natgillin/translations-raw huggingface dataset:
The product information will be updated with strengthened warnings about the risks with Iclusig, and to also provide healthcare professionals with the latest evidence in case they wish to consider reducing the dose of Iclusig in patients with ‘chronic phase' CML who are responding well to treatment, and who might be at particular risk of blood vessel blockage.
Informacije o zdravilu so bile posodobljene z okrepljenimi opozorili glede tveganj pri uporabi zdravila Iclusig in z namenom, da bi zdravstvenim delavcem zagotovili najnovejše dokaze v pomoč pri presoji morebitnega zmanjšanja odmerka zdravila Iclusig pri bolnikih s KML v kronični fazi, ki se dobro odzivajo na zdravljenje in pri katerih je tveganje za zaporo žil morda posebej visoko.
• The benefit-risk balance of Iclusig remains positive in all authorised indications, and the starting dose remains 45 mg per day.
• Razmerje med koristmi in tveganji zdravila Iclusig ostaja pozitivno za vse odobrene indikacije, začetni odmerek pa ostaja 45 mg na dan. Pred začetkom zdravljenja z zdravilom Iclusig je treba oceniti kardiovaskularno stanje bolnika ter ga med samim zdravljenjem redno spremljati.
However, the Committee noted that many patients required reductions in their dose and recommended that the company should study whether starting at lower doses would still be effective but would have fewer side effects.
Kljub temu je odbor izpostavil, da je bilo treba pri mnogih bolnikih zmanjšati odmerek, in priporočil, naj družba prouči, ali bi bila uvedba zdravila z manjšimi odmerki še vedno učinkovita in bi imela manj neželenih učinkov.
This means that there is more evidence to come about the medicine, which the company is required to provide.
To pomeni, da se o njem pričakujejo dodatni dokazi, ki jih mora zagotoviti družba.
The side effects were considered manageable and were acceptable, compared with the limited other treatment options available.
Neželeni učinki so bili v primerjavi z drugimi omejenimi razpoložljivimi možnostmi zdravljenja obvladljivi in sprejemljivi.
The European Commission granted a marketing authorisation valid throughout the European Union for Cometriq on 21 March 2014.
Evropska komisija je dovoljenje za promet z zdravilom Cometriq, veljavno po vsej Evropski uniji, izdala 21. marca 2014.
The recommended dose is 140 mg once a day, taken as one 80-mg and three 20-mg capsules.
Priporočeni odmerek je 140 mg enkrat na dan, kar vključuje eno 80-miligramsko in tri 20-miligramske kapsule.
By blocking the activity of these receptors in cancer cells, the medicine reduces the growth and spread of the cancer.
Z zaviranjem dejavnosti teh receptorjev v rakavih celicah zdravilo zmanjša rast in širjenje raka.
Cometriq is available as capsules (20 and 80 mg).
Zdravilo Cometriq je na voljo v obliki kapsul (20 in 80 mg).
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Cometriq's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Cometriq večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
This is a summary of the European public assessment report (EPAR) for Cometriq.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Cometriq.
What measures are being taken to ensure the safe and effective use of Cometriq?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Cometriq?
Patients should not eat for at least two hours before and one hour after their dose of Cometriq.
Bolniki vsaj dve uri pred odmerjanjem zdravila in eno uro po njem ne smejo uživati hrane.
Treatment is continued until the patient no longer benefits from it or side effects become unacceptable.
Zdravljenje traja, dokler bolnik od njega nima več kliničnih koristi ali dokler neželeni učinki ne postanejo nesprejemljivi.
The summary of the opinion of the Committee for Orphan Medicinal Products for Cometriq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Cometriq je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
A risk management plan has been developed to ensure that Cometriq is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Cometriq je bil pripravljen načrt obvladovanja tveganj.
Since Cometriq has been granted a conditional approval, the company that markets Cometriq will provide information from a study comparing the safety and effectiveness of different doses of Cometriq, and its benefit in patients lacking the RET gene mutation or whose cancer has changes in another family of genes called RAS.
