourable effect of sibutramine treatment compared to placebo and further risk minimisation measures. 
Na zasedanju decembra 2009 je CHMP po ustnem pojasnilu imetnikov dovoljenja za promet z zdravilom zato sprejel seznam nerešenih vprašanj, pri čemer je imetnike dovoljenja za promet z zdravilom prosil, naj na podlagi podatkov iz študije SCOUT nadalje proučijo morebitne populacije bolnikov, pri katerih bi bilo mogoče ugotoviti pozitivno razmerje med koristmi in tveganji, dokaz morebitnih ugodnih učinkov zdravljenja s sibutraminom v primerjavi z zdravljenjem s placebom in nadaljnje ukrepe za zmanjšanje tveganja.
Moreover, although sophisticated CV screening tests are available such tests are neither reliable to predict future CV events nor practical for detection of CV disease prior to sibutramine treatment. 
Čeprav so na voljo zapleteni presejalni testi kardiovaskularnih dogodkov, taki testi niso ne zanesljivi za napoved prihodnjih kardiovaskularnih dogodkov ne praktični za odkrivanje kardiovaskularne bolezni pred zdravljenjem s sibutraminom.
Sibutramine is an orally administered serotonin and noradrenaline reuptake inhibitor that is indicated as adjunctive therapy for adult patients within a weight management programme, including weight loss and maintenance of weight loss. 
Sibutramin je zaviralec ponovnega privzema serotonina in noradrenalina za peroralno uporabo, ki je indiciran za adjuvantno zdravljenje odraslih bolnikov v okviru programa uravnavanja telesne mase, vključno z izgubo telesne mase in ohranjanjem zmanjšane telesne mase.
• The Committee concluded that the SCOUT study showed an increased risk of serious cardiovascular events in subjects with cardiovascular disease using sibutramine and because obese subjects are likely to be at risk of cardiovascular disease, the risks identified in the SCOUT study are considered relevant to the clinical use of sibutramine, 
• Odbor je zaključil, da je študija SCOUT pokazala povečano tveganje resnih kardiovaskularnih dogodkov pri osebah s kardiovaskularno boleznijo, ki so prejemali sibutramin, in ker so debele osebe pogosto izpostavljene tveganju kardiovaskularne bolezni, veljajo tveganja, opredeljena v študiji SCOUT, pri klinični uporabi sibutramina za pomembna.
In light of the above findings, the CHMP concluded that the benefit/risk ratio for sibutramine-containing medicinal products is not considered favourable and recommended the suspension of the Marketing Authorisations for the sibutramine-containing medicinal products referred to in Annex I. 
Ob upoštevanju zgornjih ugotovitev je CHMP zaključil, da razmerje med koristmi in tveganji za zdravila, ki vsebujejo sibutramin, ni ugodno, zato je priporočil začasni umik dovoljenj za promet z zdravili, ki vsebujejo sibutramin in so navedena v Dodatku I.
Convincing data to identify a patient population in which sustained and clinically-important efficacy of sibutramine-containing products can be demonstrated, and in which the benefit clearly outweighs its risks. 
prepričljive podatke za opredelitev populacije bolnikov, pri kateri je mogoče dokazati trajno in klinično pomembno učinkovitost zdravil, ki vsebujejo sibutramin, in pri kateri koristi jasno odtehtajo tveganja.