natgillin/translations-raw huggingface dataset:
CHMP besluttede, at fordelene ved Zonegran opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Zonegran.
The CHMP decided that Zonegran’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP besluttede, at fordelene ved Zostavax opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The CHMP decided that Zostavax’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP besluttede, at fordelene ved Zutectra opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Zutectra.
The CHMP decided that Zutectra’s benefits are greater than its risks and recommended that Zutectra be given marketing authorisation.
CHMP besluttede, at fordelene ved Zyprexa opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The CHMP decided that Zyprexa’s benefits are greater than its risks and recommended that Zyprexa be given marketing authorisation.
CHMP besluttede, at fordelene ved Zyprexa Velotab opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The CHMP decided that Zyprexa Velotab’s benefits are greater than its risks and recommended that Zyprexa Velotab be given marketing authorisation.
CHMP besluttede, at indehaveren af markedsføringstilladelsen bør fortsætte med at indsende 1-årlige PSUR’er.
The CHMP decided that the MAH should continue to submit 1-yearly PSURs.
CHMP er af den opfattelse, at Vantobra ikke svarer til allerede godkendte lægemidler til sjældne sygdomme, jf. artikel 3 i Kommissionens forordning (EF) nr.
The CHMP is of the opinion that Vantobra is similar to authorised orphan medicinal product(s) within the meaning of Article 3 of Commission Regulation (EC) No.
CHMP er den opfattelse, at i henhold til artikel 8 i forordning (EF) nr.
The CHMP is of the opinion that pursuant to Article 8 of Regulation (EC) No.
CHMP er enig i de videnskabelige konklusioner draget af PRAC.
The CHMP agrees with the scientific conclusions made by the PRAC.
CHMP er enig i de videnskabelige konklusioner fra PRAC.
The CHMP agrees with the scientific conclusions made by the PRAC.
CHMP er enig i de videnskabelige konklusioner, der er fremsat af PRAC.
The CHMP agrees with the scientific conclusions made by the PRAC.
CHMP er enig i denne videnskabelige konklusion foretaget af PRAC.
The CHMP agrees with the scientific conclusions made by the PRAC.
CHMP er enig i PRACs videnskabelige konklusion.
The CHMP agrees with the scientific conclusions made by the PRAC.
CHMP er enig i PRAC’s videnskabelige konklusioner.
The CHMP agrees with the scientific conclusions made by the PRAC.
CHMP er enig med de videnskabelige konklusioner fra PRAC.
The CHMP agrees with the scientific conclusions made by the PRAC.
CHMP er enig med de videnskabelige konklusioner, som PRAC.
The CHMP agrees with the scientific conclusions made by the PRAC.
CHMP er enig med PRAC’s videnskabelige konklusioner.
The CHMP agrees with the scientific conclusions made by the PRAC.
CHMP er enige i de videnskabelige konklusioner givet af PRAC.
The CHMP agrees with the scientific conclusions made by the PRAC.
CHMP er enige med PRAC’s videnskabelige konklussioner og anbefaler som følge heraf ændringer til SmPC og indlægsseddel.
The CHMP agrees with the scientific conclusions made by the PRAC and recommended changes to the SmPC and package leaflet accordingly.
CHMP fandt derfor, at fordelene er større end risiciene, ligesom for Aclasta.
Therefore, the CHMP’s view was that, as for Aclasta, the benefit outweighs the identified risk.
CHMP fandt derfor, at fordelene er større end risiciene, ligesom for de andre former af tacrolimus.
Therefore, the CHMP’s view was that, as for other authorised forms of tacrolimus, the benefit outweighs the identified risk.
CHMP fandt derfor, at fordelene er større end risiciene, ligesom for Exelon.
Therefore, the CHMP’s view was that, as for Exelon, the benefit outweighs the identified risk.
CHMP fandt derfor, at fordelene er større end risiciene, ligesom for Glivec.
Therefore, the CHMP’s view was that, as for Glivec, the benefit outweighs the identified risk.
