natgillin/translations-raw huggingface dataset:
CHMP konkluderede, at det i overensstemmelse med EU’s krav er blevet påvist, at Zoledronic acid Teva Pharma er sammenlignelig med Aclasta.
The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Teva Pharma has been shown to be comparable to Aclasta.
CHMP konkluderede, at det i overensstemmelse med EU’s krav er påvist, at Nevirapin Teva er af sammenlignelig kvalitet og er bioækvivalent med Viramune.
The CHMP concluded that, in accordance with EU requirements, Nevirapine Teva has been shown to have comparable quality and to be bioequivalent to Viramune.
CHMP konkluderede, at det i overensstemmelse med EU’s krav er påvist, at Zoledronsyre Teva er sammenlignelig med Zometa.
The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Teva has been shown to be comparable to Zometa.
CHMP konkluderede, at det var påvist, at Anoro var effektivt til at forbedre lungefunktion og symptomer ved KOL, dels i sammenligning med placebo, dels i sammenligning med de enkelte komponenter hver for sig og med tiotropium.
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.
CHMP konkluderede, at det var påvist, at Laventair var effektivt til at forbedre lungefunktion og symptomer ved KOL, dels i sammenligning med placebo, dels i sammenligning med de enkelte komponenter hver for sig og med tiotropium.
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.
CHMP konkluderede, at det var påvist, at Nuwiq var effektivt til behandling og forebyggelse af blødning hos patienter med hæmofili A. Nuwiq var desuden effektivt til at forebygge og behandle blødning ved operationer, og det havde samme virkning som andre faktor VIII-produkter.
The CHMP concluded that Nuwiq has been shown to be effective at treating and preventing the occurrence of bleeding in patients with haemophilia A. Nuwiq was also effective in preventing and treating bleeding in relation to surgery bleeding episodes, with effects similar to other factor VIII products.
CHMP konkluderede, at Docetaxel Accord er påvist at svare til Taxotere i overensstemmelse med EU- reglerne.
The CHMP concluded that, in accordance with EU requirements, Docetaxel Accord has been shown to be comparable to Taxotere.
CHMP konkluderede, at Docetaxel Teva Pharma i overensstemmelse med EU’s krav har vist sig at være sammenligneligt med Taxotere.
The CHMP concluded that, in accordance with EU requirements, Docetaxel Teva Pharma has been shown to be comparable to Taxotere.
CHMP konkluderede, at Ecansya i overensstemmelse med EU’s krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Xeloda.
The CHMP concluded that, in accordance with EU requirements, Ecansya has been shown to have comparable quality and to be bioequivalent to Xeloda.
CHMP konkluderede, at Esmya er påvist at være effektivt til at mindske blødninger og anæmi og fibromernes størrelse hos kvinder, der skulle have fjernet deres fibromer ved operation.
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.
CHMP konkluderede, at Filgrastim Hexal i overensstemmelse med EU’s krav har vist sig at have en kvalitet, sikkerhed og virkning, som er sammenlignelig med Neupogen.
The CHMP decided that, in accordance with EU requirements, Filgrastim Hexal has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
CHMP konkluderede, at fordelene ved Abilify opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The CHMP decided that Abilify’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Afinitor opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Afinitor.
The CHMP concluded that the benefits of Afinitor are greater than its risks and recommended that it be granted marketing authorisation.
CHMP konkluderede, at fordelene ved Alimta er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The CHMP concluded that Alimta’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Arixtra er større end risiciene, og anbefalede udstedelse af en markedsføringstilladelse.
The CHMP decided that Arixtra’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Baraclude opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Baraclude.
The CHMP concluded that Baraclude’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved behandling med Ameluz oversteg de få og hovedsageligt milde bivirkninger, og at Ameluz var mere effektivt og i et vist omfang sikrere end det sædvanlige alternativ.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of treatment with Ameluz were greater than the few and mostly mild side effects, and that Ameluz was more effective and somewhat safer than the standard alternative.
CHMP konkluderede, at fordelene ved Benlysta opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Benlysta.
The Committee decided that Benlysta’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Betaferon opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Betaferon.
The CHMP decided that Betaferon’s benefits are greater than its risks and recommended that Betaferon be granted marketing authorisation.
CHMP konkluderede, at fordelene ved Brinavess opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Brinavess.
The CHMP decided that Brinavess’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Caprelsa opvejer risiciene hos patienter med både aggressiv og symptomgivende sygdom, da de har akut brug for behandling.
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.
CHMP konkluderede, at fordelene ved Ceplene er større end risiciene og anbefalede udstedelse af markedsføringstilladelse.
The CHMP decided that Ceplene’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Cholestagel opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The CHMP concluded that Cholestagel’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Crixivan opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse.
The CHMP decided that Crixivan’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Daronrix opvejer risiciene, og at den er bevist at være velegnet som modelvaccine til forberedelse mod udbrud af en influenzapandemi.
