FrancophonIA/ELRC3.0 huggingface dataset:
English: Meloxidyl 20 mg/ml
Croatian: KOLIČINA DJELATNE(IH) TVARI Meloksikam 20 mg/ml
English: Label of 100 ml vial
Croatian: VELIČINA PAKOVANJA 100 ml
English: High density polyethylene bottle with high density polyethylene tamper evidence screw cap.
Croatian: Bočica od polietilena visoke gustoće sa sigurnosnim polietilenskim navojnim zatvaračem.
English: Meloxidyl 0.5 mg/ml oral suspension for cats
Croatian: NAZIV VETERINARSKO - MEDICINSKOG PROIZVODA Meloxidyl 0,5 mg/ml, peroralna suspenzija za mačke
English: Meloxidyl 0.5 mg/ml oral suspension for cats Meloxicam
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Meloxidyl 0,5 mg/ml peroralna suspenzija za mačke Meloksikam.
English: High density polyethylene bottle with high density polyethylene tamper evidence screw cap. Low density polyethylene syringe insert for the polypropylene measuring syringes.
Croatian: Uložak u bočici, od polietilena niske gustoće, za umetanje polipropilenske graduirane brizgalice.
English: Meloxidyl 5 mg/ml solution for injection for dogs and cats
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Meloxidyl 5 mg/ml, injekcijska otopina za pse i mačke.
English: Meloxidyl 20 mg/ml solution for injection for cattle, pigs, horses Meloxicam
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Meloxidyl 20 mg/ml, injekcijska otopina za goveda svinje i konje Meloksikam.
English: Marketing authorisation holder: Ceva Santé Animale 10 avenue de la Ballastière 33500 Libourne France
Croatian: Meloxidyl 5 mg/ml: Ceva Santé Animale 10 avenue de la Ballastière 33500 Libourne France
English: In case of overdose, adverse reactions, as listed in Section “Adverse reactions” are expected to be more severe and more frequent.
Croatian: U slučaju predoziranja popratne reakcije opisane u dijelu “Nuspojave” znatno su izraženije i učestalije te je potrebno primijeniti simptomatsku terapiju.
English: 1 ml contains 5 mg of meloxicam.
Croatian: SASTAV DJELATNIH TVARI 1 ml sadržava: meloksikam 5 mg
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: Pri slučajnom samoinjiciranju pripravka potrebno je odmah potražiti liječnički savjet uz predočenje upute za korištenje veterinarsko-medicinskog proizvoda.
English: Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Croatian: Ublažavanje upale i bolova pri akutnim i kroničnim mišićno - koštanim poremećajima.
English: Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood and apathy have occasionally been reported.
Croatian: Povremeno se mogu javiti nuspojave karakteristične za NSPUL, poput gubitka apetita, povraćanja, proljeva, pojave krvi u izmetu te apatije.
English: Manufacturers responsible for batch release: Ceva Santé Animale
Croatian: Proizvođač odgovoran za puštanje serije u promet:
English: In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: Pri slučajnom gutanju pripravka potrebno je odmah potražiti liječnički savjet uz predočenje upute za korištenje veterinarsko-medicinskog proizvoda.
English: Do not use in horses less than 6 weeks of age.
Croatian: Ne koristiti u ždrebadi mlađoj od 6 tjedana.
English: Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound.
Croatian: Najvećim djelom izlučuje se putem žući dok se u mokraći nalazi samo tragovi osnovnog spoja.
English: Pack size: Cardboard box containing one 10 ml vial.
Croatian: Kartonska kutija sadržava jednu bočicu od 10 ml.
English: Label of 5 ml vial
Croatian: Etiketa bočice od 50 ml
English: Meloxidyl 5 mg/ml solution for injection for dogs, cats Meloxicam
Croatian: NAZIV VETERINARSKO - MEDICINSKOG PROIZVODA Meloxidyl 5 mg/ml injekcijska otopina za pse i mačke Meloksikam.
