natgillin/translations-raw huggingface dataset:
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Zenapax er større end risiciene ved forebyggelse af akut organafstødning ved de novo allogen nyretransplantation, når Zenapax anvendes sammen med en immunosuppressiv behandlingsmetode, herunder ciclosporin og kortikosteroider hos patienter, der ikke er kraftigt immuniserede.
The Committee for Medicinal Products for Human Use (CHMP) decided that Zenapax’s benefits are greater than its risks for the prophylaxis of acute organ rejection in de novo allogenic renal transplantation, used concomitantly with an immunosuppressive regimen, including ciclosporin and corticosteroids in patients who are not highly immunised.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Zerene opvejer risiciene ved behandling af patienter, der lider af søvnløshed og som har besvær med at falde i søvn, hvis lidelsen er alvorlig, invaliderende eller udsætter personen for ekstrem lidelse.
The Committee for Medicinal Products for Human Use (CHMP) decided that Zerene’s benefits are greater than its risks for the treatment of patients with insomnia who have difficulty falling asleep, when the disorder is severe, disabling or subjecting the individual to extreme distress.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at IONSYS udviser potentielle fordele i forhold til systemer, hvor det smertelindrende stof indgives gennem en vene: det er ikke- invasivt, kræver ikke brug af kanyle, det er forprogrammeret og kan aktiveres af patienten.
The Committee for Medicinal Products for Human Use (CHMP) concluded that IONSYS offers potential benefits compared to systems where the pain relief is given via a vein: it is non-invasive, needle-free and pre-programmed, and it can be activated by the patient.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at LeukoScan’s fordele er større end risiciene ved bestemmelse af lokalisering og udstrækning af infektion/betændelse i knogler hos patienter med formodet osteomyelitis, herunder patienter med diabetiske fodsår.
The Committee for Medicinal products for Human Use (CHMP) decided that LeukoScan’s benefits are greater than its risks for determining the location and extent of infection/inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic foot ulcers.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at lægemidlet, selvom der kun foreligger få systematiske undersøgelser med Cystadane, er et værdifuldt supplement til de eksisterende midler mod homocystinuri, f.eks. vitamintilskud og særlig diæt.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, although there were few systematic studies of Cystadane, the medicine is useful when added to existing treatments for homocystinuria, such as vitamin supplementation and using a special diet.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Neofordex har vist sig at være af en kvalitet, der kan sammenlignes med Dectancyl, og brugen af højdosis-dexamethason ved multipelt myelom er anerkendt.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Neofordex has been shown to have comparable quality to Dectancyl and the use of high-dose dexamethasone in multiple meyloma is well established.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Nimvastid i overensstemmelse med EU’s krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Exelon.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Nimvastid has been shown to have comparable quality and to be bioequivalent to Exelon.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Olanzapin Mylan i overensstemmelse med EU’s krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Zyprexa.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Olanzapine Mylan has been shown to have comparable quality and to be bioequivalent to Zyprexa.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Olanzapin Teva i overensstemmelse med EU’s krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Zyprexa og Zyprexa Velotab.
The CHMP concluded that, in accordance with EU requirements, Olanzapine Teva has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Omnitrope i henhold til EU- kravene er påvist at have en kvalitet, sikkerhed og virkning, der er sammenlignelig med Genotropins.
The Committee for Medicinal products for Human Use (CHMP) considered that, in accordance with EU requirements, Omnitrope has been shown to have a comparable quality, safety and efficacy profile to Genotropin.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Pramipexol Teva i overensstemmelse med EU’s krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Sifrol.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pramipexole Teva has been shown to have comparable quality and to be bioequivalent to Sifrol.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Prometax har en beskeden effekt ved behandling af symptomerne på Alzheimers sygdom, selv om dette udmønter sig i en betydelig gavnlig effekt hos visse patienter.
