natgillin/translations-raw huggingface dataset:
Udvalget anbefalede, at Clopidogrel ratiopharm godkendes til anvendelse i EU.
The Committee recommended that Clopidogrel ratiopharm be approved for use in the EU.
Udvalget anbefalede, at der udføres yderligere undersøgelser vedrørende denne betænkelighed.
The Committee has recommended that further studies be carried out to investigate this concern.
Udvalget anbefalede, at Ebilfumin godkendes til anvendelse i EU.
The Committee recommended that Ebilfumin be approved for use in the EU.
Udvalget anbefalede, at Grastofil godkendes til anvendelse i EU.
The Committee recommended that Grastofil be approved for use in the EU.
Udvalget anbefalede, at Imatinib Accord godkendes til anvendelse i EU.
The Committee recommended that Imatinib Accord be approved for use in the EU.
Udvalget anbefalede, at Imatinib Actavis godkendes til anvendelse i EU.
The Committee recommended that Imatinib Actavis be approved for use in the EU.
Udvalget anbefalede, at Inflacam godkendes til anvendelse i EU.
The Committee recommended that Inflacam be approved for use in the EU.
Udvalget anbefalede, at Nordimet godkendes til anvendelse i EU.
The Committee recommended that Nordimet be approved for use in the EU.
Udvalget anbefalede, at Sevohale godkendes til anvendelse i EU.
The Committee recommended that Sevohale be approved for use in the EU.
Udvalget anbefalede, at Voriconazole Hospira godkendes til anvendelse i EU.
The Committee recommended that Voriconazole Hospira be approved for use in the EU.
Udvalget anbefalede, at Zoledronsyre Accord godkendes til anvendelse i EU.
The Committee recommended that Zoledronic acid Accord be approved for use in the EU.
Udvalget anså den overordnede sikkerhedsprofil for acceptabel trods de bivirkninger, der er indberettet med Perjeta.
The CHMP considered that, despite the side effects reported with Perjeta, the overall safety profile was acceptable.
Udvalget bemærkede desuden, at Activyl Tick Plus indeholder to aktive stoffer, hvorved man undgår at skulle bruge to forskellige veterinærlægemidler mod lopper og flåter.
The Committee also noted that Activyl Tick Plus combined two active substances thereby reducing the need to use two different products against flea and tick infestations.
Udvalget bemærkede desuden, at Adcetris' overordnede sikkerhedsprofil var acceptabel for disse patienter.
The Committee further noted that the overall safety profile of Adcetris was acceptable for these patients.
Udvalget bemærkede desuden, at der er et betydeligt potentiale for vekselvirkninger med andre lægemidler, hvilket fremgår af produktinformationen.
The Committee also noted that there is a significant potential for interactions with other medicines, and this has been reflected in the product information.
Udvalget bemærkede desuden, at der ikke er godkendt andre lægemidler mod CTEPH.
It also noted that no other medicines have been authorised for CTEPH.
Udvalget bemærkede desuden, at der var begrænsede behandlingsmuligheder for patienter med kronisk lymfatisk leukæmi, som ikke havde responderet på tidligere behandling.
The Committee also noted that patients with CLL who had not responded to previous treatment have limited treatment options.
Udvalget bemærkede desuden, at korttarmssyndrom er en alvorlig og invaliderende lidelse, som der kun findes begrænset lindrende behandling for.
The Committee also noted that short bowel syndrome is a serious and disabling condition for which only limited symptomatic treatment exists.
Udvalget bemærkede desuden, at påvisning af Atriplas gavnlige effekt primært er baseret på 48 ugers data fra en undersøgelse, hvor patienter med stabil suppression af hiv i hiv-kombinationsbehandling skiftede til Atripla.
The Committee also noted that the demonstration of Atripla’s benefit is based mainly on 48-week data from a study in patients with stable suppression of HIV on an HIV treatment combination who then switched to Atripla.
