natgillin/translations-raw huggingface dataset:
The CHMP concluded that the modest improvement in FEV1 seen with Colobreathe was sufficient evidence of the medicine’s effectiveness, given that larger improvements would not be expected in patients whose condition was already stabilised on tobramycin nebuliser.
Odbor CHMP je zaključil, da je bilo zmerno izboljšanje FEV1, ki so ga opazili pri zdravilu Colobreathe, zadosten dokaz učinkovitosti zdravila, pri čemer je treba upoštevati, da večjih izboljšanj pri bolnikih, pri katerih je bilo stanje že stabilizirano z nebulatorjem s tobramicinom, ni pričakovati.
The CHMP concluded that the removal of thiomersal from vaccines did not reduce their effectiveness in protecting against hepatitis B virus infection, but reduced their risks.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da učinkovitost zaščite proti virusu hepatitisa B zaradi odstranitve tiomersala iz cepiva ni manjša, se je pa zmanjšala nevarnost cepiva.
The CHMP concluded that there is clear evidence of the benefit of Gilenya in relapsing-remitting MS and noted that it had the benefit of being taken by mouth.
CHMP je zaključil, da je bila učinkovitost zdravila Gilenya pri recidivno-remitentni multipli sklerozi jasno dokazana, in menil, da je prednost zdravila njegovo peroralno jemanje.
The CHMP concluded that treatment with Xalkori has a beneficial effect on the length of time the patients with ALK-positive NSCLC lived without the disease getting worse, irrespective of whether they were previously treated.
Odbor CHMP je menil, da zdravljenje z zdravilom Xalkori koristno vpliva na čas preživetja pri bolnikih z ALK-pozitivnim nedrobnoceličnim pljučnim rakom brez poslabšanja bolezni, ne glede na to, ali so bili predhodno zdravljeni ali ne.
The CHMP concluded that Vectibix’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Vectibix večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP concluded that Xagrid had shown its effectiveness in lowering platelet counts in patients with essential thrombocythaemia.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da je bilo zdravilo Xagrid učinkovito pri zmanjševanju števila krvnih ploščic pri bolnikih z esencialno trombocitemijo.
The CHMP concluded that Yondelis’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Yondelis večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP concluded that Zyclara 3.75% cream had been shown to be effective at clearing actinic keratosis from the skin and that its use did not raise significant safety concerns.
CHMP je zaključil, da se je krema Zyclara z jakostjo 3,75 % izkazala za učinkovito pri odstranjevanju aktiničnih keratoz s kože in da njena uporaba ni sprožila večjih pomislekov glede varnosti.
The CHMP concluded that, in accordance with EU requirements, Abseamed has been shown to have a comparable quality, safety and efficacy profile to Eprex/Erypo.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Abseamed primerljivo kakovost, varnost in učinkovitost kot zdravilo Eprex/Erypo.
The CHMP concluded that, in accordance with EU requirements, Binocrit has been shown to have a comparable quality, safety and efficacy profile to Eprex/Erypo.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Binocrit primerljivo kakovost, varnost in učinkovitost kot zdravilo Eprex/Erypo.
The CHMP concluded that, in accordance with EU requirements, Clopidogrel Teva Generics B.V. has been shown to have comparable quality and to be bioequivalent to Plavix.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Clopidogrel Teva Generics B.V. primerljivo raven kakovosti kot zdravilo Plavix ter da mu je biološko enakovredno.
The CHMP concluded that, in accordance with EU requirements, Clopidogrel Teva Pharma B.V. has been shown to have comparable quality and to be bioequivalent to Plavix.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Clopidogrel Teva Pharma B.V. primerljivo raven kakovosti kot zdravilo Plavix ter da mu je biološko enakovredno.
The CHMP concluded that, in accordance with EU requirements, Clopidogrel Teva Pharma has been shown to have comparable quality and to be bioequivalent to Plavix.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Clopidogrel Teva Pharma primerljivo raven kakovosti kot zdravilo Plavix ter da mu je biološko enakovredno.
