natgillin/translations-raw huggingface dataset:
This includes certain medicines used to: - Lower cholesterol (e.g. gemfibrozil, atorvastatin, simvastatin) - Treat pain (e.g. fentanyl, tramadol) - Treat cancer (e.g. cabazitaxel) - Treat epilepsy (e.g. carbamazepine, clonazepam, phenytoin, primidone, valproic acid) - Treat certain psychiatric disorders such as severe anxiety or schizophrenia (e.g. diazepam, 
To vključuje določena zdravila za: zniževanje holesterola (npr. gemfibrozil, atorvastatin, simvastatin) zdravljenje bolečin (npr. fentanil, tramadol) zdravljenje raka (npr. kabazitaksel) zdravljenje epilepsije (npr. karbamazepin, klonazepam, fenitoin, primidon, valprojska kislina) zdravljenje določenih psihiatričnih motenj, npr. hude anksioznosti ali shizofrenije (npr. diazepam, midazolam, haloperidol) zdravljenje motenj spanja (npr. zolpidem) zdravljenje srčnih bolezni ali za znižanje krvnega tlaka (npr. bisoprolol, digoksin, diltiazem, felodipin, nikardipin, nifedipin, propranolol, verapamil) zdravljenje resnih vnetnih bolezni (npr. deksametazon, prednizolon) zdravljenje okužbe s HIV (npr. indinavir, ritonavir) zdravljenje bakterijskih okužb (npr. klaritromicin, doksiciklin) zdravljenje bolezni ščitnice (npr. levotiroksin) zdravljenje protina (npr. kolhicin) zdravljenje težav z želodcem (npr. omeprazol) preprečevanje srčnih bolezni ali možganske kapi (npr. dabigatran-eteksilat)
The TERRAIN study enrolled 375 chemo- and antiandrogen-therapy naïve patients with metastatic CRPC who were randomised to receive either enzalutamide at a dose of 160 mg once daily (N = 184) or bicalutamide at a dose of 50 mg once daily (N = 191). 
Bolnike so randomizirali ali na prejemanje enzalutamida v odmerku 160 mg enkrat na dan (N = 184) ali bikalutamida v odmerku 50 mg enkrat na dan (N = 191).
The median rPFS was not reached (95% CI: 13.8, not reached) in the enzalutamide-treated group and was 3.9 months (95% CI: 3.7, 5.4) in the placebotreated group (Figure 6). 
Mediani rPFS ni bil dosežen (95 % IZ: 13,8, ni bil dosežen) v skupini, zdravljeni z enzalutamidom.
Very common: asthenia, fatigue 
Splošne težave in spremembe na mestu aplikacije zelo pogosti: astenija, utrujenost
Figure 3: Kaplan-Meier Curves of progression-free survival in the STRIVE study (intent-totreat analysis) 
Slika 3: Kaplan-Meierjevi krivulji preživetja brez napredovanja bolezni v študiji STRIVE (analiza znamenom-zdravljenja)
No dose adjustment is necessary when Xtandi is co-administered with inhibitors of CYP3A4. 
V primeru sočasne uporabe zdravila Xtandi z zaviralci CYP3A4 prilagoditev odmerka ni potrebna.
The median time to PSA progression was 8.3 months for patients treated with enzalutamide and 3.0 months for patients who received placebo [HR = 0.25 (95% CI: 0.20, 0.30), p < 0.0001]. 
Mediani čas do napredovanja PSA je bil med prejemniki enzalutamida 8,3 meseca in med prejemniki placeba 3,0 mesece [ROg = 0,25 (95 % IZ: 0,20, 0,30), p < 0,0001].
Titanium dioxide (E171) Purified water 
Ovojnica kapsule: želatina sorbitol in raztopina sorbitanov glicerol titanov dioksid (E171) prečiščena voda
Xtandi - 40 mg film-coated tablets Yellow round - film-coated tablets, debossed with E 40. 
Xtandi 40 mg filmsko obložene tablete Rumene, filmsko obložene tablete okrogle oblike z vtisnjeno oznako E 40.