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.
CHMP konkluderede, at fordelene ved Efient er større end risiciene, når det gives sammen med aspirin for at forhindre aterotrombotiske hændelser hos patienter med akut koronarsyndrom, der gennemgår primær eller forsinket perkutan koronarintervention.
The CHMP decided that Efient’s benefits are greater than its risks, when given together with aspirin, for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing primary or delayed percutaneous coronary intervention.
CHMP konkluderede, at fordelene ved Firdapse er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Firdapse.
The CHMP decided that Firdapse’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Forxiga overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The CHMP concluded that the benefits of Forxiga outweigh its risks and recommended that it be granted marketing authorisation.
CHMP konkluderede, at fordelene ved Gilenya til behandling af recidiverende-remitterende MS er klart påvist, og bemærkede, at endnu en fordel er, at det skal tages gennem munden.
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.
CHMP konkluderede, at fordelene ved Halaven er større end risiciene, og anbefalede udstedelse af en markedsføringstilladelse.
The CHMP decided that Halaven’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Hizentra er større end risiciene, og anbefalede, at der udstedes markedsføringstilladelse for Hizentra.
It decided that Hizentra’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Intrinsa opvejede risiciene og anbefalede udstedelse af markedsføringstilladelse for Intrinsa.
The CHMP decided that Intrinsa’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Ixiaro opvejer risiciene, og bemærkede, at man havde indstillet produktionen af den eneste alternative vaccine til beskyttelse mod japansk encephalitis, som var i brug uden for Asien.
The CHMP decided that Ixiaro’s benefits are greater than its risks and noted that the production of the only other vaccine for protection against Japanese encephalitis that was in use outside Asia had been discontinued.
CHMP konkluderede, at fordelene ved Jevtana er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Jevtana.
It decided that Jevtana’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Ketek opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The CHMP concluded that Ketek’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Kivexa opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Kivexa.
The CHMP decided that Kivexa’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Lumark overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The CHMP concluded that the benefits of Lumark outweigh the risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved NovoSeven er større end risiciene ved behandling af blødningsepisoder og forebyggelse af blødning hos personer, der gennemgår kirurgiske indgreb eller invasive procedurer, hos patienter med medfødt hæmofili, erhvervet hæmofili, medfødt faktor VII- mangel eller Glanzmanns trombasteni.
The CHMP decided that NovoSeven’s benefits are greater than its risks for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in patients with congenital haemophilia, acquired haemophilia, congenital factor VII deficiency or Glanzmann’s thrombasthenia.
CHMP konkluderede, at fordelene ved NutropinAq opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The CHMP concluded that NutropinAq’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Pandemic Influenza Vaccine H5N1 Baxter AG var større end risiciene i alle de undersøgte grupper, og anbefalede udstedelse af en markedsføringstilladelse for Pandemic Influenza Vaccine H5N1 Baxter AG.
The CHMP decided that Pandemic Influenza Vaccine H5N1 Baxter AG’s benefits are greater than its risks in all age groups investigated and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Possia opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The CHMP decided that Possia’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Pregabalin Pfizer overstiger risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Pregabalin Pfizer.
The CHMP decided that Pregabalin Pfizer’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnosticser større end risiciene, og anbefalede, at der blev udstedt markedsføringstilladelse for Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
The CHMP decided that Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Prevenar opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse for Prevenar.
The CHMP decided that Prevenar’s benefits are greater than its risks and recommended that Prevenar be given marketing authorisation.
CHMP konkluderede, at fordelene ved Privigen opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The CHMP concluded that Privigen’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Riprazo HCT er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Riprazo HCT.
The CHMP decided that Riprazo HCT’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved RoActemra opvejer risiciene, og anbefalede, at det godkendes til anvendelse.
The CHMP decided that RoActemra’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Ruconest er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The CHMP decided that Ruconest’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Sebivo opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse.
The CHMP decided that Sebivo’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Signifor opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The CHMP concluded that the benefits of Signifor outweigh its risks and recommended that it be granted marketing authorisation.
CHMP konkluderede, at fordelene ved Stalevo opvejer risiciene til behandling af patienter med Parkinsons sygdom ved motoriske end-of-dose fluktuationer, der ikke stabiliseres ved behandling med levodopa/dopa decarboxylasehæmmere.
The CHMP decided that Stalevo’s benefits are greater than its risks for the treatment of patients with Parkinson’s disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase inhibitor treatment.
CHMP konkluderede, at fordelene ved Tasmar opvejer risiciene som tillægsbehandling til levodopa/benserazid eller levodopa/carbidopa hos patienter med levodopa-følsom Parkinsons sygdom af ukendt årsag og motoriske fluktuationer og som ikke reagerer på eller tolerer andre COMT-hæmmere.