The CHMP concluded that, in accordance with EU requirements, Epoetin Alfa Hexal has been shown to have a comparable quality, safety and efficacy profile to Eprex/Erypo.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Epoetin Alfa Hexal primerljivo kakovost, varnost in učinkovitost kot zdravilo Eprex/Erypo.
The CHMP concluded that, in accordance with EU requirements, Lamivudine Teva Pharma B.V. has been shown to have comparable quality and to be bioequivalent to Epivir.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Lamivudine Teva Pharma B.V. primerljivo raven kakovosti kot zdravilo Epivir ter da mu je biološko enakovredno.
The CHMP concluded that, in accordance with EU requirements, Olazax has been shown to have comparable quality and to be bioequivalent to Zyprexa.
CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Olazax primerljivo raven kakovosti kot zdravilo Zyprexa ter da mu je biološko enakovredno.
The CHMP concluded that, in accordance with EU requirements, Oprymea has been shown to have comparable quality and to be bioequivalent to Sifrol.
CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Oprymea primerljivo raven kakovosti kot zdravilo Sifrol ter da mu je biološko enakovredno.
The CHMP concluded that, in accordance with EU requirements, Pioglitazone Accord has been shown to have comparable quality and to be bioequivalent to Actos.
CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Pioglitazone Accord primerljivo raven kakovosti kot zdravilo Actos ter da mu je biološko enakovredno.
The CHMP concluded that, in accordance with EU requirements, Pioglitazone Actavis has been shown to have comparable quality and to be bioequivalent to Actos.
CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Pioglitazone Actavis Group primerljivo raven kakovosti kot zdravilo Actos ter da mu je biološko enakovredno.
The CHMP concluded that, in accordance with EU requirements, Silapo has been shown to have a comparable quality, safety and efficacy profile to Eprex/Erypo.
CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Silapo primerljivo kakovost, varnost in učinkovitost kot zdravilo Eprex/Erypo.
The CHMP concluded that, in both previously untreated patients and patients who had already been treated, adding Olysio to treatment with peginterferon alfa and ribavirin considerably increased the number of patients showing no sign of infection.
Ugotovil je, da je dodajanje zdravila Olysio k zdravljenju s peginterferonom alfa in ribavirinom pri predhodno nezdravljenih bolnikih in bolnikih, ki so se pred tem že zdravili, znatno povečalo število bolnikov, ki niso imeli nobenih znakov okužbe.
The CHMP concluded that, provided that very strict measures are put in place to avoid exposure of unborn children to thalidomide, Thalidomide Celgene’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so pod pogojem, da se upoštevajo strogi ukrepi glede preprečevanja izpostavitve nerojenih otrok talidomidu, koristi zdravila Thalidomide Celgene večje od z njim povezanih tveganj in da se za zdravilo lahko izda dovoljenje za promet.
The CHMP considered Ebymect to be effective at controlling blood glucose levels; it also leads to weight loss, which is considered beneficial in patients with diabetes.
CHMP je menil, da je zdravilo Ebymect učinkovito pri uravnavanju ravni glukoze v krvi; poleg tega povzroči zmanjšanje telesne mase, kar je koristno za bolnike s sladkorno boleznijo.
The CHMP considered that adding Sovaldi to standard treatment is of benefit to patients.
Odbor CHMP je menil, da je dodajanje zdravila Sovaldi standardnemu zdravljenju koristno za bolnike.
The CHMP considered that Adempas led to significant improvements in exercise capacity in patients with CTEPH or PAH.
Odbor CHMP je menil, da je zdravilo Adempas pomembno izboljšalo telesno zmogljivost bolnikov s CTEPH ali PAH.
The CHMP considered that available study results, although not final, consistently showed the benefits of Keytruda in patients with advanced melanoma.
Odbor CHMP je menil, da so razpoložljivi rezultati študij (pa čeprav niso končni) dosledno pokazali koristi zdravila Keytruda pri bolnikih z napredovalim melanomom.
The CHMP considered that Benlysta, used as an add-on treatment, reduced disease activity in SLE without serious risk to the patient.