The CHMP concluded that Prometax has a modest effectiveness in treating the symptoms of Alzheimer’s dementia, although this does reflect an important benefit in some patients.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Repaglinid Teva i overensstemmelse med EU’s krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med NovoNorm.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Repaglinide Teva has been shown to have comparable quality and to be bioequivalent to NovoNorm.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Ribavirin Teva i overensstemmelse med EU’s krav har vist sig at være 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 has been shown to have comparable quality and to be bioequivalent to Rebetol.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Rivastigmin Teva i overensstemmelse med EU’s krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Exelon.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Rivastigmine Teva has been shown to have comparable quality and to be bioequivalent to Exelon.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Topotecan Actavis i overensstemmelse med EU’s krav har vist sig at være af sammenlignelig med Hycamtin.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Topotecan Actavis has been shown to be comparable to Hycamtin.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Topotecan Teva i overensstemmelse med EU’s krav har vist sig at være af sammenlignelig med Hycamtin.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Topotecan Teva has been shown to be comparable to Hycamtin.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at virkningen af Rivastigmine 1 A Pharma på symptomerne på Alzheimers sygdom er beskeden, men at den hos nogle patienter er vigtig.
The CHMP concluded that Rivastigmine 1 A Pharma has a modest effectiveness in treating the symptoms of Alzheimer’s dementia, although this does reflect an important benefit in some patients.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at virkningen af Rivastigmine Hexal på symptomerne på Alzheimers sygdom er beskeden, men at den hos nogle patienter er vigtig.
The CHMP concluded that Rivastigmine Hexal has a modest effectiveness in treating the symptoms of Alzheimer’s dementia, although this does reflect an important benefit in some patients.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at virkningen af Rivastigmine Sandoz på symptomerne på Alzheimers sygdom er beskeden, men at den hos nogle patienter er vigtig.
The CHMP concluded that Rivastigmine Sandoz has a modest effectiveness in treating the symptoms of Alzheimer’s dementia, although this does reflect an important benefit in some patients.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Zalasta i overensstemmelse med EU’s krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Zyprexa og Zyprexa Velotab.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Zalasta has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab.
Udvalget for Humanmedicinske Lægemidler (CHMP) konstaterede, at fordelen ved Truvada til behandling af hiv-1-infektion kun er påvist hos patienter, der ikke tidligere har fået medicin mod hiv, men at den forenklede doseringsplan med en kombinationstablet, der tages én gang dagligt, kan gøre det lettere for patienterne at overholde behandlingen.
The Committee for Medicinal Products for Human Use (CHMP) noted that the benefit of Truvada for treating HIV-1 infection has only been shown in patients who have not taken HIV treatment before, but that the simplified dosing regimen offered by the combination tablet taken once a day may help patients to stick to their treatment.
Udvalget for Humanmedicinske Lægemidler (CHMP) konstaterede, at patienter med "stort behov" havde psoriasis i sværere grad, og at virkningen af Raptiva er relevant for sådanne patienter.
The Committee for Medicinal products for Human Use (CHMP) noted that psoriasis was more severe in ‘high-need’ patients, and that the effectiveness of Raptiva is relevant for these patients.
Udvalget for Humanmedicinske Lægemidler (CHMP) var af den opfattelse, at fordelene ved Apidra opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The Committee for Medicinal Products for Human Use (CHMP) decided that Apidra’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget for Humanmedicinske Lægemidler (CHMP) var af den opfattelse, at fordelene ved Lumigan opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse for Lumigan.
The Committee for Medicinal Products for Human Use (CHMP) decided that Lumigan’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget for Humanmedicinske Lægemidler (CHMP) var af den opfattelse, at fordelene ved Mozobil opvejer risiciene ved anvendelse i kombination med G-CSF til forøget mobilisering af hæmatopoietiske stamceller til det perifere blod til indsamling og efterfølgende autolog transplantation hos patienter med lymfon og multipelt myelom, hvis celler dårligt mobiliserer sig.
The Committee for Medicinal Products for Human Use (CHMP) decided that Mozobil’s benefits are greater than its risks for use in combination with G-CSF to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilise poorly.
Udvalget for Humanmedicinske Lægemidler (CHMP) var af den opfattelse, at fordelene ved Viraferon opvejer risiciene ved behandling af kronisk hepatitis B og C. Udvalget anbefalede udstedelse af markedsføringstilladelse for Viraferon.
The Committee for Medicinal Products for Human Use (CHMP) decided that Viraferon’s benefits are greater than its risks for the treatment of chronic hepatitis B and C. The Committee recommended that Viraferon be given marketing authorisation.
Udvalget for Humanmedicinske Lægemidler (CHMP) var af den opfattelse, at fordelene ved Xigris opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse.