CHMP fandt derfor, at fordelene er større end risiciene, ligesom for Remicade.
Therefore, the CHMP’s view was that, as for Remicade, the benefit outweighs the identified risks.
CHMP fandt derfor, at fordelene er større end risiciene, ligesom for Taxotere.
Therefore, the CHMP’s view was that, as for Taxotere, the benefit outweighs the identified risk.
CHMP fandt derfor, at fordelene er større end risiciene, ligesom for Xeloda.
Therefore, the CHMP’s view was that, as for Xeloda, the benefit outweighs the identified risk.
CHMP fandt derfor, at fordelene er større end risiciene, ligesom for Zometa.
Therefore, the CHMP’s view was that, as for Zometa, the benefit outweighs the identified risk.
CHMP fandt derfor, at fordelene opvejer risiciene, ligesom for Neupogen.
Therefore, the CHMP’s view was that, as for Neupogen, the benefit outweighs the identified risks.
CHMP fandt derfor, at fordelene ved Bemfola ligesom ved GONAL-f er større end dets risici.
Therefore, the CHMP’s view was that, as for GONAL-f, the benefits of Bemfola outweigh the identified risks.
CHMP fandt derfor, at fordelene ved Ovaleap ligesom ved GONAL-f opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
Therefore, the CHMP’s view was that, as for GONAL-f, Ovaleap’s benefits are greater than its risks and recommended that it be approved for use in the EU.
CHMP fandt også, at Plegridy var til større fordel for patienterne, når de fik det hver anden uge i stedet for de mindre hyppige injektioner, der blev testet i undersøgelsen.
Also, the CHMP considered Plegridy to be of greater benefit to patients when given every two weeks as compared to less frequent injections tested in the study.
CHMP fandt, at Adempas gav væsentlig bedring i fysisk kapacitet hos patienter med CTEPH eller PAH.
The CHMP considered that Adempas led to significant improvements in exercise capacity in patients with CTEPH or PAH.
CHMP fandt, at behandling med Harvoni med eller uden ribavirin er til stor gavn for mange patienter med hepatitis C-virus, herunder dem, der har fået en levertransplantation og/eller som har kompenseret cirrose.
The CHMP considered that treatment with Harvoni, with or without ribavirin, is of high benefit to many patients with hepatitis C virus, including those who have had a liver transplant and/or who have compensated cirrhosis.
CHMP fandt, at behandling med Sevelamer carbonate Zentiva har gavnlig virkning ved at sænke blodets fosfatindhold uden at give større sikkerhedsmæssige problemer.
The CHMP considered that treatment with Sevelamer carbonate Zentiva has a beneficial effect in lowering blood phosphate levels without major safety concerns.
CHMP fandt, at Benlysta brugt som tillægsbehandling nedbragte sygdomsaktiviteten ved SLE uden nogen alvorlig risiko for patienten.
The CHMP considered that Benlysta, used as an add-on treatment, reduced disease activity in SLE without serious risk to the patient.
CHMP fandt, at Defitelio er påvist at forbedre overlevelsen hos patienter med svær VOD.
The CHMP considered that Defitelio had been shown to improve survival in patients with severe VOD.
CHMP fandt, at der er behov for en ny effektiv behandling af knoglelidelser ved fremskreden kræft, særlig til patienter med nyreproblemer, da de behandlingsmuligheder, der findes i øjeblikket, kan være giftige for nyrerne.
The CHMP noted that there is a need for a new effective treatment for bone disease in advanced cancer, particularly for patients with kidney problems since currently available treatments can be toxic for the kidneys.
CHMP fandt, at der ikke er væsentlige sikkerhedsmæssige betænkeligheder vedrørende mulig giftig virkning af kobber, da Cuprymina anvendes i meget lave doser.
The CHMP considered that there are no major safety concerns with regard to potential copper toxicity, since Cuprymina is used at very low doses.
CHMP fandt, at dette ville være en ekstra fordel, når det blev anvendt som supplement til andre lægemidler mod HER2-positiv kræft, navnlig trastuzumab.