Ker je zdravilo Cometriq pridobilo pogojno dovoljenje za promet, bo družba, ki ga trži, zagotovila informacije iz študije, ki bo primerjala varnost in učinkovitost različnih odmerkov zdravila Cometriq, ter informacije o njegovi koristi pri bolnikih brez mutacije gena RET ali s spremembami druge družine genov, imenovanih RAS.
Because the number of patients with medullary thyroid cancer is low, the disease is considered ‘rare', and Cometriq was designated an ‘orphan medicine' (a medicine used in rare diseases) on 6 February
Ker je bolnikov z medularnim rakom ščitnice malo, velja ta bolezen za redko, zato je bilo zdravilo Cometriq 6. februarja 2009 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
It is used to treat adults with medullary thyroid cancer, a type of cancer originating in the cells in the thyroid gland that produce the hormone calcitonin.
Uporablja se za zdravljenje medularnega raka ščitnice, vrste raka, ki izvira iz celic v ščitnici, ki proizvajajo hormon kalcitonin.
Cometriq should be used with care in patients taking certain other medicines that affect the way it is broken down in the body.
Zdravilo Cometriq je treba uporabljati previdno pri bolnikih, ki jemljejo nekatera druga zdravila, ki vplivajo na način njegove razgradnje v telesu.
Other information about Cometriq
Druge informacije o zdravilu Cometriq
These enzymes can be found in certain receptors (such as VEGF, MET and RET receptors) in cancer cells, where they activate several processes including cell division and the growth of new blood vessels to supply the cancer.
Ti encimi so prisotni v nekaterih receptorjih (kot so receptorji VEGF, MET in RET) v rakavih celicah, v katerih spodbujajo številne procese, vključno z delitvijo celic in rastjo novih žil, ki oskrbujejo raka.
For the full list of all side effects and restrictions with Cometriq, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Cometriq glejte navodilo za uporabo.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cometriq, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Cometriq in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For more information about treatment with Cometriq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Cometriq preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The benefits of Cometriq may be smaller for patients whose cancer does not have a mutation in a gene called the ‘re-arranged during transfection' (RET) gene, and this should be taken into account when deciding whether to start treatment.
Koristi zdravila so lahko manjše pri bolnikih, ki nimajo mutacije gena, imenovanega gen RET (rearranged during transfection - prerazporejen med transfekcijo), kar je treba upoštevati pri odločanju o uvedbi zdravljenja.
Cometriq can only be obtained with a prescription and treatment should only be started by a doctor who has experience in using cancer medicines.
Izdaja zdravila Cometriq je le na recept, zdravljenje z njim pa sme uvesti samo zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
What is Cometriq and what is it used for?
Kaj je zdravilo Cometriq in za kaj se uporablja?
The full EPAR and risk management plan summary for Cometriq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Cometriq sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cometriq has been shown to be effective in one main study involving 330 adults with medullary thyroid cancer that could not be treated with surgery and was extensive or had spread to other parts of the body.
Učinkovitost zdravila Cometriq so dokazali v eni glavni študiji, v katero je bilo vključenih 330 odraslih bolnikov z medularnim rakom ščitnice, ki ga ni bilo mogoče zdraviti s kirurškim posegom in je bil obsežen ali se je razširil na druge dele telesa.
Cometriq had shown a benefit in patients with advanced medullary thyroid cancer unsuitable for surgery, who have few other treatment options.
Zdravilo Cometriq je pokazalo koristi pri bolnikih z napredovalim medularnim rakom ščitnice, neprimernih za kirurški poseg, ki imajo na voljo malo drugih možnosti zdravljenja.
Why is Cometriq approved?
Zakaj je bilo zdravilo Cometriq odobreno?
What benefits of Cometriq have been shown in studies?
Kakšne koristi je zdravilo Cometriq izkazalo v študijah?
Cometriq is used when the cancer cannot be removed by surgery and has progressed or spread to other parts of the body.
Zdravilo se uporablja, kadar raka ni mogoče odstraniti s kirurškim posegom in je napredoval ali se razširil na druge dele telesa.
What are the risks associated with Cometriq?
Kakšna tveganja so povezana z zdravilom Cometriq?
It is not intended to provide practical advice on how to use Cometriq.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The active substance in Cometriq, cabozantinib, is a tyrosine kinase inhibitor.
