natgillin/translations-raw huggingface dataset:
The Committee decided that Procoralan’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Komitee otsustas, et Procoralani kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The Committee decided that Ranexa’s benefits are greater than its risks as an add-on treatment of the symptoms of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line anti-anginal medicines (such as beta-blockers and/or calcium antagonists).
Komitee otsustas, et Ranexa kasulikkus on suurem kui riskid, kui seda kasutatakse lisaravimina nendel stabiilse stenokardiaga patsientidel, kelle haigus stenokardia põhiravimitega (nt beetablokaatorid ja/või kaltsiumi antagonistid) ei allu piisavalt ravile või kellel nimetatud ravimeid kasutada ei saa.
The Committee decided that Reyataz’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Reyatazi kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
The Committee decided that Savene’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Savene kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
The Committee decided that Suboxone’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Komitee otsustas, et Suboxone kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
The Committee decided that Tandemact’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Tandemacti kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
The Committee decided that the medicine’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Arzerra kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The Committee decided that Tractocile’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Komitee leidis, et Tractocile kasulikkus on suurem kui sellega seotud riskid ja soovitas anda ravimile müügiloa
The Committee decided that Trizivir’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Triziviri kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
The Committee decided that Twynsta’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Twynsta kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
The Committee decided that Tysabri’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Komitee otsustas, et Tysabri kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
The Committee decided that Xagrid’s benefits are greater than its risks as second-line treatment in at-risk patients with essential thrombocythaemia.
Komitee otsustas, et Xagridi kasulikkus kasutamisel teise valiku ravimina essentsiaalse trombotsüteemiaga patsientide ravis on suurem kui sellega kaasnevad riskid.
The Committee decided that Xeplion’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Xeplioni kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
The Committee decided that ZIMULTI’s benefits are greater than its risks when used, in addition to diet and exercise, to treat obese patients and overweight patients with risk factors such as type 2 diabetes or dyslipidaemia.
Komitee otsustas, et ZIMULTI kasulikkus selle kasutamisel lisaks dieedile ja liikumisele rasvunud patsientide ning ülekaaluliste ja selliste ohuteguritega nagu II tüüpi suhkurtõbi või düslipideemia patsientide raviks on suurem kui sellega kaasnevad riskid.
The Committee decided that Zypadhera’s benefits are greater than its risks and recommended that Zypadhera be given marketing authorisation.
Inimravimite komitee otsustas, et Zypadhera kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
The Committee decided that, based on available published information, Tepadina’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et avaldatud andmete põhjal on Tepadina kasulikkus suurem kui kaasnevad riskid, ja soovitas anda Tepadina müügiloa.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Ecalta’s benefits are greater than its risks for the treatment of invasive candidiasis in adult patients.
Inimravimite komitee järeldas, et Ecalta kasulikkus täiskasvanud patsientidel invasiivse kandidiaasi ravis on suurem kui ravimiga kaasnevad riskid.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, although there were few systematic studies of Cystadane, the medicine is useful when added to existing treatments for homocystinuria, such as vitamin supplementation and using a special diet.
Inimtervishoius kasutatavate ravimite komitee jõudis otsusele, et kuigi Cystadane kohta on läbi viidud vähe süstemaatilisi uuringuid, on seda ravimit kasulik lisada homotsüstinuuria olemasolevale ravile, näiteks vitamiinilisandile ja eridieedi kasutamisele.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Krka has been shown to have comparable quality and to be bioequivalent to Plavix.
Inimravimite komitee otsustas, et vastavalt Euroopa Liidu nõuetele on tõendatud Clopidogrel Krka võrdväärne kvaliteet ja bioekvivalentsus ravimiga Plavix.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel TAD has been shown to have comparable quality and to be bioequivalent to Plavix.
Inimravimite komitee otsustas, et vastavalt Euroopa Liidu nõuetele on tõendatud Clopidogrel TADi võrdväärne kvaliteet ja bioekvivalentsus ravimiga Plavix.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ribavirin Teva Pharma B.V. has been shown to have comparable quality and to be bioequivalent to Rebetol.