It considered that this would provide an additional benefit when added to other medicines for HER2-positive cancer, notably trastuzumab.
CHMP fandt, at Ebymect er effektivt til at regulere blodsukkeret; det giver desuden vægttab, hvad der anses for en fordel hos sukkersygepatienter.
The CHMP considered Ebymect to be effective at controlling blood glucose levels; it also leads to weight loss, which is considered beneficial in patients with diabetes.
CHMP fandt, at fordelene ved Luveris opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse herfor.
The CHMP decided that Luveris’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP fandt, at fordelene ved Modigraf opvejer risiciene ved forebyggelse af afstødning af transplantat hos modtagere af nyre, lever eller hjerte og ved behandling af afstødning, som ikke var modtagelig for behandling med andre immunsuppressive lægemidler.
The CHMP decided that Modigraf’s benefits are greater than its risks for prophylaxis of transplant rejection in kidney, liver and heart recipients, and in the treatment of rejection resistant to treatment with other immunosuppressive medicinal products.
CHMP fandt, at fordelene ved Naglazyme opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse.
The CHMP decided that Naglazyme’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP fandt, at fordelene ved Onsenal opvejer risiciene, men bemærkede dog, at der ikke var blevet påvist nogen effekt af Onsenal på risikoen for at udvikle kræft i tarmene.
The CHMP decided that Onsenal’s benefits are greater than its risks but noted that no effect of Onsenal on the risk of developing cancer of the intestine had been shown.
CHMP fandt, at fordelene ved Præpandemisk Influenzavaccine (H5N1) (Split Virion, Inaktiveret, Adjuveret) GlaxoSmithKline Biologicals er større end risiciene til aktiv immunisering mod H5N1- undertypen af influenza A-virus.
The CHMP decided that the benefits of Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals are greater than its risks for active immunisation against H5N1 subtype of influenza A virus.
CHMP fandt, at Imbruvica havde vist sig effektivt til forsinkelse af videreudviklingen af kronisk lymfatisk leukæmi, både hos tidligere behandlede og hos tidligere ubehandlede patienter.
The CHMP considered that Imbruvica was shown to be effective at delaying progression of chronic lymphocytic leukaemia, both in patients previously untreated and in those who received previous treatment.
CHMP fandt, at Lynparza havde fordele af klinisk betydning i form af den forlængede overlevelse uden forværring af sygdommen hos kræftpatienter med en mutation af BRCA.
The CHMP considered that the benefit of Lynparza in prolonging survival of cancer patients with a BRCA mutation before their disease got worse was clinically relevant.
CHMP fandt, at lægemidlets virkning i form af nedsættelse af indholdet af LDL-kolesterol var en fordel for patienter med homozygot familiær hyperkolesterolæmi, som har et uopfyldt behandlingsbehov.
The CHMP considered that the medicine’s effect in reducing LDL cholesterol levels was a benefit for patients with homozygous familial hypercholesterolaemia, who have an unmet medical need.
CHMP fandt, at Opdivo overbevisende har vist at være til gavn for patienter med visse fremskredne kræftsygdomme (melanom, NSCLC eller nyrecellekarcinom) ved enten at forøge patienternes overlevelse eller den tid, de kunne leve, uden at deres sygdom forværredes.
The CHMP considered that Opdivo has been convincingly shown to benefit patients with certain advanced cancers (melanoma, NSCLC or renal cell carcinoma) by either increasing patients’ survival or the time they could live without their disease getting worse.
CHMP fandt, at Revestive var til fordel for voksne med korttarmssyndrom, da det væsentligt mindskede behovet for parenteral ernæring, og da denne virkning holdt sig efter et års behandling.
The CHMP considered that Revestive was beneficial for adults with short bowel syndrome as it significantly reduced the amount of parenteral nutrition needed, an effect which was maintained after a year of treatment.
CHMP fandt, at selv om de foreliggende undersøgelsesresultater ikke var endelige, viste de vedholdende fordele ved Keytruda hos patienter med fremskredent melanom.