English: Marketing authorisation holder and manufacturer responsible for batch release: Ceva Santé Animale -10 avenue de la Ballastière - 33500 Libourne - France
Croatian: Meloxidyl 20 mg/ml: Ceva Santé Animale 10 avenue de la Ballastière 33500 Libourne France
English: Content
Croatian: ime
English: Route of administration Packaging
Croatian: Put primjene Primarno pakiranje
English: EU numbers Invented name Strengths Pharmaceutical Forms
Croatian: Doza Farmaceutski oblik
English: 0.75 mg/ml Solution for infusion
Croatian: Veličina pakiranja otopina za infuziju za intravensku primjenu otopina za injekcije za intravensku primjenu
English: Package size
Croatian: Broj (EU) odobrenja
English: Packaging Content (concentration)
Croatian: Pakovanje Sadržaj Veličina pakovanja
English: Invented Name
Croatian: EU broj zmišljeni naziv
English: EMA/CHMP/774318/2018 EMEA/H/C/004682
Croatian: EMA/522792/2018 EMEA/H/C/004682
English: In the latter group, there is a lack of authorised therapies.
Croatian: U drugom slučaju postoji manjak odobrenih terapija.
English: Lung function was measured after 4 weeks and 8 weeks of treatment.
Croatian: Funkcija pluća mjerena je nakon 4 tjedana i nakon 8 tjedana liječenja.
English: It is also used in patients who have inherited the F508del mutation from one parent and also have one of the following mutations in CFTR: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G, or 3849+10kbC→T.
Croatian: Također se primjenjuje u bolesnika koji su naslijedili F508del mutaciju od jednog roditelja i ujedno imaju jednu od sljedećih mutacija gena CFTR: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G, ili 3849+10kbC→T.
English: FEV1 is the maximum amount of air a person can breathe out in one second and is a measure of how well the lungs work.
Croatian: FEV1 je maksimalna količina zraka koju osoba može izdahnuti u jednoj sekundi, a pokazuje koliko dobro funkcioniraju pluća.
English: The doses may also need to be adjusted in patients with reduced liver function.
Croatian: Dozu će možda trebati prilagoditi i u bolesnika sa smanjenom funkcijom jetre.
English: Further information on Symkevi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Symkevi nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The main measure of effectiveness was based on improvement in patients' FEV1.
Croatian: Glavni kriterij učinkovitosti temeljio se na poboljšanju FEV1 u bolesnika.
English: Symkevi (tezacaftor / ivacaftor)
Croatian: Symkevi (tezakaftor/ivakaftor)
English: Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Više informacija o statusu lijeka za rijetku bolest možete pronaći ovdje: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The recommended daily dose is one tablet of Symkevi in the morning and one ivacaftor tablet (150 mg) in the evening, about 12 hours later.
Croatian: Preporučena dnevna doza jest jedna tableta lijeka Symkevi ujutro i jedna tableta ivakaftora (150 mg) navečer, otprilike 12 sati nakon prve tablete.
English: The most common side effects with Symkevi (which may affect more than 1 in 10 people) are headache and nasopharyngitis (inflammation of the nose and throat).
Croatian: Najčešće nuspojave lijeka Symkevi (koje se mogu javiti u više od 1 na 10 osoba) jesu glavobolja i nazofaringitis (upala nosa i grla).
English: What measures are being taken to ensure the safe and effective use of Symkevi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Symkevi?
English: Other information about Symkevi
Croatian: Ostale informacije o lijeku Symkevi
English: Build-up of thick and sticky secretions in the lungs causes inflammation and long-term infection.
Croatian: Nakupljanje debelih i ljepljivih izlučevina u plućima uzrokuje upalu i dugotrajnu infekciju.
English: Each tablet contains 100 mg tezacaftor and 150 mg ivacaftor.
Croatian: Svaka tableta sadrži 100 mg tezakaftora i 150 ml ivakaftora.
English: For more information about using Symkevi, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Symkevi pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Therefore, the European Medicines Agency decided that Symkevi's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Symkevi nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: In the former group, Symkevi could especially be a treatment option for those who cannot take a combination of ivacaftor and lumacaftor (another cystic fibrosis medicine), due to side effects or interactions with other medicines they are taking.
Croatian: U prvom bi slučaju Symkevi mogao biti posebno dobra opcija liječenja za osobe koji ne mogu uzimati kombinaciju ivakaftora i lumakaftora (drugi lijek za cističnu fibrozu) zbog nuspojava ili interakcija s drugim lijekovima koje uzimaju.
English: Cystic fibrosis is an inherited disease that has severe effects on the lungs, the digestive system and other organs.
Croatian: Cistična fibroza nasljedna je bolest koja ima ozbiljne učinke na pluća, probavni sustav i druge organe.
English: After 24 weeks of treatment, patients who took the medicines had an average increase in FEV1 of 3.4 percentage points compared with a reduction of 0.6 percentage points in patients who took placebo.