Inimravimite komitee otsustas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Ribavirin Teva Pharma B.V. ravimiga Rebetol võrdväärne kvaliteet ja bioekvivalentsus.
The Committee for Medicinal products for Human Use (CHMP) considered that, in accordance with EU requirements, Omnitrope has been shown to have a comparable quality, safety and efficacy profile to Genotropin.
Inimtervishoius kasutatavate ravimite komitee leidis, et vastavalt ELi nõuetele on tõestatud, et Omnitrope kvaliteedi, ohutuse ja efektiivsuse profiil on Genotropiniga võrreldav.
The Committee for Medicinal Products for Human Use (CHMP) decided that Advagraf’s benefits are greater than its risks for the prophylaxis of transplant rejection in adult kidney and liver allograft recipients, and in the treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
Inimravimikomitee jõudis otsusele, et Advagrafi kasulikkus äratõukereaktsiooni profülaktikaks siiratud neeru või maksaga täiskasvanud patsientidel ja äratõukereaktsiooni raviks täiskasvanud patsientidel, kellel ravi muude immunosupressiivsete ravimitega ei toimi, on suurem kui Advagrafiga kaasnevad riskid.
The Committee for Medicinal Products for Human Use (CHMP) decided that Aldara’s benefits are greater than its risks for the treatment of external genital and perianal warts (condylomata acuminata), small basal cell carcinomas and nonhyperkeratotic, nonhypertrophic actinic keratoses in immunocompetent adult patients when other topical treatment options are contraindicated or less appropriate.
Inimravimite komitee jõudis otsusele, et Aldara kasulikkus välissuguorganite ja anaalpiirkonna teravikuliste tüügaskasvajate (condylomata acuminata), pindmiste basaalrakuliste kartsinoomide ja mittehüperkeratootiliste, mittehüpertroofiliste aktiinkeratooside raviks immunokompetentsetel täiskasvanud patsientidel, juhul kui teised paiksed ravivõimalused on vastunäidustatud või vähem sobivad, on suurem kui sellega kaasnevad riskid.
The Committee for Medicinal Products for Human Use (CHMP) decided that Alisade’s benefits are greater than its risks for the treatment of the symptoms of allergic rhinitis in patients aged six years or over.
Inimravimite komitee jõudis otsusele, et Alisade kasulikkus allergilise riniidi sümptomaatilises ravis vähemalt kuueaastastel patsientidel on suurem kui sellega kaasnevad riskid.
The Committee for Medicinal Products for Human Use (CHMP) decided that Altargo’s benefits are greater than its risks for the short term treatment of the following superficial skin infections:
Inimtervishoius kasutatavate ravimite komitee jõudis otsusele, et Altargo kasulikkus on suurem kui sellega kaasnevad riskid järgmiste pindmiste nahanakkuste lühiajalisel ravimisel:
The Committee for Medicinal Products for Human Use (CHMP) decided that Apidra’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Apidra kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
The Committee for Medicinal Products for Human Use (CHMP) decided that Ariclaim’s benefits are greater than its risks for the treatment of diabetic peripheral neuropathic pain in adults.
Inimravimite komitee otsustas, et Ariclaimi kasulikkus diabeetilise perifeerse neuropaatilise valu ravis täiskasvanutel on suurem kui sellega kaasnevad riskid.
The Committee for Medicinal Products for Human Use (CHMP) decided that Avamys’s benefits are greater than its risks for the treatment of the symptoms of allergic rhinitis in patients aged six years or over.
Inimravimite komitee jõudis otsusele, et Avamysi kasulikkus allergilise riniidi sümptomaatilises ravis vähemalt kuueaastastel patsientidel on suurem kui sellega kaasnevad riskid.
The Committee for Medicinal Products for Human Use (CHMP) decided that Azomyr’s benefits are greater than its risks for the relief of symptoms associated with allergic rhinitis or urticaria.
