natgillin/translations-raw huggingface dataset:
The CHMP concluded that the Invanz had shown its effectiveness, albeit with a limited number of severe cases treated during the studies in the treatment of abdominal infections, community-acquired pneumonia, gynaecological infections and diabetic foot infections.
Inimravimite komitee jõudis järeldusele, et Invanz on efektiivne kõhuõõne infektsioonide, keskkonnatekkelise pneumoonia, günekoloogiliste infektsioonide ja diabeetiliste jalainfektsioonide ravimisel, kuigi uuringute käigus ravitud raskete haigusjuhtude arv oli piiratud.
The CHMP concluded that the medicine could help produce a clinically meaningful reduction in blood glucose in patients with type 2 diabetes, and the benefits and risks were in line with those of the individual active substances.
Inimravimite komitee järeldas, et ravim võib aidata II tüüpi diabeediga patsientidel vähendada vere glükoosisisaldust kliiniliselt olulisel määral ning et kasulikkus ja riskid on kooskõlas individuaalsete toimeainete kasulikkuse ja riskidega.
The CHMP concluded that the medicine showed a clinically relevant improvement in the time patients lived without their disease getting worse.
Inimravimite komitee järeldas, et ravim pikendas kliiniliselt olulisel määral progresseerumiseta elulemust (aega, kui kaua patsiendid elavad haiguse süvenemiseta).
The CHMP concluded that the medicine’s effects were already well established, as esomeprazole-containing medicines have been authorised in EU countries since 2000, and that its short-term benefits had been demonstrated in studies where most patients’ symptoms cleared up in 2 weeks.
Inimravimite komitee oli seisukohal, et ravimi toime on juba hästi tõendatud, sest esomeprasooli sisaldavatel ravimitel on müügiluba Euroopa Liidu riikides alates 2000. aastast, ning selle lühiajalist kasulikkust on tõendatud uuringutes, kus enamiku patsientide sümptomid taandusid kahe nädala jooksul.
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.
Inimravimite komitee otsustas, et FEV1 vähene paranemine Colobreathe’i kasutamisel on piisav tõend ravimi efektiivsuse kohta, arvestades asjaolu, et suuremat paranemist ei saa eeldada patsientidel, kelle seisund oli enne stabiliseeritud tobramütsiini nebulisaatoriga.
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.
Inimravimikomitee järeldas, et tiomersaali väljajätmine vaktsiinidest ei vähendanud vaktsiinide efektiivsust B-hepatiidi viiruse eest kaitsmisel, kuid vähendas vaktsiinidega kaasnevaid riske.
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.
Inimravimite komitee järeldas, et relapseeruva-remiteeruva hulgiskleroosi ravis on Gilenya efektiivsuse kohta selged tõendid, ja märkis, et suukaudne manustamine on eelis.
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.
Inimravimite komitee järeldas, et Xalkoriga toimuval ravil on kasulik toime ALK-positiivse mitte- väikerakulise kopsuvähiga patsientide progresseerumiseta elumusele olenemata sellest, kas neid on varem ravitud.
The CHMP concluded that Vectibix’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee järeldas, et Vectibixi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP concluded that Xagrid had shown its effectiveness in lowering platelet counts in patients with essential thrombocythaemia.
Inimravimite komitee järeldas, et Xagrid on trombotsüütide sisalduse vähendamisel essentsiaalse trombotsüteemiaga patsientidel efektiivne.
The CHMP concluded that Yondelis’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Yondelise kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
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.
Inimravimite komitee järeldas, et Zyclara 3,75% kreem oli aktiinkeratoosi eemaldamisel nahalt efektiivne ja et selle kasutamine ei kujuta olulisi ohutusprobleeme.
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.
Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Abseamed võrdväärne kvaliteet ning ohutus- ja efektiivsusprofiil ravimiga 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.
Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Binocrit võrdväärne kvaliteet ja bioekvivalentsus ravimiga Eprex/Erypo.
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.
Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud Clopidogrel Teva Pharma B.V. võrdväärne kvaliteet ja bioekvivalentsus ravimiga Plavix.
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.
Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Clopidogrel Teva Pharma võrdväärne kvaliteet ja bioekvivalentsus ravimiga Plavix.
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.
Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Epoetin Alfa Hexal võrdväärne kvaliteet ja bioekvivalentsus ravimitega 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.
Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud Lamivudine Teva Pharma B.V. võrdväärne kvaliteet ja bioekvivalentsus ravimiga Epivir.
The CHMP concluded that, in accordance with EU requirements, Oprymea has been shown to have comparable quality and to be bioequivalent to Sifrol.
Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Oprymea võrdväärne kvaliteet ja bioekvivalentsus ravimiga Sifrol.
The CHMP concluded that, in accordance with EU requirements, Pioglitazone Accord has been shown to have comparable quality and to be bioequivalent to Actos.
Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Pioglitazone Accord võrdväärne kvaliteet ja bioekvivalentsus ravimiga Actos.
The CHMP concluded that, in accordance with EU requirements, Pioglitazone Actavis has been shown to have comparable quality and to be bioequivalent to Actos.
Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Pioglitazone Actavis Group võrdväärne kvaliteet ja bioekvivalentsus ravimiga Actos.
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.
Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Silapo võrdväärne kvaliteet ja bioekvivalentsus ravimiga 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.
Inimravimite komitee järeldas, et Olysio lisamine alfapeginterferoonile ja ribaviriinile suurendab oluliselt nakkuseta patsientide arvu nii varem ravimata kui ka ravitud patsientide hulgas.
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.
Inimravimite komitee otsustas, et kui loote talidomiidiga kokkupuute ennetamiseks on võetud väga ranged meetmed, on Thalidomide Celgene kasulikkus suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
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.
Komitee järeldas, et Ebymect on vere glükoosisisalduse reguleerimisel efektiivne; see põhjustab ka kehakaalu langust, mida peetakse diabeediga patsientidele kasulikuks.
The CHMP considered that adding Sovaldi to standard treatment is of benefit to patients.
Inimravimite komitee leidis, et Sovaldi lisamisest C-hepatiidi standardravile saavad patsiendid kasu.
The CHMP considered that Adempas led to significant improvements in exercise capacity in patients with CTEPH or PAH.
Komitee leidis, et Adempas parandas oluliselt kroonilise trombemboolse pulmonaalhüpertensiooni või pulmonaalse arteriaalse hüpertensiooniga patsientide koormustaluvust.
The CHMP considered that available study results, although not final, consistently showed the benefits of Keytruda in patients with advanced melanoma.
Inimravimite komitee leidis, et olemasolevatest uuringuandmetest, mis ei olnud siiski lõplikud, nähtus järjekindlalt, et Keytruda on kaugelearenenud melanoomiga patsientidele kasulik.
The CHMP considered that Benlysta, used as an add-on treatment, reduced disease activity in SLE without serious risk to the patient.
Inimravimite komitee leidis, et Benlysta vähendab täiendava ravina süsteemse erütematoosluupuse aktiivsust ega põhjusta seejuures patsiendile suurt riski.
The CHMP considered that Bexsero had been shown to produce a robust immune response to N. meningitidis group B and the risks were acceptable.
N. meningitidis B-rühma vastu, ning riskid on vastuvõetavad.
The CHMP considered that ChondroCelect was shown to be effective at treating defects in the knee cartilage between 1 and 5 cm2 in size, and that the safety profile was considered acceptable.
Inimravimite komitee võttis arvesse, et tõendatud on ChondroCelecti efektiivsus põlveliigese 1–5 cm2 suuruste kõhrekahjustuse ravis on tõestatud ja et ohutusprofiili peetakse vastuvõetavaks.
The CHMP considered that Defitelio had been shown to improve survival in patients with severe VOD.
