natgillin/translations-raw huggingface dataset:
The CHMP also concluded that the 7 month delay in disease progression for patients with neuroendocrine tumours originating in the lungs or gut was clinically relevant, despite the known side effects of Afinitor.
Komitee otsustas ka, et hoolimata Afinitori teadaolevatest kõrvalnähtudest on haiguse progresseerumise edasilükkamine 7 kuu võrra kopsude ja soolte neuroendokriintuumoritega patsientidel kliiniliselt oluline.
The CHMP also concluded that Xolair (300 mg) was shown to significantly improve the symptoms of chronic spontaneous urticaria when used as add-on to the patients’ existing treatment, but noted that study data on long-term use beyond 6 months are limited.
Komitee järeldas ka, et Xolairi lisamine annuses 300 mg patsiendi senisele ravile leevendab oluliselt kroonilise spontaanse urtikaaria sümptomeid, kuid märkis, et puuduvad uuringuandmed pikaajalise (rohkem kui 6 kuud kestva) kasutamise kohta.
The CHMP also considered that although Firdapse is marketed in most EU member states, the size of the patient population is limited, resulting in limitations of the overall exposure to the product.
Inimravimite komitee otsustas ka, et kuigi Firdapset turustatakse enamikus ELi liikmesriikides, on patsientide populatsioon piiratud, millest tulenevalt on piiratud üldine kokkupuude ravimiga.
The CHMP also considered the seriousness of the disease and the lack of suitable alternative treatments for patients whose non-Hodgkin’s B cell lymphoma has come back or has not responded to other chemotherapy treatments.
Inimravimite komitee võttis arvesse ka haiguse raskusastet ja sobivate alternatiivsete ravimite puudumist patsientide jaoks, kelle agressiivne B-rakuline mitte-Hodgkini lümfoom retsidiveerus või kes ei saavutanud muude keemiaravi ravimitega piisavat ravivastust.
The CHMP also noted that giving the combination of dapagliflozin and metformin as a single tablet could provide an additional treatment option for patients with type 2 diabetes, and may improve adherence to treatment.
Komitee märkis, et dapagliflosiini ja metformiini kombinatsiooni manustamine ühe tabletina võib pakkuda 2. tüüpi suhkurtõvega patsientidele uue ravivõimaluse ja parandada ravirežiimi täitmist.
The CHMP also noted that giving the combination of dapagliflozin and metformin as a single tablet could provide an additional treatment option for patients with type 2 diabetes, and may improve adherence to treatment.
Komitee märkis, et dapagliflosiini ja metformiini kombinatsiooni manustamine ühe tabletina võib pakkuda II tüüpi diabeediga patsientidele uue ravivõimaluse ja parandada ravirežiimi täitmist.
The CHMP also noted that more studies are needed to further confirm the benefit of Lynparza, its effect on overall survival and its long-term safety.
Inimravimite komitee märkis ka, et vaja on lisauuringuid, et täiendavalt kinnitada Lynparza kasulikkust, toimet üldisele elulemusele ja pikaajalist ohutust.
The CHMP also noted that Pradaxa compared well with warfarin in reducing the risk of strokes in patients with atrial fibrillation without increasing the risk of major bleeding.
Inimravimite komitee märkis samuti, et Pradaxa oli võrreldav varfariiniga kodade virvendusega patsientidel insuldiriski vähendamisel, ilma et suureneks suurte verejooksude risk.
The CHMP also noted that the combination does not cause any unexpected side effects.
Inimravimite komitee märkis ka, et kombinatsioon ei põhjusta mingeid ootamatuid kõrvalnähtusid.
The CHMP also noted that the fact that the medicine is used once a day may help patients to comply with their treatment.
Inimravimite komitee märkis ka, et manustamine üks kord ööpäevas võib aidata patsientidel järgida raviskeemi.
The CHMP also noted that there were no major safety concerns with Anoro, with side effects being manageable, although the long-term safety data so far are limited.
Komitee märkis ka, et Anoroga ei ole suuri ohutusprobleeme, selle kõrvalnähud on hallatavad, kuigi pikaajalise ohutuse andmed on seni piiratud.
The CHMP also noted that there were no major safety concerns with Bretaris Genuair, with side effects being reversible and similar to other anticholinergic bronchodilator medicines.
Inimravimite komitee märkis samuti, et Bretaris Genuairiga ei ole suuri ohutusprobleeme, sest kõrvalnähud on pöörduvad ja sarnased teiste antikolinergiliste bronhodilataatorite kõrvalnähtudega.
