natgillin/translations-raw huggingface dataset:
The Committee recommended that Loxicom be given a marketing authorisation.
Odbor je zato priporočil, da se zanj odobri dovoljenje za promet.
The Committee recommended that Mimpara be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Mimpara odobri dovoljenje za promet.
The Committee recommended that Mozobil be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Mozobil odobri dovoljenje za promet.
The Committee recommended that Nespo be given marketing authorisation.
Odbor je zato je priporočil, da se za zdravilo Nespo odobri dovoljenje za promet.
The Committee recommended that Nivestim be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Nivestim izda dovoljenje za promet.
The Committee recommended that Nordimet be approved for use in the EU.
Priporočil je, da se zdravilo Nordimet odobri za uporabo v EU.
The Committee recommended that NovoSeven be given marketing authorisation.
Zato je priporočil, da se zanj izda dovoljenje za promet.
The Committee recommended that Olazax be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Olazax izda dovoljenje za promet.
The Committee recommended that Oprymea be given marketing authorisation.
Priporočil je, da se zanj izda dovoljenje za promet.
The Committee recommended that Pioglitazone Accord be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Pioglitazone Accord odobri dovoljenje za promet.
The Committee recommended that Pioglitazone Actavis be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Pioglitazone Actavis Group odobri dovoljenje za promet.
The Committee recommended that PROCOMVAX be given marketing authorisation.
Odbor je priporočil, da se za zdravilo PROCOMVAX odobri dovoljenje za promet.
The Committee recommended that Remsima be approved for use in the EU.
Odbor je priporočil, da se zdravilo Remsima odobri za uporabo v EU.
The Committee recommended that Ribavirin BioPartners be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Ribavirin BioPartners odobri dovoljenje za promet.
The Committee recommended that Ribavirin Teva Pharma B.V. be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Ribavirin Teva Pharma B.V. odobri dovoljenje za promet.
The Committee recommended that Sevohale be approved for use in the EU.
Priporočil je, da se zdravilo Sevohale odobri za uporabo v EU.
The Committee recommended that Silapo be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Silapo izda dovoljenje za promet.
The Committee recommended that Stocrin be given marketing authorisation.
Priporočil je, da se za zdravilo Stocrin izda dovoljenje za promet.
The Committee recommended that Sustiva be given marketing authorisation.
Priporočil je, da se za zdravilo Sustiva izda dovoljenje za promet.
The Committee recommended that Tritanrix HepB be given marketing authorisation.
Odbor je priporočil, da se za cepivo Tritanrix HepB odobri dovoljenje za promet.
The Committee recommended that Vedrop be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Vedrop odobri dovoljenje za promet.
The Committee recommended that Voriconazole Hospira be approved for use in the EU.
Priporočil je, da se zdravilo Voriconazole Hospira odobri za uporabo v EU.
The Committee recommended that Xagrid be given marketing authorisation.
Priporočil je, da se zanj izda dovoljenje za promet.
The Committee recommended that Zerene be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Zerene odobri dovoljenje za promet.
The Committee recommended that Zoledronic acid Accord be approved for use in the EU.
Priporočil je, da se za zdravilo Zoledronic acid Accord izda dovoljenje za promet.
The Committee therefore concluded that Cholib’s benefits are greater than its risks and recommended that it be approved for use in the EU.
CHMP je zato zaključil, da so koristi zdravila Cholib večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The Committee therefore concluded that the benefits of Ameluz are greater than its risks and recommended that it be granted marketing authorisation.
Na podlagi navedenega je zaključil, da so koristi zdravila Ameluz večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee therefore concluded that the benefits of Daklinza outweigh its risks and recommended that it be approved for use in the EU.
Odbor je zato zaključil, da so koristi zdravila Daklinza večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The Committee therefore concluded that the benefits of Dexdor are greater than its risks and recommended that it be granted marketing authorisation.
Zato je CHMP zaključil, da so koristi zdravila Dexdor večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee therefore concluded that the benefits of Exviera outweigh its risks and recommended that it be approved for use in the EU.
Odbor je tako zaključil, da so koristi zdravila Exviera večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The Committee therefore concluded that the benefits of Komboglyze outweigh its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da koristi zdravila Komboglyze odtehtajo z njim povezana tveganja, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee therefore concluded that the benefits of Viekirax outweigh its risks and recommended that it be approved for use in the EU.
Odbor je tako zaključil, da so koristi zdravila Viekirax večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The Committee therefore concluded that the medicine’s benefits are greater than its risk and recommended that it be approved for use in the EU.