Inimravimite komitee otsustas, et Azomyri kasulikkus allergilise riniidi või nõgestõvega kaasnevate sümptomite leevendamisel on suurem kui kaasnevad riskid.
The Committee for Medicinal Products for Human Use (CHMP) decided that Azopt’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Azopti kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
The Committee for Medicinal Products for Human Use (CHMP) decided that Beromun’s benefits are greater than its risks as an adjunct to surgery for subsequent removal of the tumour so as to prevent or delay amputation, or in the palliative situation, for irresectable soft tissue sarcoma of the limbs, used in combination with melphalan via mild hyperthermic ILP.
Inimravimite komitee otsustas, et Beromuni kasulikkus on suurem kui sellega seotud riskid, kui ravimit kasutatakse enne kasvaja kirurgilist eemaldamist amputatsiooni vältimiseks või edasilükkamiseks või palliatiivses situatsioonis, kui jäseme pehmekudede sarkoomi ei ole võimalik kirurgiliselt eemaldada, ning kombinatsioonis melfalaaniga isoleeritud jäseme kergelt hüpertermilise perfusioonina.
The Committee for Medicinal Products for Human Use (CHMP) decided that Biopoin’s benefits are greater than its risks for the treatment of symptomatic anaemia in adults with chronic renal failure and adults with non-myeloid cancers who are receiving chemotherapy.
Inimravimite komitee otsustas, et kroonilise neerupuudulikkusega täiskasvanutel ja mittemüeloidse vähi tõttu keemiaravi saavatel patsientidel on Biopoin kasulikkus sümptomaatilise aneemia ravimisel suurem kui kaasnevad riskid.
The Committee for Medicinal products for Human Use (CHMP) decided that CEPROTIN’s benefits are greater than its risks for patients with severe congenital protein C deficiency.
Inimtervishoius kasutatavate ravimite komitee jõudis otsusele, et CEPROTINi kasulikkus proteiin C raske kaasasündinud vaegusega patsientide ravis on suurem kui sellega kaasnevad riskid.
The Committee for Medicinal Products for Human Use (CHMP) decided that Clopidogrel BMS’s benefits are greater than its risks in adults for the prevention of atherothrombotic events.
Inimravimite komitee otsustas, et Clopidogrel BMS-i kasulikkus täiskasvanute aterotrombootiliste nähtude ennetamisel on suurem kui sellega kaasnevad riskid.
The Committee for Medicinal Products for Human Use (CHMP) decided that Comtan’s benefits are greater than its risks as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa for use in patients with Parkinson’s disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Inimravimite komitee jõudis otsusele, et Comtani kasulikkus selle kasutamisel tavapäraste preparaatide levodopa/benserasiidi või levodopa/karbidopa täiendamiseks Parkinsoni tõvega ja annuse lõpu motoorsete kõikumistega patsientidel, keda ei saa nende ravimikombinatsioonidega stabiliseerida, on suurem kui ravimiga kaasnevad riskid.
The Committee for Medicinal Products for Human Use (CHMP) decided that Comtess’s benefits are greater than its risks as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa for use in patients with Parkinson’s disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Inimravimite komitee jõudis otsusele, et Comtessi kasulikkus selle kasutamisel tavapäraste preparaatide levodopa/benserasiidi või levodopa/karbidopa täiendamiseks Parkinsoni tõvega ja annuse lõpu motoorsete kõikumistega patsientidel, keda ei saa nende ravimikombinatsioonidega stabiliseerida, on suurem kui ravimiga kaasnevad riskid.
The Committee for Medicinal Products for Human Use (CHMP) decided that Cymbalta’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Cymbalta kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
The Committee for Medicinal Products for Human Use (CHMP) decided that Duloxetine Boehringer Ingelheim’s benefits are greater than its risks for the treatment of moderate to severe SUI and of diabetic peripheral neuropathic pain in adults.
Inimravimite komitee otsustas, et Duloxetine Boehringer Ingelheimi kasulikkus mõõduka kuni raske rõhkinkontinentsi ja diabeetilise perifeerse neuropaatilise valu ravimisel täiskasvanutel on suurem kui sellega kaasnevad riskid.