Xtandi - 80 mg film-coated tablets Yellow oval - film-coated tablets, debossed with E 80. 
Xtandi 80 mg filmsko obložene tablete Rumene, filmsko obložene tablete ovalne oblike z vtisnjeno oznako E 80.
112 film-coated tablets 
FARMACEVTSKA OBLIKA IN VSEBINA 112 filmsko obloženih tablet
How to store Xtandi 
Shranjevanje zdravila Xtandi
• Thyroid agents (e.g. levothyroxine) 
• zdravila za bolezni ščitnice (npr. levotiroksin)
Package leaflet: Information for the patient Xtandi 40 mg soft capsules enzalutamide 
IME ZDRAVILA Xtandi 40 mg mehke kapsule enzalutamid
- Do not chew, dissolve or open the soft capsules before swallowing. 
Mehkih kapsul pred zaužitjem ne smete žvečiti, raztopiti ali odpreti.
Xtandi 80 mg film-coated tablets are yellow oval film-coated tablets, debossed with E 80 Each carton contains 56 tablets in 4 blister wallets of 14 tablets each. 
Xtandi 80 mg filmsko obložene tablete so rumene filmsko obložene tablete, ovalne oblike z vtisnjeno oznako E 80.
• Anticancer agents (e.g. cabazitaxel) 
• zdravila proti raku (npr. kabazitaksel)
Package leaflet: Information for the patient Xtandi 40 mg film-coated tablets 
PODATKI V BRAILLOVI PISAVI xtandi 40 mg filmsko obložene tablete
Common: gynaecomastia 
Motnje reprodukcije in dojk pogosti: ginekomastija
This improves the ability to produce antibodies. 
Tako se zmožnost tvorbe protiteles izboljša.
With regard to safety, the CHMP considered that overall its safety profile is similar to other vaccines. 
Kar se tiče varnosti, je odbor CHMP menil, da je njegov varnostni profil na splošno podoben varnostnemu profilu drugih cepiv.
Vaccination with Vaxelis should be carried out according to official recommendations. 
Cepljenje s cepivom Vaxelis je treba izvajati v skladu z uradnimi priporočili.
It is used in babies and toddlers aged from six weeks to protect against the following infectious diseases: 
Uporablja se pri dojenčkih in malčkih, starejših od šest tednov, za zaščito pred naslednjimi nalezljivimi boleznimi:
These antibody levels have been previously shown to protect against these diseases. 
Predhodno je bilo dokazano, da te ravni protiteles ščitijo pred temi boleznimi.
What measures are being taken to ensure the safe and effective use of Vaxelis? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe cepiva Vaxelis?
This is a summary of the European public assessment report (EPAR) for Vaxelis. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za cepivo Vaxelis.
The full EPAR and risk management plan summary for Vaxelis 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 cepivo Vaxelis sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vaxelis'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 cepiva Vaxelis večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Vaccines work by ‘teaching' the immune system (the body's natural defences) to defend itself against diseases. 
Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo“, kako naj se brani proti boleznim.
The vaccine is ‘adsorbed' on aluminium compounds. 
Cepivo je „adsorbirano“ na aluminijeve spojine.
• hepatitis B (a viral liver infection); 
• hepatitisom B (virusno okužbo jeter);
It is not intended to provide practical advice on how to use Vaxelis. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
A risk management plan has been developed to ensure that Vaxelis is used as safely as possible. 
Za zagotovitev čim varnejše uporabe cepiva Vaxelis je bil pripravljen načrt obvladovanja tveganj.
It must not be used in children who have an uncontrolled or severe illness affecting the brain or nervous system, such as uncontrolled epilepsy (fits), unless the condition has stabilised with treatment and the benefit of vaccination clearly outweighs the risk. 
Ne sme se uporabljati pri otrocih, ki imajo nenadzorovana ali resna obolenja možganov ali živčnega sistema, kot je nenadzorovana epilepsija (napadi), razen če se je stanje z zdravljenjem ustalilo in so koristi cepljenja veliko večje od tveganj.