Zdravilna učinkovina v zdravilu Cometriq, kabozantinib, je zaviralec tirozin-kinaze.
Cometriq was given once a day in an initial dose of 140 mg (reduced if necessary due to side effects) and compared with placebo (a dummy treatment).
Zdravilo se je dajalo enkrat na dan, pri čemer je bil začetni odmerek 140 mg (ki se je zaradi neželenih učinkov po potrebi zmanjšal), in se je primerjalo s placebom (zdravilom brez zdravilne učinkovine).
For practical information about using Cometriq, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Cometriq naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The most common side effects with Cometriq (which may affect more than 2 in 10 people) are diarrhoea, palmar-plantar erythrodysaesthesia syndrome (hand-foot syndrome, which involves rash and numbness on the palms and soles), loss of weight, loss of appetite, nausea (feeling sick), tiredness, taste disturbances, changes in hair colour, hypertension (high blood pressure), inflammation of the mucosa (moist tissue that lines certain body cavities) including stomatitis (inflammation of the lining of the mouth), constipation, vomiting, weakness, and changes in the sound of the voice.
Najpogostejši neželeni učinki zdravila Cometriq (ki lahko prizadenejo več kot 2 osebi od 10) so driska, sindrom palmarno-plantarne eritrodisestezije (sindrom dlani in stopal, ki vključuje izpuščaj in otrplost v dlaneh in stopalih), izguba telesne mase, izguba teka, navzeja (slabost), utrujenost, motnje okušanja, spremembe barve las, hipertenzija (visok krvni tlak), vnetje sluznice (vlažnega tkiva, s katerim so obložene nekatere telesne votline), vključno s stomatitisom (vnetjem ustne sluznice), zaprtost, bruhanje, šibkost in spremembe glasu.
The most common abnormal results in laboratory blood tests were increased liver enzymes such as aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP), low white cell counts (lymphopenia or neutropenia), thrombocytopenia (low blood-platelet counts), hypocalcaemia (low blood calcium levels), hypophosphataemia (low blood levels of phosphates), hypomagnesaemia (low blood magnesium levels), hypokalaemia (low blood potassium levels) and hyperbilirubinaemia (increased amounts of bilirubin, a breakdown product of red blood cells).
Najpogostejši nenormalni izvidi laboratorijskih krvnih preiskav so povišana raven jetrnih encimov, kot so aspartat-aminotransferaza (AST), alanin-aminotransferaza (ALT) in alkalna fosfataza (ALP), nizko število belih krvničk (limfopenija ali nevtropenija), trombocitopenija (nizko število trombocitov), hipokalciemija (nizka raven kalcija v krvi), hipofosfatemija (nizka raven fosfatov), hipomagneziemija (nizka raven magnezija v krvi), hipokaliemija (nizka raven kalija v krvi) in hiperbilirubinemija (povišana raven bilirubina, ki se tvori ob razgradnji rdečih krvnih celic).
What information is still awaited for Cometriq?
Katere informacije o zdravilu Cometriq še pričakujemo?
Cometriq is a cancer medicine that contains the active substance cabozantinib.
Cometriq je zdravilo za zdravljenje raka, ki vsebuje zdravilno učinkovino kabozantinib.
Cometriq has been given ‘conditional approval'.
Zdravilo Cometriq je pridobilo pogojno dovoljenje za promet.
The most common serious side effects are pneumonia, inflammation of the mucosa, hypocalcaemia (low calcium levels in the blood), dysphagia (difficulty swallowing), dehydration, pulmonary embolism (blood clots in the vessels supplying the lungs), and hypertension.
Najpogostejši resni neželeni učinki so pljučnica, vnetje sluznice, hipokalciemija (nizka raven kalcija v krvi), disfagija (težave pri požiranju), dehidracija, pljučna embolija (krvni strdki v žilah, ki oskrbujejo pljuča) in hipertenzija.
The dose may need to be reduced or stopped temporarily
Zaradi neželenih učinkov bo morda treba zmanjšati odmerek ali začasno prekiniti odmerjanje, predvsem v prvih osmih tednih zdravljenja.
How does Cometriq work?
Kako zdravilo Cometriq deluje?
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
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