The Committee for Medicinal products for Human Use (CHMP) decided that Dynepo’s benefits are greater than its risks for the treatment of anaemia in patients with chronic renal failure.
Inimtervishoius kasutatavate ravimite komitee leidis, et Dynepo kasulikkus kroonilise neerupuudulikkusega patisentide aneemia ravis on suurem kui selle ohud.
The Committee for Medicinal Products for Human Use (CHMP) decided that Emadine’s benefits are greater than its risks for the symptomatic treatment of seasonal allergic conjunctivitis.
Inimravimite komitee otsustas, et Emadine kasulikkus hooajalise allergilise konjunktiviidi ravis on suurem kui sellega kaasnevad riskid.
The Committee for Medicinal Products for Human Use (CHMP) decided that Emtriva’s benefits are greater than its risks for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents.
Inimravimite komitee otsustas, et Emtriva kasulikkus retroviirustevastases kombineeritud ravis HIV— 1-nakkusega täiskasvanutel ja lastel on suurem kui sellega kaasnevad riskid.
The Committee for Medicinal Products for Human Use (CHMP) decided that Eporatio’s benefits are greater than its risks for the treatment of symptomatic anaemia in adults with chronic renal failure and adults with non-myeloid cancers who are receiving chemotherapy.
Inimravimite komitee otsustas, et kroonilise neerupuudulikkusega täiskasvanutel ja mittemüeloidse vähi tõttu keemiaravi saavatel patsientidel on Eporatio kasulikkus sümptomaatilise aneemia ravimisel suurem kui kaasnevad riskid.
The Committee for Medicinal Products for Human Use (CHMP) decided that Evra’s benefits are greater than its risks for female contraception.
Inimravimite komitee otsustas, et Evra kasulikkus naiste rasestumisvastase vahendina on suurem kui ravimiga kaasnevad riskid.
The Committee for Medicinal products for Human Use (CHMP) decided that Exubera’s benefits are greater than its risks in certain adult patients with diabetes when used as described in the Product information, and recommended that Exubera be given marketing authorisation.
Inimtervishoius kasutatavate ravimite komitee jõudis otsusele, et Exubera kasulikkus ületab ravimi kasutamisega seotud ohud, kui ravimit kasutatakse teatud täiskasvanud patsientidel, kellel on suhkurtõbi, vastavalt ravimi kirjeldusele, ning soovitas anda Exuberale müügiloa.
The Committee for Medicinal Products for Human Use (CHMP) decided that Faslodex’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Faslodexi kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
The Committee for Medicinal Products for Human Use (CHMP) decided that Fuzeon’s benefits are greater than its risks in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following classes, protease inhibitors, non-nucleoside reverse transcriptase inhibitors and nucleoside reverse transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens.
Inimravimite komitee jõudis otsusele, et Fuzeoni kasulikkus kombinatsioonis teiste retroviiruseravimitega HIV-1-nakkusega patsientide ravis, kelle puhul on varasem ravi vähemalt ühe ravimiga igast järgnevast retroviiruseravimi klassist – proteaasiinhibiitorid, mittenukleosiid- pöördtranskriptaasi inhibiitorid ja nukleosiid-pöördtranskriptaasi inhibiitorid – osutunud ebaefektiivseks või kes ei talunud varasemat ravi retroviiruseravimitega, on suurem kui sellega kaasnevad riskid.
The Committee for Medicinal products for Human Use (CHMP) decided that Helicobacter Test INFAI’s benefits are greater than its risks for the in vivo diagnosis of gastroduodenal H. pylori infection in adults, adolescents who are likely to have peptic ulcer disease, and children aged three to 11 years for the evaluation of the success of eradication treatment, or when invasive tests cannot be performed, or when there are discordant results arising from invasive tests.