Other information about Vaxelis 
Druge informacije o cepivu Vaxelis
Vaxelis has been studied in two main studies involving more than 2,500 infants and toddlers over six weeks of age who were given either two or three doses of the vaccine during their first six months of life. 
Cepivo Vaxelis so proučevali v dveh glavnih študijah, ki sta vključevali več kot 2 500 dojenčkov in malčkov, starejših od šest tednov, ki so v prvih šestih mesecih življenja prejeli bodisi dva bodisi tri odmerke cepiva.
A booster dose should be given at least six months after the last of these initial doses. 
Obnovitveni odmerek je treba dati vsaj šest mesecev po zadnjem odmerku od prvega cepljenja.
• diphtheria (a highly contagious disease that affects the throat and skin, and can cause damage to the heart and other organs); 
• davico (visoko nalezljivo boleznijo, ki prizadene grlo in kožo in lahko poškoduje srce in druge organe);
Vaxelis is given by injection into a muscle, normally in the upper thigh or the shoulder. 
Cepivo Vaxelis se daje z injekcijo v mišico, običajno v zgornji del stegna ali rame.
Vaxelis must not be used in children who have ever had an allergic reaction to Vaxelis or a vaccine containing the same components, including substances used during the manufacture of the vaccine and which may be found at extremely low levels (such as the antibiotics neomycin or streptomycin). 
Cepiva Vaxelis se ne sme uporabljati pri otrocih, ki so v preteklosti imeli alergijsko reakcijo na cepivo Vaxelis ali cepivo, ki vsebuje enake sestavine, vključno s snovmi, ki se uporabljajo med procesom izdelave cepiva in ki so lahko prisotne v zelo majhnih količinah (kot sta antibiotika neomicin ali streptomicin).
The recommended initial vaccination schedule is either two or three doses, given at least one month apart to children aged over six weeks. 
Priporočeni začetni program cepljenja sta dva ali trije odmerki, med katerimi mora biti vsaj mesec razmika, otrokom, starejšim od šestih tednov.
What benefits of Vaxelis have been shown in studies? 
Kakšne koristi je cepivo Vaxelis izkazalo v študijah?
It can only be obtained with a prescription. 
Izdaja zdravila je le na recept.
Vaxelis contains small amounts of materials derived from the viruses and bacteria it protects against. 
Cepivo Vaxelis vsebuje majhno količino snovi, pridobljenih iz virusov in bakterij, pred katerimi ščiti.
• invasive diseases (such as pneumonia and meningitis) caused by H. influenzae type-b bacteria 
• invazivnimi boleznimi (kot sta pljučnica in je meningitis), ki jih povzročajo bakterije H. influenzae tipa b (Hib).
Vaxelis or an appropriate combination of other vaccines can be used for the booster dose. 
Za obnovitveni odmerek se lahko uporabi cepivo Vaxelis ali ustrezna kombinacija drugih cepiv.
Both studies showed that Vaxelis produces satisfactory levels of antibodies to protect against all of these six diseases in between 90 and 100% of children who completed the course of vaccination with Vaxelis. 
Obe študiji sta pokazali, da cepivo Vaxelis sproži nastajanje protiteles v zadostni koncentraciji, da pred vsemi šestimi boleznimi zaščiti od 90 do 100 % otrok, ki so zaključili cepljenje s cepivom Vaxelis.
What are the risks associated with Vaxelis? 
Kakšna tveganja so povezana s cepivom Vaxelis?
In these studies, children also received other vaccines according to local vaccination schedules to protect against other childhood diseases such as rotavirus gastroenteritis, measles, mumps, rubella and varicella. 
V teh študijah so otroci prejeli tudi druga cepiva v skladu z lokalnimi programi cepljenja za zaščito pred drugimi otroškimi boleznimi, kot so rotavirus gastroenteritis, ošpice, mumps, rdečke in norice.
The effects of Vaxelis were compared with those of another vaccine, Infanrix hexa, designed to protect against the same six diseases as Vaxelis. 