Inimravimite komitee leidis, et on tõestatud, et Defitelio parandab raske venooklusiivse haigusega patsientide elulemust.
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.
Inimravimite komitee järeldas, et Esmya efektiivsus emakaverejooksu ja sellega seotud aneemia leevendamisel ning emakafibroidide mõõtmete vähendamisel naistel, keda tuleb opereerida, on tõendatud.
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.
Inimravimite komitee leidis, et tõenäoliselt aitab Fampyra ligikaudu kolmandikku liikumispuudega sclerosis multiplex´i patsientidest ning et ravivastusega patsiendid on võimalik kindlaks määrata varajases etapis, mis võimaldab teiste patsientide puhul ravi lõpetada.
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.
Inimravimite komitee järeldas, et Imbruvica efektiivsus kroonilise lümfotsütaarse leukeemia progresseerumise edasilükkamisel nii varem ravitud kui ka varem ravimata patsientide ravis on tõendatud.
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.
Inimravimite komitee leidis, et Nimenrix oli eri vanuserühma patsientidel bakteri N. meningitidis kõigi nelja rühma polüsahhariidide vastu immuunvastuse tekitamisel vähemalt sama efektiivne kui võrdlusvaktsiinid.
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.
Inimravimite komitee pidas veenvalt tõendatuks, et Opdivo pikendab teatud kaugelearenenud vähiga (melanoom, lamerakuline mitteväikerakk-kopsuvähk ja neerurakk-kartsinoom) patsientide elumust või haiguse süvenemiseni kuluvat aega.
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.
Inimravimite komitee pidas tõendatuks, et võrreldes platseeboga vähendab Plegridy iga 2 nädala tagant manustamisel ägenemiste ja remissioonidega kulgeva hulgikoldekõvastumusega patsientidel retsidiivide arvu ligikaudu 30%, mis on võrreldav teiste mittepegüleeritud beeta-interferooni sisaldavate hulgikoldekõvastumuse ravimite toimega ja mida peetakse kliiniliselt asjakohaseks.
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.
Inimravimite komitee leidis, et Revestive on lühikese soole sündroomiga täiskasvanud patsientidele kasulik, sest see vähendas vajatava parenteraalse toitelahuse kogust olulisel määral ja toime säilis pärast aastast ravi.
The CHMP considered that Reyataz’s effectiveness had been shown in patients aged at least 3 months and weighing at least 5 kg.
Inimravimite komitee otsustas, et Reyataz osutus efektiivseks vähemalt 5 kg kehamassiga vähemalt 3- kuustel patsientidel.
The CHMP considered that studies had shown that Stelara was effective in the treatment of adults and children over 12 years of age with moderate to severe plaque psoriasis.
Inimravimite komitee järeldas, et uuringud tõendasid Stelara efektiivsust täiskasvanute ja üle 12- aastaste laste mõõduka kuni raske naastulise psoriaasi ravis.
The CHMP considered that the ability of Jevtana to prolong overall survival in hormone refractory metastatic prostate cancer patients was clinically important.
Inimravimite komitee oli seisukohal, et Jevtana omadus pikendada hormoonrefraktoorse metastaatilise eesnäärmevähiga patsientide üldist elulemust on kliiniliselt oluline.
The CHMP considered that the anticancer effects of Xtandi had been clearly demonstrated and that its benefit in prolonging life is important for patients.
Inimravimite komitee leidis, et Xtandi vähivastane toime on veenvalt tõestatud ja Xtandist on patsientide elulemuse pikendamisel oluliselt kasu.
The CHMP considered that the benefit of Gazyvaro in prolonging the survival of CLL and FL patients before their disease worsened was clearly demonstrated.
Inimravimite komitee märkis, et Gazyvaro kasulikkus kroonilise lümfotsütaarse leukeemia ja follikulaarse lümfoomiga patsientide elu pikendamisel enne haiguse süvenemist on selgelt tõendatud.
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.