Inimtervishoius kasutatavate ravimite komitee jõudis otsusele, et Helicobacter Test INFAI kasulikkus kaksteistsõrmiksoole H. pylori nakkuse in vivo diagnoosimisel täiskasvanutel, võimaliku peptilise haavandiga noorukitel ja kolme- kuni 11-aastastel lastel eradikatsioonravi edukuse hindamisel või kui invasiivseid teste ei saa teostada või kui invasiivsed testid on andnud vastuolulisi tulemusi, on suurem kui sellega kaasnevad riskid.
The Committee for Medicinal Products for Human Use (CHMP) decided that Hepsera’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Hepsera kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
The Committee for Medicinal products for Human Use (CHMP) decided that Humalog’s benefits are greater than its risks for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis, and for the initial stabilisation of diabetes mellitus.
Inimravimite komitee otsustas, et Humalogi kasulikkus diabeediga ja glükoosi normaalse homeostaasi hoidmiseks ja diabeedi esialgseks stabiliseerimiseks insuliiniravi vajavate täiskasvanute ja laste ravis on suurem kui ravimiga kaasnevad riskid.
The Committee for Medicinal Products for Human Use (CHMP) decided that ImmunoGam’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et ImmunoGami kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
The Committee for Medicinal Products for Human Use (CHMP) decided that INOmax’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee jõudis otsusele, et INOmaxi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The Committee for Medicinal Products for Human Use (CHMP) decided that Insulin Human Winthrop’s benefits are greater than its risks for the treatment of diabetes mellitus.
Inimravimite komitee otsustas, et Insulin Human Winthropi kasulikkus suhkurtõve ravis on suurem kui sellega kaasnevad riskid.
The Committee for Medicinal Products for Human Use (CHMP) decided that Integrilin’s benefits are greater than its risks when used to prevent early myocardial infarction.
Inimravimite komitee otsustas, et Integrilini kasulikkus on varase müokardiaalse infarkti ennetamisel suurem kui sellega kaasnevad riskid.
The Committee for Medicinal Products for Human Use (CHMP) decided that IntronA’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et IntronA kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The Committee for Medicinal Products for Human Use (CHMP) decided that Irbesartan BMS’s benefits are greater than its risks for the treatment of essential hypertension and of renal disease in patients with hypertension and type 2 diabetes mellitus.
Inimravimite komitee otsustas, et Irbesartan BMSi kasulikkus essentsiaalse hüpertensiooni ning hüpertensiooniga ja II tüüpi diabeediga neeruhaigete ravis on suurem kui ravimiga kaasnevad riskid.
The Committee for Medicinal Products for Human Use (CHMP) decided that Irbesartan Hydrochlorothiazide BMS’s benefits are greater than its risks for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
Inimravimite komitee otsustas, et Irbesartan Hydrochlorothiazide BMSi kasulikkus essentsiaalse hüpertensiooniga täiskasvanud patsientide raviks, kelle vererõhk ainult irbesartaani või hüdroklorotiasiidiga ei allu piisavalt ravile, on suurem kui ravimiga kaasnevad riskid.
The Committee for Medicinal Products for Human Use (CHMP) decided that Iressa’s benefits are greater than its risks for the treatment of adults with locally advanced or metastatic non-small cell lung cancer with activating mutations of EGFR.
Inimravimite komitee otsustas, et Iressa kasulikkus lokaalselt kaugelearenenud või metastaasidega mitteväikerakk-kopsuvähiga, millel on EGFR-i aktiveerivate geenide mutatsioon. täiskasvanute ravis suurem kui kaasnevad riskid.
The Committee for Medicinal products for Human Use (CHMP) decided that LeukoScan’s benefits are greater than its risks for determining the location and extent of infection/inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic foot ulcers.
Inimtervishoius kasutatavate ravimite komitee otsustas, et LeukoScani kasulikkus luuinfektsiooni / luupõletiku koha ja ulatuse leidmisel osteomüeliidi kahtlusega patsientidel, sealhulgas diabeetiliste jalahaavanditega patsientidel, ületab ravimi kasutamisega seotud ohud.