The Committee for Medicinal Products for Human Use (CHMP) decided that Xigris’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede, at fordelene ved Aldara er større end risiciene til behandling af udvendige genitale og perianale vorter (condylomata acuminata), små basalcellekarcinomer og ikke-hyperkeratotiske, ikke-hypertrofiske aktiniske keratoser hos immunkompetente voksne patienter, når andre topiske behandlingsmuligheder er kontraindiceret eller mindre egnede.
The Committee for Medicinal Products for Human Use (CHMP) decided that Aldara’s benefits are greater than its risks for the treatment of external genital and perianal warts (condylomata acuminata), small basal cell carcinomas and nonhyperkeratotic, nonhypertrophic actinic keratoses in immunocompetent adult patients when other topical treatment options are contraindicated or less appropriate.
Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede, at fordelene ved MicardisPlus er større end risiciene ved behandling af essentiel hypertension hos patienter, hvis blodtryk ikke er tilstrækkeligt under kontrol med telmisartan alene.
The Committee for Medicinal Products for Human Use (CHMP) decided that MicardisPlus’s benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone.
Udvalget for Lægemidler til Dyr (CVMP) besluttede, at fordelene ved Panacur AquaSol opvejer risiciene, når det anvendes til de godkendte indikationer, og anbefalede udstedelse af en markedsføringstilladelse for Panacur AquaSol.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Panacur AquaSol exceed its risks for the approved indications and recommended that Panacur AquaSol be given a marketing authorisation.
Udvalget for Lægemidler til Dyr (CVMP) fandt, at fordelene ved Econor er større end risiciene til de godkendte indikationer.
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Econor exceed the risks for the approved indications.
Udvalget for Lægemidler til Dyr (CVMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Inflacam er af sammenlignelig kvalitet og er bioækvivalent med Metacam.
The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Inflacam has been shown to have comparable quality and to be bioequivalent to Metacam.
Udvalget for Lægemidler til Dyr (CVMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Novaquin er af sammenlignelig kvalitet og er bioækvivalent med Metacam.
The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Novaquin has been shown to have comparable quality and to be bioequivalent to Metacam.
Udvalget for Lægemidler til Dyr (CVMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Sedadex er af sammenlignelig kvalitet med Dexdomitor.
The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Sedadex has been shown to have comparable quality to Dexdomitor.
Udvalget for Lægemidler til Dyr (CVMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Sevohale er sammenlignelig med SevoFlo.
The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Sevohale has been shown to be comparable to SevoFlo.
Udvalget for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Broadline opvejer risiciene ved de godkendte anvendelser, og anbefalede udstedelse af en markedsføringstilladelse for Broadline.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Broadline exceed the risks for the approved indications and recommended that Broadline be given a marketing authorisation.
Udvalget for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Porcilis PCV M Hyo overstiger risiciene til den godkendte anvendelse, og anbefalede udstedelse af markedsføringstilladelse for Porcilis PCV M Hyo.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Porcilis PCV M Hyo exceed the risks for the approved indication and recommended that Porcilis PCV M Hyo be given a marketing authorisation.
Udvalget for Lægemidler til Mennesker (CHMP) bemærkede, at indsprøjtninger af paliperidon er effektivt til behandling af symptomerne på skizofreni.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) noted that paliperidone injections are effective in treating schizophrenia symptoms.
Udvalget for Lægemidler til Mennesker (CHMP) bemærkede, at virkningen af Nplate var blevet påvist hos patienter, som havde fået fjernet milten, og hos patienter, som stadig havde milten i behold.
The CHMP noted that the effectiveness of Nplate had been shown in patients who had had their spleen removed, as well as in patients who had not had their spleen removed.
Udvalget for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Emadine opvejer risiciene ved symptomatisk behandling af sæsonbetinget allergisk konjunktivitis.
The Committee for Medicinal Products for Human Use (CHMP) decided that Emadine’s benefits are greater than its risks for the symptomatic treatment of seasonal allergic conjunctivitis.
Udvalget for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Liprolog opvejer risiciene ved behandling af patienter med diabetes mellitus, som har behov for insulin til opretholdelse af normal glukosehomøostase og til initial stabilisering af diabetes mellitus.
The Committee for Medicinal products for Human Use (CHMP) decided that Liprolog’s benefits are greater than its risks for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis, and for the initial stabilisation of diabetes mellitus.
Udvalget for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Qutenza opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Qutenza.