Croatian: Nakon 24 tjedna liječenja, bolesnici koji su uzimali lijekove imali su prosječno povećanje FEV1 od 3,4 postotna boda u usporedbi s smanjenjem od 0,6 postotnih bodova u bolesnika koji su uzimali placebo.
English: The doses of Symkevi and ivacaftor may need to be adjusted if the patient is also taking a type of medicine called a ‘moderate or strong CYP3A inhibitor', such as certain antibiotics or medicines for fungal infections.
Croatian: Doze lijeka Symkevi i ivakaftora trebaju se prilagoditi ako bolesnik uzima i vrstu lijeka koji je „umjereni ili jak inhibitor CYP3A“, kao što su određeni antibiotici ili lijekovi za gljivične infekcije.
English: Side effects reported with Symkevi are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Symkevi pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: What is Symkevi and what is it used for?
Croatian: Što je Symkevi i za što se primjenjuje?
English: Why is Symkevi authorised in the EU?
Croatian: Zašto je lijek Symkevi odobren u EU-u?
English: As for all medicines, data on the use of Symkevi are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Symkevi kontinuirano se prate.
English: Symkevi is available as tablets.
Croatian: Lijek Symkevi dostupan je u obliku tableta.
English: Symkevi should only be prescribed by a doctor with experience in the treatment of cystic fibrosis, and only in patients confirmed to have the mutations mentioned above.
Croatian: Symkevi treba propisati samo liječnik s iskustvom u liječenju cistične fibroze, i to samo bolesnicima kojima je utvrđena navedena mutacija.
English: Cystic fibrosis is caused by mutations in the CFTR gene.
Croatian: Cističnu fibrozu uzrokuju mutacije gena CFTR.
English: Cystic fibrosis is rare, and Symkevi was designated an ‘orphan medicine' (a medicine used in rare diseases) on 27 February 2017.
Croatian: Cistična fibroza rijetka je bolest, a Symkevi je dobio status „lijeka za rijetku bolest” 27. veljače 2017.
English: These actions make mucus and digestive juices less thick, thereby helping to relieve symptoms of the disease.
Croatian: Te aktivnosti čine sluz i probavne sokove rjeđima i na taj način pomažu u ublažavanju simptoma bolesti.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Symkevi have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Symkevi nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: What are the risks associated with Symkevi?
Croatian: Koji su rizici povezani s lijekom Symkevi?
English: Symkevi should be taken together with another medicine containing 150 mg ivacaftor alone.
Croatian: Lijek Symkevi trebao bi se uzimati zajedno s drugim lijekom koji sadrži 150 mg ivakaftora.
English: An overview of Symkevi and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Symkevi i zašto je odobren u EU-u
English: This gene makes the CFTR protein, which works on the surface of cells to regulate the production of mucus and digestive juices.
Croatian: Taj gen proizvodi bjelančevinu CFTR, koja djeluje na površini stanica kako bi regulirala proizvodnju sluzi i probavnih sokova.
English: Symkevi taken together with ivacaftor was shown to be effective at improving lung function in two main studies of patients with cystic fibrosis aged 12 years and above.
Croatian: Lijek Symkevi se u kombinaciji s ivakaftorom pokazao učinkovitim u poboljšavanju funkcije pluća u dvama glavnim ispitivanjima u kojima su sudjelovali bolesnici sa cističnom fibrozom u dobi od 12 godina i stariji.
English: Patients who took Symkevi and ivacaftor had an average increase in FEV1 of 6.5 percentage points compared with an increase of 4.4 percentage points in patients who took ivacaftor alone and a reduction of 0.3 percentage points in patients who took placebo.
Croatian: Bolesnici koji su uzimali lijek Symkevi zajedno s ivakaftorom imali su prosječno povećanje FEV1 od 6,5 postotnih bodova, u usporedbi s povećanjem od 4,4 postotna boda u bolesnika koji su uzimali samo ivakaftor, kao i u usporedbi sa smanjenjem od 0,3 postotna boda u bolesnika koji su uzimali placebo.
English: One of the active substances in Symkevi, tezacaftor, increases the number of CFTR proteins on the cell surface and the other, ivacaftor, increases the activity of the defective CFTR protein.
Croatian: Jedna od djelatnih tvari lijeka Symkevi, tezakaftor, povećava količinu bjelančevina CTFR na površini stanica, dok druga, ivakaftor, povećava djelovanje nepravilne bjelančevine CTFR.
