natgillin/translations-raw huggingface dataset:
Udvalget fandt, at fordelene ved Reyataz er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Reyataz.
The Committee decided that Reyataz’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget fandt, at fordelene ved Savene opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The Committee decided that Savene’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget fandt, at fordelene ved Suboxone opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The Committee decided that Suboxone’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget fandt, at fordelene ved Tandemact opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The Committee decided that Tandemact’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget fandt, at fordelene ved Tractocile opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The Committee decided that Tractocile’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget fandt, at fordelene ved Trizivir opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The Committee decided that Trizivir’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget fandt, at fordelene ved Twynsta opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The Committee decided that Twynsta’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget fandt, at fordelene ved Tysabri opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The Committee decided that Tysabri’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget fandt, at fordelene ved Xagrid opvejer risiciene ved andetvalgsbehandling af udsatte patienter med essentiel trombocytæmi.
The Committee decided that Xagrid’s benefits are greater than its risks as second-line treatment in at-risk patients with essential thrombocythaemia.
Udvalget fandt, at fordelene ved Zypadhera opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The Committee decided that Zypadhera’s benefits are greater than its risks and recommended that Zypadhera be given marketing authorisation.
Udvalget fandt, at forøgelsen med Kyprolis af den tid, hvor sygdommen ikke forværres, er klinisk meningsfuld.
It considered that the increase in time without the disease getting worse seen with Kyprolis was clinically meaningful.
Udvalget fandt, at Krystexxa imødekom et uopfyldt behov hos svært angrebne patienter, der ikke kan behandles effektivt med konventionelle metoder, da der ikke forelig- ger andre behandlingsmuligheder.
For severely affected patients who cannot be treated effectively with conventional methods, the Committee considered that Krystexxa addressed an unmet need, since no alternative treatments are available.
Udvalget fandt, at NexoBrid havde vist sig at være et effektivt middel til debridering og havde en acceptabel sikkerhedsprofil, og at det supplerer de eksisterende kirurgiske teknikker.
The Committee considered that NexoBrid was shown to be an effective debridement treatment with an acceptable safety profile which complements available surgical techniques.
Udvalget fandt, at Raplixa er effektivt til at afkorte den tid, det tager at standse let eller moderat blødning under operationer, når sædvanlig teknik såsom syning er utilstrækkelig.
The Committee considered that Raplixa is effective at reducing the time to stop mild or moderate bleeding during surgery when standard surgical techniques, such as stitches, are insufficient.
Udvalget fandt, at tilføjelse af dette lægemiddel til andre sukkersygelægemidler gav bedre kontrol af blodsukkeret, og at det var værdifuldt at råde over en ekstra behandlingsmulighed for at kunne tilpasse behandlingen til den enkelte patient.
The Committee considered that adding this medicine to other diabetes medicines offers better control of blood glucose and having an alternative treatment option is valuable in individualising treatment.
Udvalget for Humanmedicinske Lægemidler (CHMP) bemærkede, at Wilsons sygdom er dødelig, og at der kan være alvorlige bivirkninger forbundet med de lægemidler, der allerede anvendes.
The Committee for Medicinal products for Human Use (CHMP) noted that Wilson’s disease is a fatal disease and the other medicines already being used for the disease can have severe side effects.
Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved Alisade er større end risiciene ved behandling af symptomer på allergisk rhinitis hos patienter fra seks år og derover.
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.
Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved Comtess opvejer risiciene som tillægsbehandling til sædvanlige præparater med levodopa/benserazid eller levodopa/carbidopa til patienter med Parkinsons sygdom og motoriske end-of-dose fluktuationer, når sygdommen ikke kan stabiliseres med sådanne kombinationsbehandlinger.
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.
Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved Dynepo er større end risiciene ved behandling af patienter med kronisk nyresvigt.
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.
Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved Fuzeon er større end risiciene i kombination med andre antiretrovirale lægemidler til behandling af hiv-1-smittede patienter, som har modtaget behandling med og som ikke har reageret på behandlinger, der indeholder mindst ét lægemiddel fra hver af de følgende lægemiddelklasser: proteasehæmmere, non-nukleoside reverse transkriptasehæmmere og nukleoside reverse transkriptasehæmmere, eller som ikke kunne tåle tidligere antiretrovirale behandlinger.
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.
Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved Monotard er større end risiciene ved behandling af diabetes.
The Committee for Medicinal products for Human Use (CHMP) decided that Monotard’s benefits are greater than its risks for the treatment of diabetes.