The CHMP considered that available study results, although not final, consistently showed the benefits of Keytruda in patients with advanced melanoma.
CHMP fandt, at Sovaldi som supplement til standardbehandling er til fordel for patienterne.
The CHMP considered that adding Sovaldi to standard treatment is of benefit to patients.
CHMP fandt, at Zerbaxa var påvist at være effektivt til at helbrede infektioner hos de undersøgte patienter, men bemærkede, at der kun var indgået et begrænset antal patienter med komplicerede urinvejsinfektioner.
The CHMP considered that Zerbaxa had been shown to be effective at curing infections in the patients studied, but acknowledged that only a limited number of patients with complicated urinary tract infections had been included.
CHMP fremhævede det uopfyldte behov for behandling af autosomal dominant polycystisk nyresygdom og fandt, at Jinarc er effektivt til at bremse cystedannelsen og muligvis også forringelsen af nyrefunktionen hos patienter med denne tilstand, selv om yderligere langtidsdata afventes.
The CHMP noted the unmet need for treatments for autosomal dominant polycystic kidney disease and considered that Jinarc is effective at slowing down cyst formation and possibly the decline in kidney function in patients with the condition, although further long-term data are awaited.
CHMP gennemgik de oplysninger, som indehaveren af markedsføringstilladelsen havde indsendt, jf. artikel 14, stk.
Marketing Authorisation Holder and Manufacturer
CHMP konklu- derede derfor, at fordelene ved Bronchitol overstiger risiciene som tillæg til bedste standardbehandling af voksne patienter med cystisk fibrose, og anbefalede udstedelse af markedsføringstilladelse.
The CHMP therefore concluded that the benefits of Bronchitol in addition to best standard of care outweigh its risks for adult patients with cystic fibrosis and recommended that it be granted marketing authorisation.
CHMP konkluderede derfor, at fordelene ved Bydureon opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Bydureon.
The CHMP therefore decided that Bydureon’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede derfor, at fordelene ved Farydak opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The CHMP therefore decided that Farydak’s benefits are greater than its risks in this group and recommended that it be approved for use in the EU.
CHMP konkluderede derfor, at fordelene ved Lonquex overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The CHMP therefore concluded the benefits of Lonquex outweigh its risks and recommended that it be approved for use in the EU.
CHMP konkluderede derfor, at fordelene ved Nulojix er større end risiciene, og udvalget anbefalede udstedelse af markedsføringstilladelse for Nulojix.
The CHMP therefore concluded that Nulojix’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede derfor, at fordelene ved Odefsey opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The CHMP therefore decided that Odefsey’s benefits are greater than its risks and recommended that it be approved for use in the EU.
CHMP konkluderede derfor, at fordelene ved Pantecta Control er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Pantecta Control.
The CHMP therefore decided that Pantecta Control’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede derfor, at fordelene ved Pantoloc Control er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Pantoloc Control.
The CHMP therefore decided that Pantoloc Control’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede derfor, at fordelene ved Pantozol Control er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Pantozol Control.
The CHMP therefore decided that Pantozol Control’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede derfor, at fordelene ved Simbrinza opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The CHMP therefore concluded that Simbrinza’s benefits are greater than its risks and recommended that it be approved for use in the EU.
CHMP konkluderede derfor, at fordelene ved Somac Control er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Somac Control.
The CHMP therefore decided that Somac Control’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede derfor, at fordelene ved Yervoy opvejer risiciene, og udvalget anbefalede udstedelse af markedsføringstilladelse for Yervoy.
The CHMP therefore decided that Yervoy’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede derfor, at fordelene ved Zytiga var større end risiciene, og udvalget anbefalede udstedelse af markedsføringstilladelse for Zytiga.
Therefore, the CHMP concluded that the benefits of Zytiga were greater than its risks, and recommended it be granted marketing authorisation.
CHMP konkluderede derfor, fordelene ved Firmagon er større end risiciene ved behandling af voksne mandlige patienter med fremskreden hormonafhængig prostatakræft.