The CHMP also noted that there were no major safety concerns with Eklira Genuair, with side effects being reversible and similar to other anticholinergic bronchodilator medicines.
Inimravimite komitee märkis samuti, et Eklira Genuairiga ei ole suuri ohutusprobleeme, sest kõrvalnähud on pöörduvad ja sarnased teiste antikolinergiliste bronhodilataatorite kõrvalnähtudega.
The CHMP also noted that there were no major safety concerns with Incruse, with side effects being manageable and similar to other antimuscarinic bronchodilator medicines.
Inimravimite komitee märkis samuti, et Incrusega ei ole suuri ohutusprobleeme, sest kõrvalnähud on pöörduvad ja sarnased teiste antimuskariinsete bronhodilataatorite kõrvalnähtudega.
The CHMP also noted that there were no major safety concerns with Laventair, with side effects being manageable, although the long-term safety data so far are limited.
Inimravimite komitee märkis samuti, et Laventairiga ei ole suuri ohutusprobleeme, selle kõrvalnähud on hallatavad, kuigi pikaajalise ohutuse andmed on seni piiratud.
The CHMP also noted the lack of effective alternative treatments for patients who have already tried standard treatments.
Lisaks sellele märkis inimravimite komitee, et standardravi saanud patsientidele ei ole muid efektiivseid raviviise.
The CHMP also noted, however, that there were limited data on the longer-term effects of the medicine and that further data should be provided by the company.
Inimravimite komitee märkis siiski, et ravimi pikaajalise toime kohta ei ole piisavalt andmeid ja ettevõte peab esitama lisaandmeid.
The CHMP asked the company to conduct a study to compare the 3 and 10 mg per kg bodyweight doses directly.
Inimravimite komitee palus ettevõttel läbi viia uuringu, et võrrelda omavahel annuseid 3 mg ja 10 mg kehamassi kg kohta.
The CHMP concluded that Alimta’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee järeldas, et Alimta kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP concluded that Anoro was shown to be effective at improving lung function and the symptoms of COPD when compared with placebo or the single components as well as with tiotropium.
Inimravimite komitee järeldas, et võrreldes platseebo või kummagi komponendiga eraldi ning ka tiotroopiumiga on Anoro osutunud kopsutalitluse parandamisel ja kroonilise obstruktiivse kopsuhaiguse sümptomite leevendamisel efektiivseks.
The CHMP concluded that Avaglim’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Avaglimi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda müügiloa.
The CHMP concluded that Baraclude’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee järeldas, et Baraclude kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda müügiloa.
The CHMP concluded that benefits of Zinforo are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee järeldas, et Zinforo kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP concluded that Caprelsa was shown to be effective in the treatment of medullary thyroid cancer although there were uncertainties about the size of the benefit in patients whose RET mutation status is negative or unknown.
Inimravimite komitee järeldas, et Caprelsa efektiivsus medullaarse kilpnäärmevähi ravis on tõendatud, ehkki ei ole päris selge, kui suur on sellest saadav kasu patsientidel, kellel ei ole RET geeni või kelle kohta seda ei teata.
The CHMP concluded that Carbaglu was effective in reducing blood ammonia to normal levels and decided that Carbaglu’s benefits are greater than its risks.
Inimravimite komitee järeldas, et Carbaglu oli efektiivne vere ammoniaagisisalduse normaliseerimisel ja otsustas, et Carbaglu kasulikkus on suurem, kui sellega kaasnevad riskid.
The CHMP concluded that Cetrotide is a safe and effective alternative to existing treatments for the prevention of premature ovulation.
Inimravimite komitee järeldas, et Cetrotide on ohutu ja efektiivne alternatiiv senistele enneaegset ovulatsiooni takistavatele ravimitele.
The CHMP concluded that Cholestagel’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Cholestageli kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda müügiloa.
The CHMP concluded that Corlentor was shown to be effective in long-term angina with an acceptable safety profile for it to provide an alternative treatment for patients who cannot take beta-blockers or whose disease is not controlled with them.
Inimravimite komitee järeldas, et Corlentor on pikaajalise stenokardia ravis efektiivne ning selle ohutusprofiil on vastuvõetav kasutamiseks alternatiivse ravimina patsientidel, kelle haigus ei allu ravile beetablokaatoritega või kes ei saa neid kasutada.
The CHMP concluded that Daronrix’s benefits outweighed its risks, and that it had shown its suitability as a mock-up vaccine in preparation for a pandemic flu outbreak.