Odbor CHMP je menil, da zdravilo Benlysta, kadar se uporablja kot dodatno zdravilo, zmanjšuje bolezensko aktivnost pri sistemskem eritematoznem lupusu brez resnega tveganja za bolnike.
The CHMP considered that Bexsero had been shown to produce a robust immune response to N. meningitidis group B and the risks were acceptable.
CHMP je menil, da se je za cepivo Bexsero izkazalo, da spodbuja izrazit imunski odziv na bakterijo N. meningitidis skupine B in da so tveganja sprejemljiva.
The CHMP considered that Defitelio had been shown to improve survival in patients with severe VOD.
Upošteval je, da so pri zdravilu Defitelio dokazali izboljšano preživetje pri bolnikih s hudo VOB.
The CHMP considered that Esmya was shown to be effective in reducing bleeding and anaemia as well as the size of the fibroids in women who were to undergo surgery for their fibroids.
Menil je, da se je zdravilo Esmya izkazalo kot učinkovito pri zmanjšanju krvavitev in anemije ter velikosti leiomiomov pri ženskah, pri katerih je bilo treba opraviti kirurški poseg za njihovo odstranitev.
The CHMP considered that Eurartesim had been shown to be effective in treating uncomplicated
CHMP je menil, da je zdravilo Eurartesim dokazano učinkovito pri zdravljenju nezapletene malarije
The CHMP considered that Fampyra was likely to benefit approximately one third of patients with MS who have a walking disability, and that patients benefiting from the treatment can be identified at an early stage allowing treatment to be stopped in other patients.
CHMP je menil, da zdravilo Fampyra verjetno koristi približno eni tretjini bolnikov z MS z nezmožnostjo hoje ter da je že v zgodnji fazi zdravljenja mogoče ugotoviti, katerim bolnikom zdravilo koristi, kar omogoča, da se pri drugih bolnikih zdravljenje prekine.
The CHMP considered that Imbruvica was shown to be effective at delaying progression of chronic lymphocytic leukaemia, both in patients previously untreated and in those who received previous treatment.
Menil je, da se je zdravilo Imbruvica izkazalo kot učinkovito pri upočasnitvi napredovanja kronične limfocitne levkemije pri predhodno zdravljenih in tudi predhodno nezdravljenih bolnikih.
The CHMP considered that Nimenrix had been shown to be at least as effective as comparable vaccines at stimulating an immune response to the four groups of the N. meningitidis bacterium in people of different age groups.
CHMP je menil, da je bilo za cepivo Nimenrix dokazano, da je pri spodbujanju imunskega odziva proti štirim vrstam polisaharidov bakterije N. meningitidis pri ljudeh različnih starostnih skupin najmanj tako učinkovito kot primerjalna cepiva.
The CHMP considered that Opdivo has been convincingly shown to benefit patients with certain advanced cancers (melanoma, NSCLC or renal cell carcinoma) by either increasing patients’ survival or the time they could live without their disease getting worse.
Menil je, da so pri zdravilu Opdivo prepričljivo dokazane koristi za bolnike z nekaterimi napredovalimi oblikami raka (melanomom, nedrobnoceličnim pljučnim rakom ali karcinomom ledvičnih celic), saj je podaljšal čas preživetja bolnikov ali čas, ko so lahko živeli brez poslabšanja bolezni.
The CHMP considered that Plegridy given every two weeks has been shown to produce about a 30% reduction in the number of relapses in patients with relapsing-remitting MS compared with placebo, which is comparable to the effect of other MS medicines containing non-pegylated interferon beta, and is considered clinically relevant.
Odbor CHMP je upošteval dokaze, da zdravilo Plegridy, ki se daje vsaka dva tedna, zmanjša število relapsov pri bolnikih z recidivno-remitentno MS za približno 30 % v primerjavi s placebom, kar je primerljivo z učinkom drugih zdravil proti MS, ki vsebujejo nepegiliran interferon beta, in je klinično pomembno.
The CHMP considered that Revestive was beneficial for adults with short bowel syndrome as it significantly reduced the amount of parenteral nutrition needed, an effect which was maintained after a year of treatment.