Udvalget bemærkede også risikoen for bivirkninger fra nyrerne og anbefalede, at nyrefunktionen vurderes nøje før påbegyndelse af behandlingen og overvåges under behandlingen.
The Committee also noted the risk of side effects affecting the kidneys, and recommended that kidney function should be carefully assessed before patients start taking Stribild and should be monitored during treatment.
Udvalget bemærkede også, at det vides, at tazobactam ikke er aktivt mod visse klasser af betalactamase- producerende arter, hvilket kan medføre resistensproblemer.
The Committee also noted that tazobactam is known not to be active against some classes of beta-lactamase that can cause problems of resistance.
Udvalget bemærkede også, at for patienter med homozygot, familiær sygdom er der et uopfyldt, klinisk behov, idet disse patienter er vanskelige at behandle og har en høj risiko for kardiovaskulære sygdomme.
The Committee also noted that for patients with homozygous familial disease there is an unmet clinical need, as these patients are difficult to treat and have a high risk of cardiovascular disease.
Udvalget bemærkede også, at sikkerhedsprofilen for Imnovid blev betragtet som acceptabel for disse patienter, med bivirkninger der ligner dem fra andre lægemidler af denne type.
The Committee also noted that the safety profile of Imnovid was considered acceptable for these patients, with side effects similar to those of other medicines of this type.
Udvalget bemærkede, at alle undersøgelserne hos patienter med primær hyperkolesterolæmi og blandet dyslipidæmi, herunder patienter, der fik den maksimalt anbefalede dosis af statiner eller ikke tålte den, viste, at Praluent medførte en vigtig mindskelse af LDL-kolesterol, som er en kendt risikofaktor for hjerte-kar-sygdomme (kardiovaskulære sygdomme).
The Committee noted that across all studies in patients with primary hypercholesterolaemia and mixed dyslipidaemia, including patients on maximum recommended doses of statins or those intolerant to them, Praluent showed an important reduction in LDL-cholesterol levels, which is a known risk factor for cardiovascular (affecting the heart and blood vessels) disease.
Udvalget bemærkede, at Blincyto er til gavn for voksne i højrisikogruppen med Ph- B-precursor ALL, som har få behandlingsmuligheder og sædvanligvis har dårlige udsigter.
The Committee noted that Blincyto is beneficial for high risk adults with Ph- B-precursor ALL who have few therapeutic options and who generally have a poor prognosis.
Udvalget bemærkede, at der aktuelt ikke var nogen andre lægemidler, der var godkendt til at behandle symptomerne på MS, og at de alvorlige bivirkninger ved Fampyra var sjældne.
The Committee noted that no other medicine was currently approved to treat the symptoms of MS and that the serious side effects with Fampyra were rare.
Udvalget bemærkede, at der ikke havde deltaget patienter på under fem år i hovedundersøgelsen for Naglazyme, men at det imidlertid er vigtigt at behandle dem, hvis de lider af en svær form for MPS VI.
The Committee noted that, although patients under five years of age were not included in the main study of Naglazyme, it is important that they are treated if they have a severe form of MPS VI.
Udvalget bemærkede, at der var meget få alternative behandlinger for disse patienter.
The Committee noted that there were very few alternative treatments for those patients.
Udvalget bemærkede, at en beredskabsvaccine til børn og unge i tilfælde af en influenzapandemi opfylder et væsentligt medicinsk behov.
The Committee noted that preparing for a potential flu pandemic in children and adolescents meets an important medical need.
Udvalget bemærkede, at Eurartesim overholder Verdenssundhedsorganisationens anbefalinger vedrørende behandling af P. falciparum- malaria ved at tilbyde en ny, alternativ artemisinin-kombinationsterapi bestående af to aktive stoffer, som virker på forskellige måder.
The Committee noted that Eurartesim meets World Health Organization recommendations for P. falciparum malaria treatment by offering a new alternative artemisinin combination therapy containing two active substances which work in different ways.