Učinke cepiva Vaxelis so primerjali z učinki drugega cepiva, Infanrix hexa, ki ščiti pred istimi šestimi boleznimi kot cepivo Vaxelis.
When a child is given the vaccine, the immune system recognises the materials from the bacteria and viruses as foreign and makes antibodies against them. 
Ko otrok prejme cepivo, imunski sistem prepozna snovi bakterij in virusov kot tujek in proti njim razvije protitelesa.
What is Vaxelis and what is it used for? 
Kaj je cepivo Vaxelis in za kaj se uporablja?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vaxelis, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Vaxelis in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For practical information about using Vaxelis, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi cepiva Vaxelis naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
For the full list of all side effects reported with Vaxelis, see the package leaflet. 
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri cepivu Vaxelis, glejte navodilo za uporabo.
It must not be used in children who have ever had encephalopathy (a brain disease) of unknown cause within seven days of receiving a vaccine containing pertussis components. 
Ne sme se uporabljati pri otrocih, ki so v preteklosti preboleli encefalopatijo (obolenje možganov) neznanega vzroka v sedmih dneh po predhodnem odmerku cepiva proti oslovskemu kašlju.
This means that some of the active substances are fixed onto minute particles of aluminium compounds. 
To pomeni, da je nekaj zdravilne učinkovine pritrjene na majhne delce aluminijevih spojin.
For more information about treatment with Vaxelis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju s cepivom Vaxelis preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
• tetanus (lockjaw, usually caused by infection of a wound); 
• tetanusom (mrtvičnim krčem, ki ga navadno povzroči okužba rane);
The most common side effects with Vaxelis include pain, swelling and redness at the site of injection, irritability, crying, sleepiness, fever, reduced appetite and vomiting. 
Najpogostejši neželeni učinki cepiva Vaxelis vključujejo bolečino, otekanje in rdečico na mestu injiciranja, razdražljivost, jok, zaspanost, povišano telesno temperaturo, zmanjšan tek in bruhanje.
• poliomyelitis (polio, a disease that affects the nerves and can lead to muscle weakness or paralysis); 
• otroško paralizo (boleznijo, ki prizadene živce in lahko povzroči oslabelost mišic ali paralizo);
Why is Vaxelis approved? 
Zakaj je bilo cepivo Vaxelis odobreno?
Vaxelis is available in pre-filled syringes as a suspension for injection. 
Cepivo Vaxelis je na voljo v obliki suspenzije za injiciranje v napolnjenih injekcijskih brizgah.
The immune system will then be able to produce antibodies quickly when the person is naturally exposed to the bacteria or viruses. 
Posledično bo imunski sistem ob naravni izpostavitvi bakterijam ali virusom sposoben hitreje tvoriti protitelesa.
They then received a booster dose shortly after their first birthday. 
Malo pred tretjim rojstnim dnem so prejeli še obnovitveni odmerek.
The Committee considered that Vaxelis has been shown to produce satisfactory antibody levels against diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses and Hib. 
Ugotovil je, da je bilo dokazano, da cepivo Vaxelis ustvari zadostne ravni protiteles proti davici, tetanusu, oslovskemu kašlju, virusu hepatitisa B, poliovirusom in Hib.
Vaxelis is a vaccine containing active substances derived from diphtheria, tetanus, pertussis and Haemophilus influenzae type-b bacteria, the hepatitis B virus, and inactivated polioviruses. 
Vaxelis je cepivo, ki vsebuje zdravilne učinkovine, pridobljene iz bakterij davice, tetanusa, oslovskega kašlja in Haemophilus influenzae tipa b, virusa hepatitisa B in inaktiviranih poliovirusov.
The main measure of effectiveness was the production of antibody levels known to be protective against diphtheria, tetanus, poliomyelitis, hepatitis B and H. influenzae type b infections and expected to protect against pertussis. 