English: Symkevi is a medicine used to treat cystic fibrosis in patients aged 12 years and above.
Croatian: Symkevi je lijek za liječenje cistične fibroze u bolesnika u dobi od šest godina i starijih.
English: In the gut, blockage of the tubes from the pancreas slows down the digestion of food and causes poor growth.
Croatian: U crijevima začepljenje cijevi iz gušterače dovodi do usporavanja probave hrane i uzrokuje spori rast.
English: The mutations reduce the number of CFTR proteins on the cell surface or affect the way the protein works.
Croatian: Mutacije smanjuju broj bjelančevina CTFR na površini stanica ili utječu na njihovo djelovanje.
English: How does Symkevi work?
Croatian: Kako djeluje Symkevi?
English: How is Symkevi used?
Croatian: Kako se Symkevi koristi?
English: Symkevi is used in patients who have a mutation (change) called F508del in the gene for a protein called ‘cystic fibrosis transmembrane conductance regulator' (CFTR).
Croatian: Symkevi se primjenjuje u bolesnika koji imaju mutaciju (promjenu) nazvanu F508del u genu za bjelančevinu nazvanom „transmembranski regulator provodljivosti za ione klora kod cistične fibroze” (engl. cystic fibrosis transmembrane conductance regulator - CFTR).
English: Symkevi, taken with ivacaftor, was compared with placebo (a dummy treatment).
Croatian: Lijek Symkevi, koji se uzimao zajedno s ivakaftorom, uspoređen je s placebom (prividnim liječenjem).
English: What benefits of Symkevi have been shown in studies?
Croatian: Koje su koristi od lijeka Symkevi utvrđene u ispitivanjima?
English: Symkevi contains the active substances tezacaftor and ivacaftor.
Croatian: Symkevi sadrži djelatne tvari tezakaftor i ivakaftor.
English: Symkevi is used in patients who have inherited the F508del mutation from both parents and therefore have the mutation in both copies of the CFTR gene.
Croatian: Symkevi se primjenjuje u bolesnika koji su naslijedili F508del mutaciju od obaju roditelja i stoga imaju mutaciju obiju kopija gena CFTR.
English: The first study involved 510 patients with cystic fibrosis who have inherited the F508del mutation from both parents.
Croatian: Prvo je istraživanje obuhvaćalo 510 bolesnika s cističnom fibrozom koji su naslijedili mutaciju F508del od obaju roditelja.
English: The second study involved 248 patients with cystic fibrosis who have inherited the F508del mutation from one parent and who also have another CFTR mutation.
Croatian: U drugom je istraživanju sudjelovalo 248 bolesnika sa cističnom fibrozom koji su naslijedili F508del mutaciju od jednog od roditelja i koji također imaju i drugu CFTR mutaciju.
English: For the full list of side effects and restrictions with Symkevi, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja zabilježenih pri primjeni lijeka Symkevi potražite u uputi o lijeku.
English: Symkevi is an effective treatment for patients with cystic fibrosis who have inherited the F508del mutation from both parents or patients who have the F508del mutation from one parent and certain other mutations.
Croatian: Lijekom Symkevi učinkovito se liječe bolesnici sa cističnom fibrozom koji su naslijedili F508del mutaciju od oba roditelja ili bolesnici koji su naslijedili mutaciju F508del, kao i određene druge mutacije od jednog roditelja.
English: Symkevi, taken with ivacaftor, was compared with ivacaftor taken alone and with placebo.
Croatian: Lijek Symkevi koji se uzimao zajedno s ivakaftorom uspoređen je s učinkom liječenja samim ivakaftorom, kao i s placebom.
English: As a result, these secretions become thick and cause blockage.
Croatian: Pri cističnoj fibrozi taj sekret postaje gust i uzrokuje začepljenja.
English: Cystic fibrosis affects the cells that produce mucus and digestive juices.
Croatian: Utječe na stanice koje proizvode sluz i probavne tekućine.
English: Further information on Sutent's current uses can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Dodatne informacije o trenutačnim primjenama lijeka Sutent nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 July 2018
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27. srpnja 2018.
English: What is Sutent?
Croatian: Što je Sutent?
English: The evaluation had finished and the CHMP had given a negative opinion.
Croatian: Procjena je bila završena i CHMP je bio dao negativno mišljenje.
English: Sutent has been authorised since July 2006 and contains the active substance sunitinib.