Inimtervishoius kasutatavate ravimite komitee jõudis otsusele, et Daronrixi kasulikkus on suurem kui sellega kaasnevad riskid ning et see on osutunud sobivaks vaktsiini mudeliks valmistumaks gripipandeemiaks.
The CHMP concluded that Edistride was shown to be effective in lowering blood glucose levels in patients with type 2 diabetes, when given alone or in combination with other diabetes medicines with different mechanisms of action.
Inimravimite komitee järeldas, et Edistride on II tüüpi diabeediga patsientidel vere glükoosisisalduse vähendamisel efektiivne nii kasutamisel ainsa ravimina kui ka koos mitmesuguste toimemehhanismidega diabeediravimitega.
The CHMP concluded that Edurant, in combination with other antiretroviral medicines, was as effective as the main NNRTI currently used in the first-line treatment of adult patients infected with HIV-1.In addition, Edurant has also been shown to be effective in children aged 12 to 18 years of age.
Inimravimite komitee järeldas, et Edurant koos teiste retroviiruseravimitega on sama efektiivne kui peamine NNRTI-ravim, mida praegu kasutatakse HIV-1 nakkusega täiskasvanud patsientide esmavaliku ravis.Edurant oli efektiivne ka 12–18-aastastel noorukitel.
The CHMP concluded that Exelon has a modest effectiveness in treating the symptoms of Alzheimer’s dementia, although this does reflect an important benefit in some patients.
Inimravimite komitee järeldas, et Exeloni efektiivsus Alzheimeri dementsuse sümptomite ravis on olnud tagasihoidlik, kuigi mõnel patsiendil on sellest olnud oluliselt kasu.
The CHMP concluded that Forsteo’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee järeldas, et Forsteo kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP concluded that Forxiga was shown to be effective in lowering blood glucose levels in patients with type 2 diabetes, when given alone or in combination with other antidiabetes medicines with different mechanisms of actions.
Inimravimite komitee järeldas, et Forxiga on II tüüpi diabeediga patsientidel vere glükoosisisalduse vähendamisel efektiivne nii kasutamisel ainsa ravimina kui ka koos teiste mitmesuguste toimemehhanismidega diabeediravimitega.
The CHMP concluded that Incruse was shown to be effective at improving the lung function and symptoms of COPD.
Inimravimite komitee järeldas, et Incruse on kopsufunktsiooni parandamisel ja kroonilise obstruktiivse kopsuhaiguse sümptomite leevendamisel efektiivne.
The CHMP concluded that Jardiance was shown to be effective in lowering blood glucose levels in patients with type 2 diabetes, when given alone or in combination with other diabetes medicines with different mechanisms of action.
Inimravimite komitee leidis, et Jardiance osutus efektiivseks vere glükoosisisalduse vähendamisel II tüüpi diabeediga patsientidel, kui ravimit manustati ainsa ravimina või koos teiste diabeediravimitega, mille toimemehhanism on erinev.
The CHMP concluded that Ketek’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee järeldas, et Keteki kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP concluded that Komboglyze helps to reduce blood glucose levels in patients whose blood glucose levels are not adequately controlled by metformin alone, while the combination of saxagliptin and metformin in one tablet may help patients who already take both to follow their treatment correctly.
Inimravimite komitee otsustas, et Komboglyze aitab vähendada vere glükoosisisaldust patsientidel, kellel ainult metformiiniga ei ole piisavat vähenemist saavutatud, ning saksagliptiini ja metformiini kombinatsioon ühes tabletis võib aidata patsientidel, kes juba võtavad mõlemat toimeainet, järgida nõuetekohaselt raviskeemi.
The CHMP concluded that Laventair was shown to be effective at improving lung function and the symptoms of COPD when compared with placebo or the single components as well as with tiotropium.
Inimravimite komitee järeldas, et võrreldes platseebo või kummagi komponendiga eraldi ning ka tiotroopiumiga on Laventair osutunud kopsutalitluse parandamisel ja kroonilise obstruktiivse kopsuhaiguse sümptomite leevendamisel efektiivseks.
The CHMP concluded that NovoEight has been shown to be effective at treating and preventing bleeding episodes, with effects similar to other factor VIII products.
Inimravimite komitee järeldas, et on tõendatud NovoEighti efektiivsus veritsusepisoodide ravis ja ennetamises ning selle toimed on sarnased teiste VIII faktori ravimite omadega.
The CHMP concluded that NutropinAq’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee järeldas, et NutropinAqi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda müügiloa.