The CHMP decided that Tasmar’s benefits are greater than its risks in combination with levodopa/benserazide or levodopa/carbidopa for use in patients with levodopa-responsive idiopathic Parkinson’s disease and motor fluctuations, who failed to respond to or are intolerant of other COMT inhibitors.
CHMP konkluderede, at fordelene ved Teysuno er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Teysuno.
The CHMP decided that Teysuno’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Thyrogen opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse for Thyrogen.
The CHMP decided that Thyrogen’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Vivanza opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Vivanza.
The CHMP decided that Vivanza’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Vpriv opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Vpriv.
The CHMP decided that Vpriv’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Yellox er større end risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Yellox.
The CHMP decided that Yellox’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Zelboraf opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The Committee concluded that benefits of Zelboraf are greater than its risks and recommended that it be granted marketing authorisation.
CHMP konkluderede, at fordelene ved Zevalin opvejer risiciene ved anvendelse som konsoliderende behandling efter remissionsinduktion hos ubehandlede patienter med follikulær lymfom og ved behandling af voksne patienter med CD20-positiv follikulær B-celle non-Hodgkins lymfom, som fik tilbagefald eller ikke responderede på behandlingen med rituximab.
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.
CHMP konkluderede, at fordelene ved Zinforo opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Zinforo.
The CHMP concluded that benefits of Zinforo are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at fordelene ved Zometa er større end risiciene og anbefalede udstedelse af markedsføringstilladelse.
The CHMP decided that Zometa’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at Incruse var påvist at være effektivt til at bedre lungefunktionen og symptomerne ved KOL.
The CHMP concluded that Incruse was shown to be effective at improving the lung function and symptoms of COPD.
CHMP konkluderede, at Invanz har vist sig effektivt, omend med et begrænset antal svære tilfælde i løbet af undersøgelserne, til behandling af maveinfektioner, ikke-hospitalserhvervet lungebetændelse, gynækologiske infektioner og fodinfektioner hos sukkersygepatienter.
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.
CHMP konkluderede, at Komboglyze bidrager til at sænke blodsukkerniveauet hos patienter, hvis blodsukkerniveau ikke er tilstrækkeligt kontrolleret med metformin alene, mens kombinationen af saxagliptin og metformin i én tablet kan hjælpe patienter, der allerede tager begge aktive stoffer, til at følge behandlingen korrekt.
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.
CHMP konkluderede, at lægemidlet bevirkede klinisk betydningsfuld forlængelse af den tid, patienterne levede uden forværring af sygdommen.
The CHMP concluded that the medicine showed a clinically relevant improvement in the time patients lived without their disease getting worse.
CHMP konkluderede, at lægemidlet kunne give en klinisk betydningsfuld reduktion i blodsukkeret hos patienter med type 2- sukkersyge, og at fordelene og risiciene var de samme som ved hvert aktivt stof for sig.
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.
CHMP konkluderede, at lægemidlets virkninger allerede var velkendte, da lægemidler indeholdende esomeprazol har været godkendt i EU siden 2000, og da dets fordele ved kortvarig behandling et påvist i undersøgelser, hvor symptomerne hos størstedelen af patienterne svandt i løbet af 2 uger.
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.
CHMP konkluderede, at Nivestim i overensstemmelse med EU’ krav har vist sig at have en kvalitet, sikkerhed og virkning, som er sammenlignelig med Neupogen.
The CHMP decided that, in accordance with EU requirements, Nivestim has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
CHMP konkluderede, at NovoEight er påvist at være effektivt til behandling og forebyggelse af blødningsepisoder og har en virkning svarende til andre faktor VIII-produkters.
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.
CHMP konkluderede, at Olanzapin Apotex i overensstemmelse med EU’s krav har vist sig at være af sammenlignelig kvalitet og bioækvivalent med Zyprexa og Zyprexa Velotab.
The CHMP concluded that, in accordance with EU requirements, Olanzapine Apotex has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab.
CHMP konkluderede, at Orencia havde en beskeden antiinflammatorisk effekt på reumatoid artritis, og at det i kombination med methotrexat mindskede forværringen af ledskader og forbedrede den fysiske funktion.
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.
CHMP konkluderede, at patienter med aggressivt non-Hodgkins B-celle-lymfom reagerede bedre på Pixuvri end på anden kræftmedicin.
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.
CHMP konkluderede, at Procoralan viste sig at være effektivt til behandling af kronisk angina og havde en acceptabel sikkerhedsprofil, som gjorde, at det kunne bruges som alternativ behandling af patienter, der ikke kan tage betablokkere, eller hvis sygdom ikke kan kontrolleres med disse.
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.
CHMP konkluderede, at Ratiograstim i overensstemmelse med EU’s krav har vist sig at have en kvalitet, sikkerhed og virkning, som er sammenlignelig med Neupogen.
The CHMP decided that, in accordance with EU requirements, Ratiograstim has been shown to have a comparable quality, safety and efficacy profile to Neupogen.