Udvalget for humanmedicinske lægemidler (CHMP) besluttede, at fordelene ved Nespo var større end risiciene til behandling af anæmi i forbindelse med kronisk nyresvigt hos voksne og pædiatriske patienter og symptomatisk anæmi hos voksne kræftpatienter med ikke-myeloid malignitet i kemoterapi.
The Committee for Medicinal Products for Human Use (CHMP) decided that Nespo’s benefits are greater than its risks for the treatment of anaemia associated with chronic renal failure in adults and paediatric patients, and of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved Starlix er større end risiciene ved behandling af type 2- diabetes i kombination med metformin hos patienter, som ikke er under kontrol trods modtagelse af den maksimale daglige dosis af metformin.
The Committee for Medicinal products for Human Use (CHMP) decided that Starlix’s benefits are greater than its risks for the treatment of type 2 diabetes, in combination with metformin, in patients who are not controlled despite receiving the maximum daily dose of metformin.
Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved Trazec er større end risiciene ved behandling af type 2- diabetes i kombination med metformin hos patienter, som ikke er under kontrol trods modtagelse af den maksimale daglige dosis af metformin.
The Committee for Medicinal products for Human Use (CHMP) decided that Trazec’s benefits are greater than its risks for the treatment of type 2 diabetes, in combination with metformin, in patients who are not controlled despite receiving the maximum daily dose of metformin.
Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved Ultratard er større end risiciene ved behandling af diabetes.
The Committee for Medicinal products for Human Use (CHMP) decided that Ultratard’s benefits are greater than its risks for the treatment of diabetes.
Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved Xenical er større end risiciene, i kombination med en mild lavkaloriediæt, til behandling af adipøse patienter med et BMI, der ligger over eller svarer til 30 kg/m2, eller overvægtige patienter (BMI ≥ 28 kg/m2) med hermed forbundne risikofaktorer.
The Committee for Medicinal Products for Human Use (CHMP) decided that Xenical’s benefits are greater than its risks in conjunction with a mildly hypocalorific diet for the treatment of obese patients with a BMI greater or equal to 30 kg/m2, or overweight patients (BMI ≥ 28 kg/m2) with associated risk factors.
Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at Biograstim i overensstemmelse med EU’s krav har en profil med hensyn til kvalitet, sikkerhed og virkning, som svarer til Neupogen.
The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Biograstim has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at de gavnlige virkninger af Ceprotin er større end risiciene for patienter med medfødt svær protein C-mangel.
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.
Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at Filgrastim ratiopharm i overensstemmelse med EU’s krav har en profil med hensyn til kvalitet, sikkerhed og virkning, som svarer til Neupogen.
The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Filgrastim ratiopharm has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at fordelene ved Avamys er større end risiciene ved behandling af symptomer på allergisk rhinitis hos patienter fra seks år.
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.
Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at fordelene ved Beromun opvejer risiciene som tillægsbehandling til operation med henblik på at forhindre eller forsinke amputation ved efterfølgende fjernelse af svulsten, samt til symptomlindrende behandling af ikke opererbart bløddelssarkom i lemmerne, anvendt i kombination med melfalan via let hypertermisk ILP.
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.
Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at fordelene ved Lysodren opvejer risiciene til behandling af fremskreden binyrebarkkræft, men at det ikke var bevist, at Lysodren virker ved binyrebarkkræft, der ikke forårsager store mængder steroidhormoner.
The CHMP decided that Lysodren’s benefits are greater than its risks for the treatment of advanced adrenal cortical carcinoma, but noted that the effect of Lysodren has not been established in adrenal cortical carcinoma that is not producing high levels of steroid hormones.
Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at Tevagrastim i overensstemmelse med EU’s krav har en profil med hensyn til kvalitet, sikkerhed og virkning, som svarer til Neupogen.
The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Tevagrastim has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Udvalget for Humanmedicinske Lægemidler (CHMP) har konkluderet, at fordelene ved Protopy er større end risiciene til behandling af moderat til svær atopisk dermatitis hos voksne og børn over to år, der ikke responderer tilfredsstillende på eller ikke tåler konventionelle behandlingsformer.
The Committee for Medicinal products for Human Use (CHMP) decided that Protopy’s benefits are greater than its risks for the treatment of moderate to severe atopic dermatitis in adults and children over the age of 2 who are not adequately responsive to or are intolerant of conventional therapies.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede derfor, at fordelene ved Imprida HCT er større end risiciene til behandling af essentiel hypertension hos voksne, hvis blodtryk allerede er tilstrækkeligt kontrolleret med en kombination af amlodipin, valsartan og hydrochlorthiazid.