The CHMP concluded that Orencia had a modest anti-inflammatory effect in rheumatoid arthritis and, in combination with methotrexate, led to a reduction in the worsening of joint damage and an improvement in physical function.
Inimravimite komitee järeldas, et Orencial on reumatoidartriidi ravis tagasihoidlik põletikuvastane mõju ning annustamine koos metotreksaadiga vähendab liigesekahjustuste süvenemist ja parandab kehalist aktiivsust.
The CHMP concluded that patients with aggressive non-Hodgkin’s B cell lymphoma had a better response to treatment with Pixuvri than other cancer treatments.
Inimravimite komitee jõudis järeldusele, et Pixuvrit kasutavate agressiivse B-rakulise mitte-Hodgkini lümfoomiga patsientide ravivastus oli parem kui teisi ravimeid kasutanud patsientidel.
The CHMP concluded that Privigen’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee järeldas, et Privigeni kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP concluded that Procoralan was shown to be effective in long-term angina with an acceptable safety profile for it to provide an alternative treatment for patients who cannot take beta-blockers or whose disease is not controlled with them.
Inimravimite komitee järeldas, et Procoralan on pikaajalise stenokardia ravis efektiivne ning selle ohutusprofiil on vastuvõetav kasutamiseks alternatiivse ravimina patsientidel, kelle haigus ei allu ravile beetablokaatoritega või kes ei saa neid kasutada.
The CHMP concluded that Prometax has a modest effectiveness in treating the symptoms of Alzheimer’s dementia, although this does reflect an important benefit in some patients.
Inimravimite komitee järeldas, et Prometaxi efektiivsus Alzheimeri dementsuse sümptomite ravis on olnud tagasihoidlik, kuigi mõnel patsiendil on sellest olnud oluliselt kasu.
The CHMP concluded that Relvar Ellipta (92 /22 microgram and 184 /22 microgram) was shown to be effective at improving FEV1 in patients with asthma; it was also shown to effectively reduce the number of asthma flare-ups and, although this reduction was small, it was considered to be clinically relevant and similar to the effects of other inhalation medicines combining corticosteroids and long-acting beta-2 agonists.
Inimravimite komitee järeldas, et on tõestatud, et Relvar Ellipta (92/22 µg ja 184/22 µg) on astmaga patsientide FEV1 suurendamisel efektiivne; samuti on tõestatud, et ravim vähendas efektiivselt astma ägenemiste arvu ning kuigi vähenemine on väike, on see kliiniliselt oluline ja sarnaneb teiste kortikoide ja pikatoimelisi beeta-2-agoniste sisaldavate inhaleeritavate kombinatsioonravimite toimega.
The CHMP concluded that Revinty Ellipta (92 /22 microgram and 184 /22 microgram) was shown to be effective at improving FEV1 in patients with asthma; it was also shown to effectively reduce the number of asthma flare-ups and, although this reduction was small, it was considered to be clinically relevant and similar to the effects of other inhalation medicines combining corticosteroids and long-acting beta-2 agonists.
Komitee järeldas, et on tõestatud, et Revinty Ellipta (92/22 µg ja 184/22 µg) on astmaga patsientide FEV1 suurendamisel efektiivne; samuti on tõestatud, et ravim vähendas efektiivselt astma ägenemiste arvu ning kuigi vähenemine on väike, on see kliiniliselt oluline ja sarnaneb teiste kortikosteroidide ja pikatoimelisi beeta-2-agoniste sisaldavate inhaleeritavate kombinatsioonravimite toimega.
The CHMP concluded that Rivastigmine 1 A Pharma has a modest effectiveness in treating the symptoms of Alzheimer’s dementia, although this does reflect an important benefit in some patients.
Inimravimite komitee järeldas, et Rivastigmine 1 A Pharma efektiivsus Alzheimeri dementsuse sümptomite ravis on olnud tagasihoidlik, kuigi mõnel patsiendil on sellest olnud oluliselt kasu.
The CHMP concluded that Rivastigmine Hexal has a modest effectiveness in treating the symptoms of Alzheimer’s dementia, although this does reflect an important benefit in some patients.
Inimravimite komitee järeldas, et Rivastigmine Hexali efektiivsus Alzheimeri dementsuse sümptomite ravis on olnud tagasihoidlik, kuigi mõnel patsiendil on sellest olnud oluliselt kasu.
The CHMP concluded that Rivastigmine Sandoz has a modest effectiveness in treating the symptoms of Alzheimer’s dementia, although this does reflect an important benefit in some patients.