Udvalget bemærkede, at hypofosfatasi er en alvorlig, livstruende sygdom, som der ikke findes nogen godkendt behandling for.
The Committee noted that hypophosphatasia is a serious and life-threatening disease for which no treatment is authorised.
Udvalget bemærkede, at Imbruvica også var effektivt hos patienter med mantelcellelymfom, som ikke reagerede på den forudgående behandling, eller hos hvem sygdommen var kommet igen og en patientgruppe med dårlig udsigt for sygdomsforløbet og med kun få andre behandlingsmuligheder.
The Committee noted that Imbruvica was also effective in patients with mantle cell lymphoma that did not respond to or had come back after previous treatment, a group with poor prognosis and few other treatment options.
Udvalget bemærkede, at livskvaliteten øges ved behandling med Jakavi, men at lægemidlets virkninger mangler at blive vurderet hvad angår livsforlængende virkning og forsinkelse i sygdommens udvikling eller i indsætten af leukæmi.
The Committee noted that the quality of life of patients treated with Jakavi was improved but that the medicine’s effects had still to be evaluated in terms of extending the life of patients or delaying the progress of the disease or the onset of leukaemia.
Udvalget bemærkede, at på tværs af alle studier hos patienter med primær hypercholestererolæmi og blandet dyslipidæmi, herunder patienter på maksimale, anbefalede doser af statiner eller patienter, der ikke tålte dem, viste Repatha en væsentlig nedsættelse af LDL-cholesterolniveauerne, der er en kendt risikofaktor ved kardiovaskulære sygdomme.
The Committee noted that across all studies in patients with primary hypercholesterolaemia and mixed dyslipidaemia, including patients on maximum recommended doses of statins or those intolerant to them, Repatha showed an important reduction in LDL-cholesterol levels, which is a known risk factor for cardiovascular disease.
Udvalget besluttede derfor, at brugen af lægemidlet skulle være forbeholdt behandling af lungebetændelse erhvervet uden for hospital, behandling af bronkitis og sinusitis, når disse skyldtes bakterier, som er resistente over for antibiotika indeholdende beta-laktamer eller makrolider, og behandling af tonsillitis/pharyngitis, når disse antibiotika ikke kan anvendes.
Therefore, the Committee decided that its use should be reserved to the treatment of community- acquired pneumonia, to the treatment of bronchitis and sinusitis when caused by bacteria that are resistant to beta-lactam or macrolide antibiotics, and to tonsillitis/pharyngitis when these antibiotics cannot be used.
Udvalget besluttede derfor, at fordelene ved DuoPlavin opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse.
The Committee therefore decided that DuoPlavin’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget besluttede derfor, at fordelene ved Raptiva er større end risiciene til behandling af voksne patienter med moderat til svær kronisk plaque psoriasis, hos hvilke anden systemisk behandling, herunder ciclosporin, methotrexat og PUVA, enten ikke virker, er kontraindiceret eller ikke tåles.
Therefore, the Committee decided that Raptiva’s benefits are greater than its risks for the treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contra-indication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA.
Udvalget besluttede derfor, at fordelene ved Votrient opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
Therefore, the Committee decided that Votrient’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget besluttede derfor, at fordelene ved Wilzin opvejer risiciene ved behandling af Wilzins sygdom.
Therefore, the Committee decided that Wilzin’s benefits are greater than its risks for the treatment of Wilson’s disease.
Udvalget besluttede, at fordelene ved ACOMPLIA er større end risiciene ved anvendelse som supplement til diæt og motion til behandling af svært overvægtige patienter og overvægtige patienter med risikofaktorer såsom type 2-diabetes eller dyslipidæmi.
The Committee decided that ACOMPLIA’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.
Udvalget besluttede, at fordelene ved Angiox opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse.
It decided that Angiox’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget besluttede, at fordelene ved Azarga opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Azarga.
