natgillin/translations-raw huggingface dataset:
The CHMP decided that Toujeo’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 Toujeo večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Toviaz’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Toviaz večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Tracleer’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Tracleer večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Travatan’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicine (CHMP) je zaključil, da so koristi zdravila Travatan večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Tresiba’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Tresiba večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Trisenox’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Trisenox večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Tygacil’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Tygacil večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Tyverb’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Tyverb večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Urorec’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Urorec večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Vaniqa’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 Vaniqa večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Vantavo’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Vantavo večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Velcade’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Velcade večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Velmetia’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Velmetia večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Ventavis’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Ventavis večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Vfend’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Vfend večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Viagra’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Viagra večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Vidaza’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Vidaza večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Vimpat’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Vimpat večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Viracept’s benefits are greater than its risks in antiviral combination treatment of HIV-1 infected adults, adolescents and children of three years of age and older.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Viracept pri kombiniranem protiretrovirusnem zdravljenju odraslih, mladostnikov in otrok, starih 3 leta ali več, okuženih z virusom HIV-1, večje od z njim povezanih tveganj.
The CHMP decided that ViraferonPeg’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila ViraferonPeg večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Viread’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Viread večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Visudyne’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 Visudyne večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Vivanza’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 Vivanza večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Volibris’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Volibris večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Vpriv’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Vpriv večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Xarelto’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Xarelto večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Xelevia’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 Xelevia večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Xeristar’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Xeristar večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Xgeva’s benefits are greater than its risks for patients with cancers involving solid tumours, and recommended that it be given marketing authorisation.
Odbor CHMP je zaključil, da so pri bolnikih s solidnimi tumorji koristi zdravila Xgeva večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Xiapex’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Xiapex večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Xolair’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Xolair večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Xyrem’s benefits are greater than its risks.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Xyrem večje od z njim povezanih tveganj.
The CHMP decided that Yellox’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Yellox večje od z njim povezanih tveganj, zato je priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Yttriga’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 Yttriga večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Zavesca’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Zavesca večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Zebinix’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Zebinix večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Zeffix’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Zeffix večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Zerit’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor CHMP je zaključil, da so koristi zdravila Zerit večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Zevalin’s benefits are greater than its risks as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma and for the treatment of adult patients with rituximab relapsed or refractory CD20-positive follicular B cell non Hodgkin's lymphoma.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Zevalin kot konsolidacijska terapija po indukciji remisije pri predhodno nezdravljenih bolnikih s folikularnim limfomom in za zdravljenje folikularnih celic B CD20+ pri odraslih bolnikih z ne-Hodgkinovim limfomom, ki se je po zdravljenju z rituksimabom ponovil ali je zanj neodziven, večje od z njim povezanih tveganj.
The CHMP decided that Zometa’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Zometa večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Zonegran’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Zonegran večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Zostavax’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 Zostavax večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Zutectra’s benefits are greater than its risks and recommended that Zutectra be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Zutectra večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP decided that Zyprexa Velotab’s benefits are greater than its risks and recommended that Zyprexa Velotab be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Zyprexa Velotab večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that Zyprexa’s benefits are greater than its risks and recommended that Zyprexa be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Zyprexa večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP decided that, for patients with Fabry disease, treatment with Fabrazyme might provide long- term clinical benefits.
CHMP je menil, da lahko zdravljenje z zdravilom Fabrazyme bolnikom s Fabryjevo boleznijo zagotovi dolgotrajne klinične koristi.
The CHMP decided that, in accordance with EU requirements, Nivestim has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Nivestim po kakovosti, varnosti in učinkovitosti primerljivo zdravilu Neupogen.
The CHMP did however note that, due to the limited effects of currently available treatments for Alzheimer’s disease, there is no strong evidence of an immediate improvement in the management of patients or in patient outcomes following PET scans with Vizamyl.
Vendar je odbor izpostavil, da zaradi omejenih učinkov trenutno razpoložljivih oblik zdravljenja Alzheimerjeve bolezni po slikanju PET z zdravilom Vizamyl ni trdnih dokazov o takojšnjem izboljšanju obravnave bolnikov ali izidov pri bolnikih.
The CHMP did however note that, due to the limited effects of currently available treatments for Alzheimer’s disease, there is no strong evidence that early diagnosis following PET scans with Neuraceq and early management of treatment will improve patient outcomes.
Odbor CHMP pa je izpostavil, da zaradi omejenih učinkov trenutno razpoložljivih zdravil za Alzheimerjevo bolezen ni trdnih dokazov o tem, da bi zgodnje odkritje bolezni s PET-preiskavami z zdravilom Neuraceq in zgodnje zdravljenje izboljšala izid pri bolnikih.