CHMP je menil, da je zdravilo Revestive koristno za bolnike s sindromom kratkega črevesa, saj znatno zmanjšuje potrebno količino parenteralne prehrane in ta učinek vzdržuje po enem letu zdravljenja.
The CHMP considered that Reyataz’s effectiveness had been shown in patients aged at least 3 months and weighing at least 5 kg.
Odbor za zdravila za uporabo v humani medicini (CHMP) je menil, da je bila učinkovitost zdravila Reyataz dokazana pri bolnikih, starih najmanj tri mesece in s telesno maso najmanj pet kg.
The CHMP considered that the ability of Jevtana to prolong overall survival in hormone refractory metastatic prostate cancer patients was clinically important.
Odbor za zdravila za uporabo v humani medicini (CHMP) je menil, da je zmožnost zdravila Jevtana, da podaljša skupno preživetje bolnikov s hormonsko neodzivnim metastatskim rakom prostate, klinično pomembna.
The CHMP considered that the anticancer effects of Xtandi had been clearly demonstrated and that its benefit in prolonging life is important for patients.
Prav tako meni, da so bili učinki zdravila Xtandi proti raku jasno dokazani in da je njegova korist glede podaljševanja življenja pomembna za bolnike.
The CHMP considered that the benefit of Gazyvaro in prolonging the survival of CLL and FL patients before their disease worsened was clearly demonstrated.
Odbor CHMP je menil, da je bila korist zdravila Gazyvaro pri podaljšanju časa preživetja bolnikov s KLL in FL do poslabšanja bolezni jasno dokazana.
The CHMP considered that the benefit of Lonsurf in prolonging survival in patients with metastatic colorectal cancer who have received previous treatment was clinically relevant.
Odbor CHMP je zaključil, da je korist zdravila Lonsurf pri podaljšanju preživetja bolnikov z metastatskim kolorektalnim rakom, ki so se predhodno že zdravili, klinično pomembna.
The CHMP considered that the benefit of Lynparza in prolonging survival of cancer patients with a BRCA mutation before their disease got worse was clinically relevant.
CHMP je ocenil, da je bil učinek zdravila Lynparza na podaljšanje preživetja onkoloških bolnic z mutacijo gena BRCA, preden se jim je bolezen poslabšala, klinično pomemben.
The CHMP considered that the benefits of the medicine outweigh its risk and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Pradaxa večje od z njim povezanih tveganj, in priporočil da se zanj izda dovoljenje za promet.
The CHMP considered that the measures put in place are adequate to manage these risks.
Odbor CHMP je menil, da so uvedeni ukrepi ustrezni za obvladovanje teh tveganj.
The CHMP considered that the medicine’s effect in reducing LDL cholesterol levels was a benefit for patients with homozygous familial hypercholesterolaemia, who have an unmet medical need.
Menil je, da je učinek zdravila pri zniževanju ravni LDL-holesterola koristen za bolnike s homozigotno družinsko hiperholesterolemijo in z neizpolnjeno potrebo po zdravilu.
The CHMP considered that the safety profile of Senshio, which was studied for up to 15 months, was in line with medicines working in a similar way (SERMs).
CHMP je menil, da je varnostni profil zdravila Senshio, ki so ga preučevali do 15 mesecev, skladen z zdravili, ki delujejo na podoben način (selektivni modulatorji estrogenskih receptorjev).
The CHMP considered that the use of Ketoconazole HRA to treat Cushing’s syndrome was well established in medical practice and documented in the scientific literature.
CHMP je menil, da je uporaba zdravila Ketokonazol HRA za zdravljenje Cushingovega sindroma ustaljena v klinični praksi in dokumentirana v znanstveni literaturi.
The CHMP considered that treatment with Harvoni, with or without ribavirin, is of high benefit to many patients with hepatitis C virus, including those who have had a liver transplant and/or who have compensated cirrhosis.