Therefore, the CHMP decided that Firmagon’s benefits are greater than its risks for the treatment of adult male patients with advanced hormone-dependent prostate cancer.
CHMP konkluderede endvidere, at forsinkelsen på syv måneder i udviklingen af sygdommen hos patienter med neuroendokrine tumorer med oprindelse i lungerne eller tarmen var klinisk relevant, på trods af de kendte bivirkninger ved Afinitor.
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.
CHMP konkluderede endvidere, at Xolair (300 mg) viste sig at lindre symptomerne på kronisk spontan nældefeber betydeligt, når det blev anvendt som tillægsbehandling til patientens eksisterende behandling, men bemærkede, at undersøgelsesdataene vedrørende langvarig anvendelse ud over seks måneder var begrænsede.
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.
CHMP konkluderede ligeledes, at der ikke var væsentlige sikkerhedsproblemer forbundet med Bretaris Genuair, hvis bivirkninger er reversible og ligner de bivirkninger, der er forbundet med andre antikolinerge bronkodilatorer.
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.
CHMP konkluderede ligeledes, at der ikke var væsentlige sikkerhedsproblemer forbundet med Eklira Genuair, hvis bivirkninger er reversible og ligner de bivirkninger, der er forbundet med andre antikolinerge bronkodilatorer.
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.
CHMP konkluderede ligeledes, at Pradaxa kunne sammenlignes med warfarin, når det gælder om at nedsætte risikoen for slagtilfælde hos patienter med atrieflimren uden at øge risikoen for større blødninger.
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.
CHMP konkluderede, at behandling med Xalkori har en gavnlig virkning på, hvor længe patienter overlever med ALK-positiv ikke-småcellet lungekræft, uden at sygdommen forværres, uanset om de tidligere var blevet behandlet.
The CHMP concluded that treatment with Xalkori has a beneficial effect on the length of time the patients with ALK-positive NSCLC lived without the disease getting worse, irrespective of whether they were previously treated.
CHMP konkluderede, at betydeligt flere patienter var uden tegn på infektion, når de fik Olysio som tillægsbehandling til peginterferon alfa og ribavirin, og at dette gælder både tidligere ubehandlede og tidligere behandlede patienter.
The CHMP concluded that, in both previously untreated patients and patients who had already been treated, adding Olysio to treatment with peginterferon alfa and ribavirin considerably increased the number of patients showing no sign of infection.
CHMP konkluderede, at Capecitabine Medac 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, Capecitabine Medac has been shown to have comparable quality and to be bioequivalent to Xeloda.
CHMP konkluderede, at Capecitabine Teva 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, Capecitabine Teva has been shown to have comparable quality and to be bioequivalent to Xeloda.
CHMP konkluderede, at Caprelsa har vist sig at være effektiv i behandlingen af medullær thyreoideacancer, selv om der var usikkerhed omkring graden af effektivitet hos patienter, hvis RET- mutationsstatus er negativ eller ukendt.
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.
CHMP konkluderede, at Carbaglu var effektivt til at reducere ammoniumsniveauerne i blodet til normale niveauer, og besluttede, at fordelene ved Carbaglu opvejer risiciene.
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.
CHMP konkluderede, at Cetrotide er et sikkert og effektivt alternativ til eksisterende behandlinger til forebyggelse af præmatur ægløsning.
The CHMP concluded that Cetrotide is a safe and effective alternative to existing treatments for the prevention of premature ovulation.
CHMP konkluderede, at Corlentor viste sig at være effektivt til behandling af kronisk angina og havde en acceptabel sikkerhedsprofil, som gjorde, at det kunne bruges som en alternativ behandling hos patienter, der ikke kan tage betablokkere, eller hvis sygdom ikke kan kontrolleres med disse.
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.
CHMP konkluderede, at de langvarige erfaringer med det aktive stof, methylthioniniumchlorid, viser, at det er effektivt til behandling af methæmoglobinæmi.
The Committee concluded the long experience with the active substance, methylthioninium chloride, shows that it is effective in treating methaemoglobinaemia.