Croatian: Sutent je odobren od srpnja 2006. i sadrži djelatnu tvar sunitinib.
English: In addition, the medicine has known side effects that affect patients' quality of life.
Croatian: Osim toga, lijek ima poznate nuspojave koje utječu na kvalitetu života bolesnika.
English: The company had requested a re-examination of the negative opinion, but this re-examination had not yet finished when the company withdrew the application.
Croatian: Tvrtka je zatražila preispitivanje negativnog mišljenja, ali to preispitivanje još uvijek nije bilo dovršeno u trenutku kada je tvrtka povukla zahtjev.
English: Sutent is a cancer medicine currently authorised for treating the following cancers:
Croatian: Sutent je lijek protiv raka koji je trenutačno odobren za liječenje sljedećih vrsta raka:
English: The active substance in Sutent, sunitinib, is a protein kinase inhibitor.
Croatian: Djelatna tvar lijeka Sutent, sunitinib, inhibitor je protein-kinaze.
English: What is happening with Sutent for treatment in other uses?
Croatian: Što se događa s lijekom Sutent kada je riječ o liječenju u drugim indikacijama?
English: Patients were treated for around a year and the study looked at how long it took for the cancer to come back (disease-free survival).
Croatian: Bolesnici su liječeni otprilike godinu dana, a ispitivanjem se promatralo koliko je vremena proteklo do ponovne pojave raka (preživljenje bez bolesti).
English: This means that it blocks specific enzymes known as protein kinases that are involved in the growth and spread of cancer cells and the development of new blood vessels supplying them.
Croatian: To znači da inhibira određene enzime poznate pod nazivom protein kinaze koji su uključeni u rast i širenje stanica raka i u razvoj novih krvnih stanica koje ih opskrbljuju.
English: There are no consequences for Sutent in its authorised uses.
Croatian: Nema posljedica na primjenu lijeka Sutent u odobrenim indikacijama.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Sutent.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su u ovom trenutku uključeni u klinička ispitivanja u kojima se koristi lijek Sutent.
English: How does Sutent work?
Croatian: Kako djeluje Sutent?
English: What was Sutent expected to be used for?
Croatian: Za što se Sutent trebao koristiti?
English: When data from patients at highest risk of cancer returning were looked at separately, the benefits of Sutent were still not convincing.
Croatian: Kad su podatci o bolesnicima s najvišim rizikom od ponovne pojave raka bubrega promatrani odvojeno, koristi od lijeka Sutent još uvijek nisu bile uvjerljive.
English: By blocking these enzymes, Sutent can reduce the growth and spread of the cancer and cut off the blood supply that keeps cancer cells growing.
Croatian: Inhibirajući ove enzime Sutent može smanjiti rast i širenje raka te prekinuti dovod krvi koji omogućuje rast stanica raka.
English: On 26 June 2018, Pfizer Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application to extend use of Sutent to the treatment of patients at high risk of kidney cancer returning after surgery.
Croatian: Dana 26. srpnja 2018., Pfizer Limited službeno je obavijestio Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za proširenje indikacija lijeka Sutent na liječenje bolesnika s visokim rizikom od ponovne pojave raka bubrega nakon operacije.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing because the data provided do not allow the CHMP to conclude that the benefit outweighs the risks.
Croatian: U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva tvrtka je navela da zahtjev povlači jer dostavljeni podatci ne omogućuju CHMP-u da zaključi kako koristi od lijeka nadmašuju s njim povezane rizike.
English: The company presented results of a main study comparing Sutent with placebo (a dummy treatment) in 615 patients at high risk of their kidney cancer coming back after surgery.
Croatian: Tvrtka je predstavila rezultate glavne studije u kojoj je Sutent uspoređen s placebom (prividno liječenje) u 615 bolesnika s visokim rizikom od ponovne pojave raka bubrega nakon operacije.
English: • gastrointestinal stromal tumour (a cancer of the stomach and bowel);
Croatian: • gastrointestinalnog stromalnog tumora (rak želuca i crijeva)
English: • metastatic renal cell carcinoma (kidney cancer that has spread to other parts of the body).
Croatian: • metastatskog karcinoma bubrežnih stanica (rak bubrega, koji se proširio na druge dijelove tijela).
English: The CHMP considered that the evidence that Sutent delays the return of the cancer was not convincing.
Croatian: CHMP je smatrao kako dokazi o tome da Sutent odgađa ponovnu pojavu raka nisu uvjerljivi.