Glavno merilo učinkovitosti je bila tvorba protiteles v koncentraciji, ki znano ščiti pred davico, tetanusom, otroški paralizi, hepatitisom B in okužbam s H. influenzae tipa b, in ki po pričakovanju ščiti pred oslovskim kašljem.
How is Vaxelis used? 
Kako se cepivo Vaxelis uporablja?
How does Vaxelis work? 
Kako cepivo Vaxelis deluje?
Vaxelis is a vaccine. 
Zdravilo Vaxelis je cepivo.
Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed) 
Vaxelis konjugirano (adsorbirano) cepivo proti davici, tetanusu, oslovskemu kašlju (acelularno, komponentno), hepatitisu B (rekombinantno), otroški paralizi (inaktivirano) in bakteriji Haemophilus tipa b
• pertussis (whooping cough); 
• oslovskim kašljem;
The European Commission issued a decision on 14 June 2010. 
Evropska komisija je odločbo izdala dne 14. junija 2010.
It was used in combination with an appropriate diet. 
Uporabljal se je v kombinaciji z ustrezno dieto.
14 June 2010 
14. julij 2010
The review was carried out under an ‘Article 107' procedure1. 
Pregled je bil izveden v skladu s postopkom iz člena 1071.
Prof. Philippe Lechat (France) 
prof. Philippe Lechat (Francija)
Prof. Cristina Sampaio (Portugal) 
prof. Cristina Sampaio (Portugalska)
What are the recommendations for patients and prescribers? 
Kakšna so priporočila za bolnike in zdravnike, ki zdravila predpisujejo?
• Doctors should stop prescribing benfluorex. 
• Zdravniki morajo prenehati predpisovati benfluoreks.
What is benfluorex? 
Kaj je benfluoreks?
This has been known to make patients feel less hungry (appetite suppressant). 
To dokazano zmanjša občutek lakote pri bolnikih (zaviralec apetita).
• Patients who have been treated with these medicines in the past should mention this to their doctor, who will look for the signs and symptoms of heart valve disease. 
• Bolniki, ki so se zdravili s temi zdravili v preteklosti, morajo to omeniti svojemu zdravniku, ki jih bo pregledal za znake in simptome bolezni srčnih zaklopk.
Questions and answers on the withdrawal of medicines containing benfluorex EMA/811097/2009 Rev. 1 
Vprašanja in odgovori v zvezi z umikom zdravil, ki vsebujejo benfluoreks EMA/811097/2009 Rev. 1
In addition, there is risk of valve diseases with the use of benfluorex, which was confirmed in a new study conducted in October 2009. 
Poleg tega pri jemanju benfluoreksa obstaja tveganje bolezni srčnih zaklopk, kar potrjuje nova študija, opravljena oktobra leta 2009.
The European Medicines Agency has completed a review of the safety and effectiveness of benfluorex. 
Evropska agencija za zdravila je zaključila pregled varnosti in učinkovitosti benfluoreksa.
Questions and answers on the withdrawal of medicines containing benfluorex 
Vprašanja in odgovori v zvezi z umikom zdravil, ki vsebujejo benfluoreks
Medicines containing benfluorex were first authorised in 1974. 
Zdravila, ki vsebujejo benfluoreks, so bila prvič odobrena leta 1974.
It also has an effect on the liver by increasing the production of glycogen (the storage form of glucose in the liver). 
Učinkuje tudi na jetra, tako da poveča nastajanje glikogena (oblika shranjevanja glukoze v jetrih).
2 Benfluorex-containing products are also authorised but not marketed in Cyprus and Luxemburg. 
2 Zdravila, ki vsebujejo benfluoreks, so odobrena tudi na Cipru in v Luksemburgu, vendar niso v prometu.
Why was benfluorex reviewed? 
Zakaj je bil benfluoreks pregledan?
• Patients who have any questions should speak to their doctor or pharmacist. 
• Bolniki se lahko z vprašanji obrnejo na svojega zdravnika ali farmacevta.
The review included information provided by the market leader from clinical trials, information published in scientific journals, and ‘spontaneous reports' of side effects from patients to the companies that make the medicines or health authorities. 