The CHMP did, however, note that, partly due to the limited effects of current treatments for Alzheimer’s disease, there is no strong evidence of an immediate improvement in the management of patients or in patient outcomes following PET scans with Amyvid.
Odbor CHMP je navedel še, da po preiskavah PET z zdravilom Amyvid – deloma zaradi omejenih učinkov trenutnih zdravljenj Alzheimerjeve bolezni – ne obstajajo trdni dokazi o takojšnjem izboljšanju obravnave bolnikov ali izidov za bolnike.
The CHMP further noted that there were no major or unexpected safety concerns with Eylea.
Nadalje je ugotovil, da ni večjih ali nepričakovanih pomislekov glede varnosti pri uporabi zdravila Eylea.
The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the conditional marketing authorisation as further explained in the European Public Assessment Report.
Odbor za zdravila za uporabo v humani medicini (CHMP) po obravnavi vloge meni, da je razmerje med tveganji in koristmi ugodno, da lahko priporoči izdajo pogojnega dovoljenja za promet z zdravilom, kot je podrobneje razloženo v evropskem javnem poročilu o oceni zdravila (EPAR).
The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the marketing authorisation under exceptional circumstances as further explained in the European Public Assessment Report.
Odbor za zdravila za uporabo v humani medicini (CHMP) po obravnavi vloge meni, da je razmerje med tveganji in koristmi ugodno in lahko priporoči izdajo dovoljenja za promet z zdravilom v izjemnih okoliščinah, kot je podrobneje razloženo v evropskem javnem poročilu o oceni zdravila.
The CHMP is of the opinion that pursuant to Article 8 of Regulation (EC) No.
Odbor za zdravila za uporabo v humani medicini CHMP meni, da v skladu s členom 8 Uredbe (ES) št.
The CHMP is of the opinion that Vantobra is similar to authorised orphan medicinal product(s) within the meaning of Article 3 of Commission Regulation (EC) No.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da je zdravilo Vantobra podobno odobrenemu zdravilu siroti/odobrenim zdravilom sirotam v smislu opredelitve iz člena 3 Uredbe Komisije (ES) št.
The CHMP noted that an on-going clinical study will provide confirmation on the long-term effectiveness.
Izpostavil je, da bo potekajoča klinična študija potrdila dolgoročno učinkovitost.
The CHMP noted that Arzerra was shown to be effective at treating patients with CLL (both previously untreated patients and patients who had not responded to previous treatment with fludarabine and alemtuzumab).
Ugotovil je, da se je zdravilo Arzerra izkazalo kot učinkovito pri zdravljenju bolnikov s kronično limfocitno levkemijo (tako tistih, ki predhodno niso bili zdravljeni, kot tistih, ki se niso odzvali na zdravljenje s fludarabinom in alemtuzumabom).
The CHMP noted that Atripla needs to be taken on an empty stomach to prevent certain side effects, but that this could result in low tenofovir levels in the blood.
CHMP je ugotovil, da je zdravilo Atripla treba jemati na prazen želodec, da se ublažijo nekateri neželeni učinki, da pa to lahko povzroči nizke ravni tenofovirja v krvi.
The CHMP noted that Bretaris Genuair was shown to be effective at improving the symptoms of COPD, and its beneficial effects are maintained for up to a year.
CHMP je ugotovil, da je zdravilo Bretaris Genuair učinkovito pri izboljševanju simptomov KOPB ter da njegovi koristni učinki trajajo vse do enega leta.
The CHMP noted that DepoCyte had shown effectiveness in lymphomatous meningitis when compared with the standard formulation of cytarabine, and that it could improve patients’ quality of life because fewer intrathecal injections are needed.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da je zdravilo DepoCyte izkazalo učinkovitost pri limfomatoznem meningitisu v primerjavi s standardno obliko citarabina ter da lahko prispeva k izboljšanju kakovosti bolnikovega življenja, saj je potrebnih manj intratekalnih injekcij.
The CHMP noted that effect of Pradaxa in preventing the formation of blood clots patients who have undergone a hip or knee replacement is comparable to that of enoxaparin.
Zaključil je, da je učinkovitost zdravila Pradaxa pri preprečevanju nastajanja krvnih strdkov pri bolnikih po operativni vstavitvi umetnega kolka ali kolena primerljiva z učinkovitostjo enoksaparina.
The CHMP noted that Eklira Genuair was shown to be effective at improving the symptoms of COPD, and its beneficial effects are maintained for up to a year.
CHMP je ugotovil, da je zdravilo Eklira Genuair učinkovito pri izboljševanju simptomov KOPB ter da njegovi koristni učinki trajajo vse do enega leta.
The CHMP noted that Enurev Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and was also seen to improve the symptoms of COPD.
Odbor CHMP je ugotovil, da je imelo zdravilo Enurev Breezhaler skromne, vendar koristne učinke za bolnike pri izboljšanju delovanja pljuč ter da je izboljšalo tudi simptome kronične obstruktivne pljučne bolezni.
The CHMP noted that Esbriet had a modest effect on slowing down the progression of the disease, as measured by FVC, without serious risks for patients.
CHMP je menil, da ima zdravilo Esbriet zmeren učinek na upočasnitev napredovanja bolezni, kakor je bilo izmerjeno s forsirano vitalno kapaciteto, brez resnega tveganja za bolnike.
The CHMP noted that for schizoaffective disorder, the medicine has been shown to be effective in treating manic as well as depressive episodes in adult patients.
Menil je, da se je zdravilo pri shizoafektivni motnji izkazalo kot učinkovito za zdravljenje epizod manije in depresije pri odraslih bolnikih.
The CHMP noted that for wet AMD Eylea was as effective as ranibizumab in maintaining patients’ vision after the first year of treatment.
CHMP je ugotovil, da je bilo zdravilo Eylea pri vlažni obliki starostne degeneracije makule pri ohranjanju vida bolnikov po prvem letu zdravljenja enako učinkovito kot ranibizumab.
The CHMP noted that HER2-positive breast cancer is an aggressive form of breast cancer which occurs in around one in five cases.
Odbor CHMP je upošteval, da je HER2-pozitivni rak dojk agresivna oblika raka, ki se pojavi pri približno enem od petih bolnikov z rakom dojk.
The CHMP noted that Hizentra can prevent serious bacterial infections in PID patients through weekly injections which may be given at home, while the side effects are not frequent or severe.
Odbor CHMP je menil, da lahko zdravilo Hizentra pri bolnikih s primarno imunsko pomanjkljivostjo z injiciranjem enkrat na teden, ki se lahko daje doma, preprečuje hude bakterijske okužbe, medtem ko neželeni učinki niso pogosti ali hudi.
The CHMP noted that Iclusig was shown to be an effective treatment for those patients with CML or Ph+ ALL who have limited treatment options.
Menil je, da se je zdravilo Iclusig izkazalo kot učinkovito za bolnike s KML ali Ph+ ALL z omejenimi možnostmi zdravljenja.
The CHMP noted that in children the immune system’s response to Prevenar 13 was comparable to that of Prevenar, which is already authorised for the protection of children against S. pneumoniae in the EU.
CHMP je ugotovil, da je bil pri otrocih imunski odziv na cepivo Prevenar 13 primerljiv z imunskim odzivom na cepivo Prevenar, ki je že odobreno v Evropski uniji (EU) za zaščito otrok pred okužbo z bakterijo S. pneumoniae.
The CHMP noted that inhaled tobramycin was the ‘gold standard’ for treating P. aeruginosa infection in patients with cystic fibrosis and that some patients cannot use the dry powder form because they cannot tolerate it.
CHMP je opozoril, da je inhaliranje tobramicina „zlati standard“ za zdravljenje okužb z bakterijo P. aeruginosa pri bolnikih s cistično fibrozo in da ga nekateri bolniki ne morejo jemati v obliki suhega praška, saj ga ne prenašajo.
The CHMP noted that it is likely that a H5N1 strain of the influenza will cause a pandemic in the future.
CHMP je menil, da bo sev gripe H5N1 v prihodnosti verjetno povzročil pandemijo.
The CHMP noted that Myocet has a lower risk of heart problems than conventional doxorubicin, while both medicines have similar levels of effectiveness.
Odbor za zdravila za uporabo v humani medicini (CHMP) je ugotovil, da je tveganje za pojav težav s srcem pri uporabi zdravila Myocet manjše kot pri uporabi konvencionalnega doksorubicina, obe zdravili pa sta približno enako učinkoviti.
The CHMP noted that Orfadin seems to be an effective treatment for HT-1, particularly if it is started early, before the patient’s liver is too damaged.
Odbor za zdravila za uporabo v humani medicini (CHMP) je ugotovil, da se zdravilo Orfadin zdi učinkovito pri zdravljenju dedne tirozinemije tipa 1, zlasti če se začne jemati dovolj zgodaj, preden so bolnikova jetra preveč poškodovana.
The CHMP noted that Ozurdex injection causes only minor trauma to the eyeball and the increase in intraocular pressure is considered to be manageable.
CHMP je ugotovil, da injiciranje zdravila Ozurdex v zrklu povzroči zgolj manjšo poškodbo, in meni, da je zvišanje intraokularnega tlaka obvladljivo.
The CHMP noted that Plenadren achieved satisfactory levels of cortisol during the treatment of patients with adrenal insufficiency.
CHMP je zaključil, da je bila med zdravljenjem bolnikov z adrenalno insuficienco z zdravilom Plenadren dosežena zadovoljiva raven kortizola.