Menil je, da ima zdravljenje z zdravilom Harvoni, ki se uporablja skupaj z ribavirinom ali brez njega, velike koristi za številne bolnike, okužene z virusom hepatitisa C, vključno s tistimi s presajenimi jetri in/ali kompenzirano cirozo.
The CHMP considered that treatment with Sevelamer carbonate Zentiva has a beneficial effect in lowering blood phosphate levels without major safety concerns.
CHMP je menil, da zdravljenje z zdravilom Sevelamer carbonate Zentiva ugodno vpliva na znižanje ravni fosfata v krvi, pri čemer ni večjih pomislekov glede varnosti.
The CHMP considered that Zerbaxa had been shown to be effective at curing infections in the patients studied, but acknowledged that only a limited number of patients with complicated urinary tract infections had been included.
CHMP je menil, da je bilo dokazano, da je zdravilo Zerbaxa učinkovito ozdravilo okužbe pri proučevanih bolnikih, vendar pri tem izpostavil, da je v študijah sodelovalo omejeno število bolnikov z zapletenimi okužbami sečil.
The CHMP considered that, despite the side effects reported with Perjeta, the overall safety profile was acceptable.
Menil je, da je kljub neželenim učinkom, o katerih so poročali pri uporabi zdravila Perjeta, na splošno varnostni profil sprejemljiv.
The CHMP considered the lack of specific therapies for factor X deficiency, and concluded that Coagadex has been shown to be effective at treating and preventing the occurrence of bleeding in patients above 12 years with the condition.
CHMP je upošteval premajhno število specifičnih zdravljenj pomanjkanja faktorja X in zaključil, da se je zdravilo Coagadex izkazalo za učinkovito pri zdravljenju in preprečevanju pojavov krvavitev pri bolnikih, starejših od 12 let.
The CHMP considered the side effects to be manageable and included in the product information recommendations for doctors to help reduce the risks.
Odbor je menil, da so neželeni učinki obvladljivi in v navodilo za uporabo dodal priporočila za zdravnike, ki naj bi prispevala k zmanjšanju tveganj.
The CHMP considered Xigduo to be effective at controlling blood glucose levels; it also leads to weight loss, which is considered beneficial in patients with diabetes.
CHMP je menil, da je zdravilo Xigduo učinkovito pri uravnavanju ravni glukoze v krvi; poleg tega povzroči zmanjšanje telesne mase, kar je koristno za bolnike s sladkorno boleznijo.
The CHMP decided that Abilify’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Abilify večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Ablavar’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Ablavar večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Aclasta’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Aclasta večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Actos’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor CHMP je zaključil, da so koristi zdravila Actos večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Actraphane’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Actraphane večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Actrapid’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Actrapid večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Adcirca’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Adcirca večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Adrovance’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Adrovance večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Advate’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Advate večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Aerius’s benefits are greater than its risks for the relief of symptoms associated with allergic rhinitis or urticaria and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Aerius pri lajšanju simptomov alergijskega rinitisa ali urtikarije večji od z njim povezanih tveganj, in priporočil da se zanj odobri dovoljenje za promet.
The CHMP decided that Afinitor was shown to slow down disease progression in patients with advanced neuroendocrine tumours of pancreatic origin, advanced renal cell carcinoma and hormone-receptor- positive advanced breast cancer.
CHMP je zaključil, da se je zdravilo Afinitor izkazalo kot učinkovito pri upočasnitvi napredovanja bolezni pri bolnikih z napredovalim nevroendokrinim tumorjem pankreatičnega izvora, napredovalim rakom ledvičnih celic in napredovalim rakom dojke, pozitivnim na hormonske receptorje.
The CHMP decided that Aflunov’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zaključil je, da so koristi cepiva Aflunov večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Aldurazyme gives effective control of the symptoms of MPS I. The Committee decided that Aldurazyme’s benefits are greater than its risks and recommended that Aldurazyme be given marketing authorisation.
CHMP je zaključil, da zdravilo Aldurazyme zagotavlja učinkovit nadzor simptomov mukopolisaharidoze tipa I. Zaključil je, da so koristi zdravila Aldurazyme večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Ambirix’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Ambirix večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.