The Committee for Medicinal Products for Human Use (CHMP) decided that Qutenza’s benefits are greater than its risks and recommended that Qutenza be given marketing authorisation.
Udvalget for Lægemidler til Mennesker (CHMP) fandt, at det i overensstemmelse med EU’s krav er påvist, at Levetiracetam Hospira er af sammenlignelig kvalitet og er bioækvivalent med Keppra.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Levetiracetam Hospira has been shown to have comparable quality and to be bioequivalent to Keppra.
Udvalget for Lægemidler til Mennesker (CHMP) fandt, at Envarsus i de godkendte doser er påvist at have en kvalitet, sikkerhed og virkning, der svarer til Advagraf og Prograf.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that the approved doses of Envarsus have been shown to have a comparable quality, safety and effectiveness to Advagraf and Prograf.
Udvalget for Lægemidler til Mennesker (CHMP) fandt, at generiske lægemidler svarende til Zoledronsyre Teva i overensstemmelse med EU-kravene er påvist at have en kvalitet svarende til Aclasta.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Zoledronic acid Teva Generics has been shown to be comparable to Aclasta.
Udvalget for Lægemidler til Mennesker (CHMP) fandt, at Imatinib Teva i overensstemmelse med EU- kravene er påvist at have en kvalitet svarende til Glivec og at være bioækvivalent med dette.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Imatinib Teva has been shown to have comparable quality and to be bioequivalent to Glivec.
Udvalget for Lægemidler til Mennesker (CHMP) fandt, at Inflectra i overensstemmelse med EU-kravene er påvist at have en kvalitet, sikkerhed og virkning, der svarer til Remicade.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Inflectra has been shown to have a comparable quality, safety and efficacy profile to Remicade.
Udvalget for Lægemidler til Mennesker (CHMP) fandt, at Remsima i overensstemmelse med EU- kravene er påvist at have en kvalitet, sikkerhed og virkning, der svarer til Remicade.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Remsima has been shown to have a comparable quality, safety and efficacy profile to Remicade.
Udvalget for Lægemidler til Mennesker (CHMP) fandt, at Rivastigmine 3M Health Care Ltd i overensstemmelse med EU-kravene er påvist at have en kvalitet svarende til Exelon og at være bioækvivalent med dette.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Rivastigmine 3M Health Care Ltd has been shown to have comparable quality and to be bioequivalent to Exelon.
Udvalget for Lægemidler til Mennesker (CHMP) fandt, at Tadalafil Mylan i overensstemmelse med EU- kravene er påvist at have en kvalitet svarende til Cialis og at være bioækvivalent med dette.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Tadalafil Mylan has been shown to have comparable quality and to be bioequivalent to Cialis.
Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at Aripiprazole Zentiva i overensstemmelse med EU's krav er af sammenlignelig kvalitet og er bioækvivalent med Abilify.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Mylan Pharma has been shown to have comparable quality and to be bioequivalent to Abilify.
Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at Aripiprazole Zentiva i overensstemmelse med EU's krav er af sammenlignelig kvalitet og er bioækvivalent med Abilify.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Zentiva has been shown to have comparable quality and to be bioequivalent to Abilify.
Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at BiResp Spiromax, 160/4,5 µg og 320/9 µg, er påvist at have en kvalitet svarende til Symbicort Turbohaler og at være bioækvivalent med dette.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that BiResp Spiromax 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be bioequivalent to the corresponding strengths of Symbicort Turbohaler.
Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at Bretaris Genuair viste sig at være effektivt til at lindre symptomerne ved KOL, og lægemidlets gavnlige virkninger blev fastholdt i op til et år.
The CHMP noted that Bretaris Genuair was shown to be effective at improving the symptoms of COPD, and its beneficial effects are maintained for up to a year.
Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at Clopidogrel ratiopharm i overensstemmelse med EU's krav er af sammenlignelig kvalitet og er bioækvivalent med Plavix.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel ratiopharm has been shown to have comparable quality and to be bioequivalent to Plavix.
Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det er påvist, at Budesonide/Formoterol Teva Pharma B.V., 160/4,5 µg og 320/9 µg, har en kvalitet som Symbicort Turbohaler og en virkning som de tilsvarende styrker af Symbicort Turbohaler.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Budesonide/Formoterol Teva Pharma B.V. 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be equivalent to the corresponding strengths of Symbicort Turbohaler.