Inimravimite komitee otsustas, et Lonsurfi kasulikkus varem ravitud metastaatilise kolorektaalvähiga patsientide elumuse pikendamisel on kliiniliselt oluline.
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.
Komitee oli seisukohal, et Lynparza kasulikkus BRCA mutatsiooniga vähipatsientide progresseerumiseta elulemuse suurendamisel on kliiniliselt asjakohane.
The CHMP considered that the benefits of the medicine outweigh its risk and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Pradaxa kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP considered that the measures put in place are adequate to manage these risks.
Inimravimite komitee tunnistas nende riskide ohjamiseks võetud meetmeid piisavaks.
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.
Inimravimite komitee leidis, et ravimi mõju LDL-kolesterooli sisalduse vähendamisel oli homosügootse perekondliku hüperkolesteroleemiaga ja täitmata ravivajadustega patsientidele soodne.
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).
Inimravimite komitee oli arvamusel, et kuni 15 kuud uuritud Senshio ohutusprofiil vastab sarnase toimega ravimite (SERMid) ohutusprofiilile.
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.
Inimravimite komitee leidis, et ravi Harvoniga, kas koos ribaviriiniga või ilma, on väga kasulik paljudele C-hepatiidi viirusega patsientidele, sealhulgas siiratud maksaga ja/või kompenseeritud maksatsirroosiga patsientidele.
The CHMP considered that treatment with Sevelamer carbonate Zentiva has a beneficial effect in lowering blood phosphate levels without major safety concerns.
Inimravimite komitee leidis, et ravi ravimiga Sevelamer carbonate Zentiva avaldab kasulikku toimet vere fosfaadisisalduse vähendamisele ilma suurte ohutusprobleemideta.
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.
Inimravimite komitee leidis, et Zerbaxa osutus uuringutes osalenud patsientide infektsioonide ravimisel efektiivseks, kuid nentis, et uuringutes osales vaid vähesel arvul kuseteede tüsistunud infektsioonidega patsiente.
The CHMP considered that, despite the side effects reported with Perjeta, the overall safety profile was acceptable.
Komitee leidis, et kuigi Perjeta kohta on teatatud kõrvalnähte, on ravimi üldine ohutusprofiil vastuvõetav.
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.
Inimravimite komitee arvestas X teguri vaeguse spetsiifiliste ravimite puudumist ja järeldas, et Coagadex on olnud efektiivne verejooksude ravis ja ennetamisel üle 12-aastastel patsientidel.
The CHMP considered the side effects to be manageable and included in the product information recommendations for doctors to help reduce the risks.
Inimravimite komitee pidas ravimi kõrvalnähte talutavaks ja lisas ravimiteabesse soovitused arstidele, kuidas riske vähendada.
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.
Komitee järeldas, et Xigduo on vere glükoosisisalduse reguleerimisel efektiivne; see põhjustab ka kehakaalu langust, mida peetakse diabeediga patsientidele kasulikuks.
The CHMP decided that Abilify’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Abilify kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Ablavar’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Ablavari kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Aclasta’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Aclasta kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Actos’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Actose kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Actraphane’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Actraphane kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Actrapid’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Actrapidi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Adcirca’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Adcirca kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Adrovance’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Adrovance kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP decided that Advate’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Advate kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
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.
Inimravimite komitee otsustas, et Aeriuse kasulikkus allergilise riniidi või urtikaaria sümptomite leevendamisel on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
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.
Inimravimite komitee järeldas, et on tõendatud, et Afinitor aeglustab pankrease kaugelearenenud neuroendokriintuumorite, kaugelearenenud neerurakk-kartsinoomi ja kaugelearenenud hormoonretseptor-positiivse rinnavähi progresseerumist.
The CHMP decided that Aflunov’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Aflunovi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda vaktsiini müügiloa.
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.
Inimravimite komitee otsustas, et Aldurazyme on MPS I sümptomite reguleerimisel efektiivne.Komitee otsustas, et Aldurazyme kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
The CHMP decided that Ambirix’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Ambirixi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.