Pregled je zajemal tudi podatke iz kliničnih preskušanj, ki jih je predložila vodilna družba na tržišču, podatke, objavljene v znanstvenih revijah, in „spontana poročila“ o neželenih učinkih, ki so jih bolniki sporočili družbam, ki izdelujejo zdravila, ali zdravstvenim organom.
In 2007, a re-assessment of the benefit-risk balance led to the withdrawal of the indication for the use in patients with high blood levels of triglycerides, a type of fat. 
Leta 2007 je ponovna ocena razmerja med koristmi in tveganji povzročila umik indikacije uporaba pri bolnikih z visokimi ravnmi trigliceridov (vrste maščobe) v krvi.
As required by Article 107, the French authority informed the CHMP of its action so that the Committee could prepare an opinion on whether the marketing authorisations for products containing benfluorex should be maintained, changed, suspended or revoked across the EU. 
Skladno z določili člena 107 je francoski pristojni organ obvestil CHMP o svojih ukrepih, da bi Odbor lahko oblikoval mnenje v zvezi s tem, ali naj se dovoljenja za promet z zdravili, ki vsebujejo benfluoreks, v EU ohranijo, spremenijo, začasno umaknejo ali prekličejo.
Shortly after, as a precautionary measure, the Portuguese medicines regulatory authority also decided to recall these medicines from the market. 
Kmalu zatem se je tudi portugalski regulativni organ za zdravila odločil, da kot previdnostni ukrep ta zdravila umakne iz prometa.
Benfluorex works by making the cells more sensitive to insulin, which means that the body makes better use of the insulin it produces and the blood glucose is reduced. 
Benfluoreks deluje tako, da poveča občutljivost celic za insulin, kar pomeni, da telo bolje izkoristi lastni insulin, to pa zniža raven glukoze v krvi.
In November 2009, following several reports of cardiac valvulopathy (thickening of the heart valves) and pulmonary arterial hypertension (high blood pressure in the artery that leads from the heart to the lungs), the French medicines regulatory authority carried out a review of the safety of benfluorex and decided to suspend its marketing authorisation. 
Novembra leta 2009 je francoski regulativni organ za zdravila po več prijavah srčne valvulopatije (odebelitve srčnih zaklopk) in pljučne arterijske hipertenzije (visokega krvnega tlaka v arteriji, ki vodi od srca do pljuč) opravil pregled varnosti benfluoreksa in se odločil začasno umakniti njegovo dovoljenje za promet.
The CHMP has reviewed available information on the safety and efficacy of benfluorex-containing medicines, particularly data on the associated risk of heart valve diseases and pulmonary arterial hypertension. 
CHMP je pregledal razpoložljive podatke o varnosti in učinkovitosti zdravil, ki vsebujejo benfluoreks, zlasti podatke o povezanih tveganjih za bolezni srčnih zaklopk in pljučno arterijsko hipertenzijo.
At the time of this review,they were available as tablets containing 150 mg benfluorex hydrochloride in France and Portugal2 under the following invented names, Mediator, Benfluorex Mylan and Benfluorex Qualimed. 
V času pregleda so bile v Franciji in na Portugalskem2 na voljo tablete, ki vsebujejo 150 mg benfluoreksijevega klorida, z naslednjimi lastniškimi imeni: Mediator, Benfluorex Mylan in Benfluorex Qualimed.
The CHMP noted that the available data show that the effect of benfluorex in the treatment of diabetes is only limited. 
CHMP je ugotovil, da razpoložljivi podatki kažejo, da je učinek benfluoreksa pri zdravljenju sladkorne bolezni majhen.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of benfluorex no longer outweigh its risks, and that all marketing authorisations for medicines containing benfluorex should be revoked throughout the European Union (EU). 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi benfluoreksa ne odtehtajo več z njim povezanih tveganj in da je treba dovoljenja za promet z zdravili, ki vsebujejo benfluoreks, preklicati po vsej Evropski uniji (EU).
Company responses provided on: 
Odgovori družbe poslani dne: