natgillin/translations-raw huggingface dataset:
The CHMP decided that ViraferonPeg’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et ViraferonPegi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Viread’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Vireadi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Visudyne’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Visudyne kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Vivanza’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Vivanza kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Volibris’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Volibrise kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Vpriv’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Vprivi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Xarelto’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Xarelto kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Xeloda’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Xeloda kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Xeristar’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Xeristari kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda müügiloa.
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.
Inimravimite komitee otsustas, et Xgeva kasulikkus on soliidtuumoriga patsientidel suurem kui ravimiga kaasnevad riskid, ning soovitas anda ravimi müügiloa.
The CHMP decided that Xiapex’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Xiapexi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Xolair’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Xolairi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Xyrem’s benefits are greater than its risks.
Inimravimite komitee otsustas, et Xyremi kasulikkus ületab kaasnevaid riske.
The CHMP decided that Yellox’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Yelloxi kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
The CHMP decided that Yttriga’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Yttriga kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Zavesca’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Zavesca kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Zebinix’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Zebinixi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Zeffix’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Zeffixi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Zerit’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Zeriti kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
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.
Inimravimite komitee otsustas, et Zevalini kasulikkus on suurem kui sellega kaasnevad riskid, kui ravimit kasutatakse konsolideerivaks raviks pärast remissiooni tekkimist varem ravimata follikulaarse lümfoomiga patsientidel, ja kui Zevalini kasutatakse koos rituksimaabiga neil täiskasvanud patsientidel, kellel on relapsidega või refraktoorne CD20-positiivsete follikulaarsete B-rakkudega mitte-Hodgkini lümfoom.
The CHMP decided that Zometa’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Zometa kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Zonegran’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Zonegrani kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Zostavax’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Zostavaxi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda vaktsiini müügiloa.
The CHMP decided that Zutectra’s benefits are greater than its risks and recommended that Zutectra be given marketing authorisation.
Inimravimite komitee otsustas, et Zutectra kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Zyprexa Velotab’s benefits are greater than its risks and recommended that Zyprexa Velotab be given marketing authorisation.
Inimravimite komitee otsustas, et Zyprexa Velotabi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Zyprexa’s benefits are greater than its risks and recommended that Zyprexa be given marketing authorisation.
Inimravimite komitee otsustas, et Zyprexa kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that, for patients with Fabry disease, treatment with Fabrazyme might provide long- term clinical benefits.
Inimravimite komitee otsustas, et ravi Fabrazymega võib olla Fabry tõvega patsientidele kliiniliselt pikaajaliselt kasulik.
The CHMP decided that, in accordance with EU requirements, Nivestim has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Inimravimite komitee otsustas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Nivestim võrdväärne kvaliteet ning ohutus- ja efektiivsusprofiil ravimiga 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.
Inimravimite komitee märkis aga, et Alzheimeri tõve praeguste ravimeetodite vähese efektiivsuse tõttu puuduvad veenvad tõendid patsientide ravimeetodite või nende ravitulemuste viivitamatuks paranemiseks pärast Vizamyli PET-uuringuid.
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.
Inimravimite komitee märkis siiski, et Alzheimeri tõve praegu olemasolevate ravimeetodite piiratud toimete tõttu puuduvad kindlad tõendid, et varane diagnoos pärast PET-uuringuid Neuraceqiga ja ravi varane algus parandavad patsientide lõpptulemusi.
The CHMP further noted that there were no major or unexpected safety concerns with Eylea.
Komitee märkis veel, et Eylea kasutamisel ei täheldatud olulisi ega ootamatuid ohutusprobleeme.
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.
Inimravimite komitee on arvamusel, et riski ja kasu suhe on soodne, et soovitada anda tingimuslik müügiluba, mida on täpsemalt kirjeldatud Euroopa avalikus hindamisaruandes.
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.
Pärast taotluse arutamist on inimravimite komitee arvamusel, et ravimi riski ja kasulikkuse suhe on soodne ning seega tohib anda tingimusliku müügiloa, nagu on kirjeldatud Euroopa avalikus hindamisaruandes.
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.
Pärast taotluse arutamist on inimravimite komitee arvamusel, et ravimi riski/kasu suhe on soodne ning seega võib sellele anda müügiloa erandlikel tingimustel, nagu on kirjeldatud Euroopa avalikus hindamisaruandes.
The CHMP noted that an on-going clinical study will provide confirmation on the long-term effectiveness.
Komitee märkis, et praegu toimuv kliiniline uuring kinnitab pikaajalist efektiivsust.
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).
Inimravimite komitee märkis, et Arzerra efektiivsus on kroonilise lümfotsütaarse leukeemia ravis tõendatud nii varem ravimata kui ka varasemas fludarabiini ja alemtuzumaabi ravis ravivastuseta patsientidel.
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.
Inimravimite komitee märkis, et teatud kõrvalnähtude ennetamiseks peab Atriplat manustama tühja kõhuga, kuid see võib vähendada tenofoviiri sisaldust veres.
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.
Inimravimite komitee märkis, et Bretaris Genuair oli kroonilise obstruktiivse kopsuhaiguse sümptomite leevendamisel efektiivne ja et selle kasulik toime kestab kuni ühe aasta.
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.
Inimravimite komitee märkis, et DepoCyte on osutunud lümfomatoosse meningiidi ravis tsütarabiini standardsest ravimvormist efektiivsemaks ja et DepoCyte tõstab patsientide elukvaliteeti intratekaalsete süstide väiksema vajaduse tõttu.
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.
Inimravimite komitee märkis, et Pradaxa toime trombide tekkimise ennetamisel patsientidel, kellele on tehtud puusa- või põlveproteesimise operatsioon, on võrreldav enoksapariini toimega.
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.
Inimravimite komitee märkis, et Eklira Genuair oli kroonilise obstruktiivse kopsuhaiguse sümptomite parandamisel efektiivne ja et selle kasulik toime kestab kuni ühe aasta.
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.
Inimravimite komitee märkis, et Enurev Breezhaleri kasulikkus patsientidele kopsutalitluse parandamisel oli väike, kuid asjakohane, ning see leevendas ka kroonilise obstruktiivse kopsuhaiguse sümptomeid.
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.
Inimravimite komitee märkis, et Esbriet avaldas tagasihoidlikku haiguse süvenemist aeglustavat toimet, mida mõõdeti forsseeritud vitaalkapatsiteediga, ja ei põhjustanud patsientidele tõsist riski.
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.
Komitee märkis, et skisoafektiivse häirega täiskasvanud patsientidel on ravim osutunud efektiivseks nii maania- kui ka depressiooniepisoodide ravis.
The CHMP noted that for wet AMD Eylea was as effective as ranibizumab in maintaining patients’ vision after the first year of treatment.
Inimravimite komitee märkis, et Eylea oli AMD märja vormiga patsientide nägemise säilitamisel esimese raviaasta järel sama efektiivne kui ranibisumaab.
The CHMP noted that HER2-positive breast cancer is an aggressive form of breast cancer which occurs in around one in five cases.
Inimravimite komitee märkis, et HER2-positiivne rinnavähk on agressiivne vähivorm, mis esineb rinnavähijuhtudest ligikaudu viiendikul.
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.
Inimravimite komitee märkis, et Hizentra, mida süstitakse üks kord nädalas ja mida võib manustada kodus, võib ennetada tõsiseid bakteriaalsed infektsioone primaarse immuunpuudulikkuse sündroomiga patsientidel ning selle kõrvalmõjud ei ole sagedad ega rasked.
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.
Inimravimite komitee märkis, et Iclusigiga toimuva ravi efektiivsus on tõendatud nendel CMLiga või Ph+ ALLiga patsientidel, kelle ravivõimalused on piiratud.
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.
Inimravimite komitee märkis, et laste immuunsüsteemi vastus vaktsiinile Prevenar 13 oli võrreldav Prevenari vastusega, millel juba on Euroopa Liidus müügiluba laste kaitsmiseks bakteri S. pneumoniae vastu.
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.
Inimravimite komitee märkis, et inhaleeritav tobramütsiin on tsüstilise fibroosiga patsientide P. aeruginosa infektsiooni ravis range norm ja et mõni patsient ei saa kasutada kuiva pulbri ravimvormi, sest nad ei talu seda.
The CHMP noted that it is likely that a H5N1 strain of the influenza will cause a pandemic in the future.
Inimravimite komitee arvates on tõenäoline, et gripi H5N1-tüvi võib tulevikus põhjustada pandeemia.
The CHMP noted that Izba 30 microgram/ml is as effective as the 40 microgram/ml solution of travoprost.
Komitee märkis, et Izba lahus, mis sisaldab 30 μg/ml travoprosti, on sama efektiivne kui 40 μg/ml lahus.
The CHMP noted that Myocet has a lower risk of heart problems than conventional doxorubicin, while both medicines have similar levels of effectiveness.
Inimravimite komitee märkis, et Myoceti kasutamisel on südamehäirete tekkimise tõenäosus väiksem kui tavalise doksorubitsiini kasutamisel, kuigi mõlema ravimi efektiivsus on sarnane.
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.
Inimravimite komitee märkis, et Orfadin näib olevat HT-1 ravis efektiivne, eelkõige kui selle kasutamist alustatakse vara, enne patsiendi maksa liigset kahjustumist.
The CHMP noted that Ozurdex injection causes only minor trauma to the eyeball and the increase in intraocular pressure is considered to be manageable.
Inimravimite komitee märkis, et Ozurdexi süst põhjustab ainult väikese silmatrauma ning silma siserõhu suurenemist peetakse talutavaks.
The CHMP noted that Plenadren achieved satisfactory levels of cortisol during the treatment of patients with adrenal insufficiency.
Inimravimite komitee märkis, et Plenadreni võtnud patsientidel saavutas kortisooli sisaldus veres neerupealiste puudulikkusega patsientide jaoks rahuldava taseme.
The CHMP noted that Seebri 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.
Inimravimite komitee märkis, et Seebri Breezhaleri kasulikkus patsientidele kopsutalitluse parandamisel oli väike, kuid asjakohane, ning see leevendas ka kroonilise obstruktiivse kopsuhaiguse sümptomeid.
The CHMP noted that the benefit of Cyramza in prolonging the lives of gastric and gastro-oesophageal junction cancer patients was clearly demonstrated when Cyramza was given with paclitaxel.
Inimravimite komitee märkis, et Cyramza manustamisel koos paklitakseeliga on selgelt tõendatud Cyramza kasulikkus maovähi või gastroösofageaal-liidese vähiga patsientide elu pikendamisel.
The CHMP noted that the benefits of Bydureon, such as its effect on reducing the levels of HbA1c, compare well with those of comparator medicines and that its side effects are manageable.
Inimravimite komitee märkis, et Bydureoni kasulikkus, näiteks HbA1c-sisalduse vähendamisel, on võrdlusravimite omaga võrreldav ja kõrvalnähud on talutavad.
The CHMP noted that the degree of improvement seen with Senshio was comparable to that seen with oestrogen treatments that are applied to the vagina.
Inimravimite komitee märkis, et Senshio leevendava toime ulatus on võrreldav vaginaalse östrogeenraviga.
The CHMP noted that the effectiveness of Nplate had been shown in patients who had had their spleen removed, as well as in patients who had not had their spleen removed.
Inimravimite komitee märkis, et Nplate efektiivsus on tõestatud nii eemaldatud põrnaga kui ka eemaldamata põrnaga patsientidel.
The CHMP noted that the immune system’s response to Synflorix was comparable to that of the comparator vaccine, which is also authorised for the protection of children against S. pneumoniae in the EU.
Inimravimite komitee märkis, et immuunsüsteemi vastus Synflorixile oli võrreldav vastusega võrdlusvaktsiinile, millel juba on Euroopa Liidus müügiluba laste vaktsineerimiseks S. pneumoniae vastu.
The CHMP noted that the studies showed that Dexdor compared well with other sedatives and will serve as an additional alternative medicine for achieving lighter levels of sedation in suitable patients.
Inimravimite komitee oli seisukohal, et uuringute andmeil annab Dexdor teiste sedatiividega võrreldes häid tulemusi ja sobib kasutamiseks ravialternatiivina kergema sedatsioonitaseme saavutamiseks sobivatel patsientidel.
The CHMP noted that there is a need for a new effective treatment for bone disease in advanced cancer, particularly for patients with kidney problems since currently available treatments can be toxic for the kidneys.