Inimravimite komitee järeldas, et Rivastigmine Sandozi efektiivsus Alzheimeri dementsuse sümptomite ravis on olnud tagasihoidlik, kuigi mõnel patsiendil on sellest olnud oluliselt kasu.
The CHMP concluded that Sylvant has been shown to have a beneficial effect by reducing tumour size and symptoms in patients with multicentric Castleman’s disease, and that this positive effect seems to be maintained over time.
Inimravimite komitee järeldas, et Sylvant on näidanud kasulikku toimet, vähendades hulgikoldelise Castlemani tõvega patsientidel kasvajate suurust ja haigussümptomeid, ning et see positiivne toime paistab aja jooksul püsivat.
The CHMP concluded that Telzir, which contains a prodrug of amprenavir, provides an advantage for patients, as the number of tablets they need to take is reduced when compared to the number of Agenerase capsules that they would need to take for the same dose of amprenavir.
Inimravimite komitee otsustas, et Telzir, mis sisaldab amprenaviiri eelravimit, on patsientidele kasulik, sest neil on vaja võtta sama amprenaviiriannuse saamiseks vähem tablette kui Agenerase kapsleid.
The CHMP concluded that the benefits of Afinitor are greater than its risks and recommended that it be granted marketing authorisation.
Inimravimite komitee järeldas, et Afinitori kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP concluded that the benefits of Caprelsa outweigh its risks in patients whose disease is both aggressive and causes symptoms, since they are in urgent need of treatment.
Inimravimite komitee otsustas, et Caprelsa kasulikkus sümptomeid põhjustava agressiivse kuluga haiguse puhul on suurem kui sellega kaasnevad riskid, sest sellistel haigetel puudub praegu muu ravi.
The CHMP concluded that the benefits of EndolucinBeta outweigh the risks and recommended that it be given marketing authorisation.
Inimravimite komitee järeldas, et EndolucinBeta kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP concluded that the benefits of Esmya outweigh its risks and recommended that it be granted marketing authorisation.
Inimravimite komitee järeldas, et Esmya kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP concluded that the benefits of Forxiga outweigh its risks and recommended that it be granted marketing authorisation.
Inimravimite komitee järeldas, et Forxiga kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP concluded that the benefits of Kalydeco are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee järeldas, et Kalydeco kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP concluded that the benefits of Lumark outweigh the risks and recommended that it be given marketing authorisation.
Inimravimite komitee järeldas, et Lumarki kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP concluded that the benefits of Signifor outweigh its risks and recommended that it be granted marketing authorisation.
Inimravimite komitee järeldas, et Signifori kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The CHMP concluded that the combination of linagliptin and metformin has been shown to be effective at lowering HbA1c levels, and that linagliptin 2.5 mg twice per day was as effective as 5 mg once per day, which is approved in the EU for use on its own and in combination with metformin and with metformin plus a sulphonylurea or insulin.
Inimravimite komitee järeldas, et linagliptiini ja metformiini kombineeritud kasutamine on HbA1c- sisalduse vähendamisel efektiivne ning et linagliptiin annuses 2,5 mg kaks korda ööpäevas on sama efektiivne kui 5 mg üks kord ööpäevas, mis on Euroopa Liidus heakskiidetud annus linagliptiini kasutamisel üksikravimina või koos metformiiniga või koos metformiini ja sulfonüüluurearavimi või insuliiniga.
The CHMP concluded that the effectiveness of Inlyta in treating patients with advanced renal cell carcinoma for whom treatment with Sutent or a cytokine failed has been demonstrated.
Inimravimite komitee järeldas, et Inlyta efektiivsus on tõestatud nende kaugelearenenud neerurakk- kartsinoomiga patsientide ravis, kelle ravi Sutenti või tsütokiinidega on ebaõnnestunud.
The CHMP concluded that the effectiveness of Tysabri in MS had been clearly shown but because of its safety profile, it should only be used in patients who have a real need for the medicine either because their disease has failed to respond to a disease-modifying therapy or is getting rapidly worse.
Inimravimite komitee järeldas, et Tysabri efektiivsus hulgiskleroosi ravis on selgesti tõestatud, kuid ravimi ohutusprofiili tõttu tohivad seda kasutada ainult patsiendid, kes seda ravimit tõesti vajavad – kas seetõttu, et neil puudub ravivastus haigust modifitseerivatele ravimitele, või süveneb nende haigus kiiresti.