The CHMP therefore decided that Imprida HCT’s benefits are greater than its risks for the treatment of essential hypertension in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan and hydrochlorothiazide.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Clopidogrel Acino Pharma GmbH i overensstemmelse med EU’s krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Plavix.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Acino Pharma GmbH has been shown to have comparable quality and to be bioequivalent to Plavix.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Clopidogrel Acino Pharma i overensstemmelse med EU’s krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Plavix.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Acino Pharma has been shown to have comparable quality and to be bioequivalent to Plavix.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Clopidogrel DURA i overensstemmelse med EU’s krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Plavix.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel DURA has been shown to have comparable quality and to be bioequivalent to Plavix.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Clopidogrel Krka i overensstemmelse med EU’s krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Plavix.
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.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Clopidogrel Qualimed i overensstemmelse med EU’s krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Plavix.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Qualimed has been shown to have comparable quality and to be bioequivalent to Plavix.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Clopidogrel Sandoz i overensstemmelse med EU’s krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Plavix.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Sandoz has been shown to have comparable quality and to be bioequivalent to Plavix.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Clopidogrel Teva i overensstemmelse med EU’s krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Plavix.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Teva has been shown to have comparable quality and to be bioequivalent to Plavix.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at de gavnlige virkninger af Quixidar er større end risiciene til forebyggelse og behandling af venøs tromboemboli, ustabil angina og myokardieinfarkt.
The Committee for Medicinal Products for Human Use (CHMP) decided that Quixidar’s benefits are greater than its risks in both the prevention and the treatment of VTEs, unstable angina and myocardial infarction.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at det er påvist, at Aerivio Spiromax er af sammenlignelig kvalitet og er bioækvivalent med Seretide Diskus.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Aerivio Spiromax has been shown to have comparable quality and to be bioequivalent to Seretide Diskus.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at det er påvist, at Airexar Spiromax er af sammenlignelig kvalitet og er bioækvivalent med Seretide Diskus.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Airexar Spiromax has been shown to have comparable quality and to be bioequivalent to Seretide Diskus.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Bortezomib Sun er sammenligneligt med Velcade.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Bortezomib Sun has been shown to be comparable to Velcade.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at det i overensstemmelse med EU’s krav er blevet påvist, at Clopidogrel TAD er af sammenlignelig kvalitet og er bioækvivalent med 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.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at det i overensstemmelse med EU’s krav er påvist, at Actelsar HCT er af sammenlignelig kvalitet og er bioækvivalent med MicardisPlus.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Actelsar HCT has been shown to have comparable quality and to be bioequivalent to MicardisPlus.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at det i overensstemmelse med EU’s krav er påvist, at Bortezomib Accord er sammenligneligt med Velcade.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Bortezomib Accord has been shown to be comparable to Velcade.
Udvalget for humanmedicinske lægemidler (CHMP) konkluderede, at det i overensstemmelse med EU’s krav er påvist, at Caspofungin Accord er sammenligneligt med Cancidas.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Caspofungin Accord has been shown to be comparable to Cancidas.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at det i overensstemmelse med EU’s krav er påvist, at Imatinib Accord er af sammenlignelig kvalitet og er bioækvivalent med Glivec.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Imatinib Accord has been shown to have comparable quality and to be bioequivalent to Glivec.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at det i overensstemmelse med EU’s krav er påvist, at Ribavirin Teva Pharma B.V. er af sammenlignelig kvalitet og er bioækvivalent med Rebetol.
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.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at det i overensstemmelse med EU’s krav er påvist, at Tolucombi er af sammenlignelig kvalitet og er bioækvivalent med MicardisPlus.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Tolucombi has been shown to have comparable quality and to be bioequivalent to MicardisPlus.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at det i overensstemmelse med EU’s krav er påvist, at Zonisamid Mylan er af sammenlignelig kvalitet og er bioækvivalent med Zonegran.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Zonisamide Mylan has been shown to have comparable quality and to be bioequivalent to Zonegran.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Docetaxel Teva i overensstemmelse med EU’s krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Taxotere.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Docetaxel Teva has been shown to have comparable quality to Taxotere.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Advagraf opve- jer risiciene ved forebyggelse af afstødning af allotransplantater af lever og nyre hos voksne patienter og til behandling af afstødning af allotransplantater hos voksne patienter, hos hvem andre immun- dæmpende lægemidler ikke virker.
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.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Altargo er større end risiciene ved korttidsbehandling af følgende overfladiske hudinfektioner:
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:
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Ariclaim er større end risiciene ved behandling af diabetiske perifere neuropatiske smerter hos voksne.
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.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Biopoin er større end risiciene ved Biopoin til behandling af symptomatisk anæmi hos voksne med kronisk nyreinsufficiens og voksne med ikke-myeloid kræft, der får kemoterapi.
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.