The Committee decided that Azarga’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget besluttede, at fordelene ved Busilvex opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Busilvex.
The Committee decided that Busilvex’s benefits are greater than its risks in these settings and recommended that Busilvex be given marketing authorisation.
Udvalget besluttede, at fordelene ved Competact opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Competact.
The Committee decided that Competact’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget besluttede, at fordelene ved Corlentor opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Corlentor.
The Committee decided that Corlentor’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget besluttede, at fordelene ved Diacomit opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Diacomit.
It decided that Diacomit’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget besluttede, at fordelene ved Elaprase opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Elaprase.
The Committee decided that Elaprase’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget besluttede, at fordelene ved Evista er større end risiciene ved behandling og forebyggelse af osteoporose hos postmenopausale kvinder.
The Committee decided that Evista’s benefits are greater than its risks for the treatment and prevention of osteoporosis in postmenopausal women.
Udvalget besluttede, at fordelene ved Evoltra opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse.
The Committee decided that Evoltra’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget besluttede, at fordelene ved Gilenya opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Gilenya.
The Committee decided that Gilenya’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget besluttede, at fordelene ved Humenza opvejer risiciene, når det anvendes til forebyggende behandling mod influenza under den officielt erklærede H1N1-pandemi, og anbefalede udstedelse af markedsføringstilladelse for Humenza.
The Committee decided that Humenza’s benefits are greater than its risks for the prophylaxis of influenza in the officially declared H1N1 pandemic situation and recommended that it be given marketing authorisation.
Udvalget besluttede, at fordelene ved Optruma er større end risiciene ved behandling og forebyggelse af osteoporose hos postmenopausale kvinder.
The Committee decided that Optruma’s benefits are greater than its risks for the treatment and prevention of osteoporosis in postmenopausal women.
Udvalget besluttede, at fordelene ved Orphacol overstiger risiciene på grundlag af beviser fra den videnskabelige litteratur, og anbefalede udstedelse af markedsføringstilladelse for Orphacol.
It decided that based on the evidence from the scientific literature Orphacol’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget besluttede, at fordelene ved Procoralan opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Procoralan.
The Committee decided that Procoralan’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget besluttede, at fordelene ved Ranexa er større end risiciene som tillægsbehandling af symptomerne hos patienter med stabil angina pectoris, som er utilstrækkeligt kontrolleret med, eller som ikke tolerer de lægemidler, der anvendes i førstevalgsbehandling (såsom betablokkere og/eller calciumantagonister).
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).
Udvalget besluttede, at fordelene ved ZIMULTI er større end risiciene ved anvendelse som supplement til diæt og motion til behandling af svært overvægtige patienter og overvægtige patienter med risikofaktorer såsom type 2-diabetes eller dyslipidæmi.
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.
Udvalget betragtede også det, at Zytiga indtages via munden, som en yderligere fordel.
The Committee also considered the fact that Zytiga is given by mouth to be a further advantage.
Udvalget fandt derfor, at fordelene ved Fareston opvejer risiciene til førstevalgsbehandling af hormonafhængig metastatisk brystkræft hos kvinder efter overgangsalderen.
Therefore, the Committee decided that Fareston’s benefits are greater than its risks for the first line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients.
Udvalget fandt derfor, at fordelene ved Spedra overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse til anvendelse i EU.
The Committee therefore considered that Spedra’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Udvalget fandt desuden, at en delvis gunstig virkning kunne være til fordel for sådanne patienter.
It also considered that a partial response may be of benefit in these patients.
Udvalget fandt det påvist, at Mekinist uden tillægsbehandling eller i kombination med dabrafenib havde en klinisk betydningsfuld fordel for patienter med melanom med BRAF V600-mutationen.
The Committee considered that Mekinist when used alone or in combination with dabrafenib had shown a clinically relevant benefit in patients whose melanoma had a BRAF V600 mutation.