Inimravimite komitee märkis, et kaugelearenenud vähi korral esinevate luukahjustuste jaoks on vaja uut efektiivset ravimit eelkõige neeruprobleemidega patsientidel, sest praegu saadaolevad ravimid võivad olla neerudele toksilised.
The CHMP noted that there was a need for fast-acting pain medicines for breakthrough pain in patients with cancer.
Inimravimite komitee märkis, et vähipatsientidel on läbimurdevalu raviks vaja kiiretoimelisi valuvaigisteid.
The CHMP noted that there was a need for new COPD treatments and that the main studies showed a modest benefit of Daxas in patients with severe COPD.
Inimravimite komitee märkis, et vajadus uute kroonilise obstruktiivse kopsuhaiguse ravimite järele on olemas ja et põhiuuringud näitasid Daxase tagasihoidlikku kasulikkust raske kopsuhaigusega patsientide ravis.
The CHMP noted that Thymanax’s benefits in terms of treating depression might be lower than seen with other antidepressants.
Inimravimite komitee märkis, et depressiooni ravimisel võib Thymanaxist saadav kasu olla väiksem kui muudel antidepressantidel.
The CHMP noted that Tovanor 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.
Inimravimite komitee märkis, et Tovanor Breezhaler kasulikkus patsientidele kopsutalitluse parandamisel oli väike, kuid asjakohane, ning see leevendas ka kroonilise obstruktiivse kopsuhaiguse sümptomeid.
The CHMP noted that Valdoxan’s benefits in terms of treating depression might be lower than seen with other antidepressants.
Inimravimite komitee märkis, et depressiooni ravimisel võib Valdoxanist saadav kasu olla väiksem kui muudel antidepressantidel.
The CHMP noted that Votubia has been shown to reduce the size of the brain tumours in adults and children with tuberous sclerosis and that this is expected to reduce the signs and symptoms of SEGA such as seizures, hydrocephalus (accumulation of fluid in the brain), and increased pressure within the brain.
Inimravimite komitee märkis, et uuringud tõendavad Votubia ajukasvajate ruumala vähendavat toimet tuberoosse skleroosiga täiskasvanutel ja lastel ning eeldatavalt leevendab see selliseid subependümaalse hiidrakulise astrotsütoomi haigusnähte ja sümptomeid nagu epilepsiaepisoodid, hüdrotsefaalia (ajuturse) ja koljusisese rõhu suurenemine.
The CHMP noted that Yervoy has been shown to improve survival in a condition where overall survival rates are low.
Inimravimite komitee märkis, et uuringu põhjal parandab Yervoy elulemust olukorras, kus üldise elulemuse määr on madal.
The CHMP noted that young children are most at risk, followed by adolescents, and that there is no other vaccine authorised in the EU for meningitis caused by this group of the bacterium.
Inimravimite komitee märkis, et suurimas ohus on väikelapsed ja samuti noorukid ning selle bakterirühma põhjustatud meningiidi vastu puudub Euroopa Liidus heaks kiidetud muu vaktsiin.
The CHMP noted that Zelboraf had been convincingly shown to improve overall survival and to delay the worsening of ‘BRAF V600 positive’ melanoma which has spread or cannot be surgically removed.
Inimravimite komitee märkis, et uuringud on veenvalt tõendanud, et Zelboraf pikendab üldist elulemust oluliselt ning lükkab edasi siiretega või kirurgiliselt eemaldamatu BRAF V600 mutatsiooni suhtes positiivse melanoomi progresseerumise.
The CHMP noted that Zinforo had shown activity in experimental models against certain bacteria against which other antibiotics belonging to the beta-lactam class do not work such as MRSA.
Inimravimite komitee märkis, et katses mõjus Zinforo teatud bakteritele, mille suhtes teised beetalaktaamide hulka kuuluvad antibiootikumid ei toimi, näiteks MRSA.
The CHMP noted that Zinforo was effective in treating complicated skin and soft tissue infections and community-acquired pneumonia and was generally well tolerated in both adults and children.
Inimravimite komitee märkis, et Zinforo oli naha ja pehmete kudede tüsistunud infektsioonide ning keskkonnatekkese pneumoonia ravis efektiivne ja üldiselt hästi talutav nii täiskasvanutel kui ka lastel.