Udvalget fandt dog, at fordelene ved Ozurdex opvejede risiciene hos patienter, der havde en kunstig linse i det berørte øje, eller som tidligere ikke havde haft gavn af andre behandlinger uden binyrebarkhormon eller havde været uegnede dertil.
However, in those with an artificial lens in the affected eye or who previously have not responded to or are unsuitable for other non-corticosteroid treatments, the benefits of Ozurdex were considered to outweigh the risks.
Udvalget fandt også, at de forliggende oplysninger støtter anvendelsen af Olysio i kombination med sofosbuvir.
The Committee also considered that the data available support the use of Olysio in combination with sofosbuvir.
Udvalget fandt også, at Sovaldi ved anvendelse i kombination med ribavirin inden levertransplantation kan forebygge reinfektion af leveren, som uden behandling næsten er uundgåelig og medfører dårlig prognose.
The Committee also considered that, if given before a liver transplant, Sovaldi in combination with ribavirin can prevent re-infection of the liver, which in the absence of treatment occurs nearly always and results in a poor prognosis.
Udvalget fandt, at Bosulif var påvist at være effektivt til at kontrollere CML hos disse patienter, og at det trods betydelige bivirkninger havde en acceptabel sikkerhedsprofil som sidste behandlingsmulighed hos disse patienter.
The Committee considered that Bosulif had been shown to be effective at controlling CML in these patients and, although it had important side effects, its safety profile was acceptable as a last treatment option in these patients.
Udvalget fandt, at det på overbevisende måde var påvist, at Tafinlar var en klinisk relevant fordel for patienter, hvis melanom havde en BRAF V600-mutation og havde bredt sig eller ikke kunne fjernes kirurgisk.
The Committee considered that Tafinlar (alone or in combination with trametinib) had shown a clinically relevant benefit in patients whose melanoma had a BRAF V600 mutation and had spread or was not surgically removable.
Udvalget fandt, at det var blevet påvist, at Perjeta var til fordel for patienter med metastatisk kræft ved at forlænge den tid, patienterne levede uden forværring af sygdommen, og hvor længe de overlevede.
The Committee considered that Perjeta has been shown to benefit patients with metastatic cancer by extending the amount of time patients lived without their disease getting worse as well as how long they lived.
Udvalget fandt, at fordelene ved Adenuric er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Adenuric.
The Committee decided that Adenuric’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget fandt, at fordelene ved ATryn opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The Committee decided that ATryn’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget fandt, at fordelene ved Deltyba var påvist for patienter med multiresistent lungetuberkulose.
The Committee considered that the benefits of Deltyba had been shown for patients with multi-drug resistant tuberculosis affecting the lung.
Udvalget fandt, at fordelene ved DepoCyte opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The Committee decided that DepoCyte’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget fandt, at fordelene ved Dukoral opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Dukoral.
The Committee decided that Dukoral’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget fandt, at fordelene ved Gliolan opvejer risiciene til synliggørelse af ondartet væv ved operation for ondartet gliom.
The Committee decided that Gliolan’s benefits are greater than its risks for the visualisation of malignant tissue during surgery for malignant glioma.
Udvalget fandt, at fordelene ved Invanz er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The Committee decided that Invanz’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget fandt, at fordelene ved Mircera opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The Committee decided that Mircera’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget fandt, at fordelene ved Orencia opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The Committee decided that Orencia’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget fandt, at fordelene ved Posaconazole SP er større end risiciene ved behandling af invasiv aspergillose, fusariose, coccidioidomykose, chromoblastermykose og mycetom hos patienter, der ikke tåler andre svampemidler, eller hos hvem der ikke er indtrådt bedring efter 7 dages behandling.
The Committee decided that Posaconazole SP’s benefits are greater than its risks for treatment of invasive aspergillosis, fusariosis, coccidioidomycosis, chromoblastomycosis and mycetoma in patients who cannot tolerate other antifungal drugs or have not improved after at least 7 days of treatment.