Odbor je zato zaključil, da so koristi zdravila večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The Committee therefore concluded that Zydelig’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor je tako zaključil, da so koristi zdravila Zydelig večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v 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.
Odbor je zato zaključil, da so koristi zdravila Spedra večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The Committee therefore decided that Buccolam’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je Odbor zaključil, da so koristi zdravila Buccolam večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee therefore decided that DuoPlavin’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zato zaključil, da so koristi zdravila DuoPlavin večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee therefore decided that HyQvia’s benefits are greater than its risks and recommended that it be approved for use in the EU.
CHMP je zato zaključil, da so koristi zdravila HyQvia večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The Committee therefore decided that Menveo’s benefits are greater than its risks in people who are at risk of exposure to N. meningitidis bacterium, and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Menveo pri ljudeh, pri katerih obstaja nevarnost izpostavljenosti bakteriji N. meningitidis, večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet
The Committee therefore decided that Pravafenix’s benefits are greater than its risks in this group of patients and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Pravafenix večje od z njim povezanih tveganj pri tej skupini bolnikov, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee therefore decided that Rasitrio’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zato zaključil, da so koristi zdravila Rasitrio večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee therefore decided that Trevicta’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zato zaključil, da so koristi zdravila Trevicta večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee therefore decided that Truberzi’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor je zato zaključil, da so koristi zdravila Truberzi večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The Committee took the view that, although the proportion of patients with Cushing’s disease who responded and whose cortisol levels in the urine normalised was small, Signifor could be of benefit in patients who have failed surgery or where surgery is not an option.
Odbor je menil, da bi zdravilo Signifor kljub majhnemu deležu bolnikov s Cushingovo boleznijo, ki so se odzvali na zdravljenje in katerih koncentracija kortizola v urinu se je normalizirala, lahko koristilo bolnikom, pri katerih kirurški poseg ni bil uspešen ali zanje ni primeren.
The common adverse reactions seen up to day 16 of the field trials are listed in the following table and compared to placebo:
Pogosti neželeni učinki, ki so jih opazili do dneva 16 preskušanj na terenu, so navedeni v spodnji tabeli in v primerjavi s placebom:
The common side effects (may affect up to 1 in 10 people) are: Feeling sick
Pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 bolnikov) so: siljenje na bruhanje
The company also carried out studies looking at the absorption of the orodispersible tablets and oral solution by the body.
Družba je izvedla tudi študije, v katerih so raziskali absorpcijo orodisperzibilnih tablet in peroralne raztopine v telesu.
The company also compared the combination tablet to separate tablets of lamivudine and zidovudine in 75 patients over 12 years of age who had not taken treatment for HIV infection before.
Družba je primerjala tudi kombinirano tableto z ločenima tabletama lamivudina in zidovudina pri 75 bolnikih, starejših od 12 let, ki pred tem zaradi okužbe z virusom HIV še niso bili zdravljeni.
The company also distributes information packs to provide healthcare workers, patients, and the male partners of female patients with information on the medicine’s side effects and the need to avoid pregnancy.
Prav tako bo zdravstvenim delavcem, bolnikom in partnerjem bolnic razdeljevala informativno gradivo, ki bo vsebovalo informacije o neželenih učinkih zdravila in nujnosti preprečitve zanositve.
The company also looked at the way the combined tablet was absorbed in the body in comparison with the separate medicines.
Družba je raziskala tudi, kako se kombinirane tablete v telesu absorbirajo v primerjavi z ločenimi zdravili.
The company also looked at the way the combined tablet was absorbed in the body in comparison with the separate tablets.
Družba je raziskala tudi, kako se kombinirane tablete absorbirajo v telesu v primerjavi z ločenimi tabletami.
The company also presented information from studies in 641 adults carried out using an earlier version of Humenza, containing a ‘bird flu’ strain H5N1.
Družba je predstavila tudi podatke iz študij s 641 odraslimi, ki so uporabljali prejšnjo obliko cepiva Humenza, ki je vsebovala sev „ptičje gripe“ H5N1.
The company also presented information on the use of Dukoral for the prevention of a severe type of traveller’s diarrhoea caused by a bacterium called ‘enterotoxigenic Escherichia coli’.
Družba je prav tako predstavila podatke o uporabi cepiva Dukoral za preprečevanje hude popotniške driske, ki jo povzroča bakterija, imenovana „enterotoksigena Escherichia coli“.
The company also presented information on the use of Vedrop in patients with cystic fibrosis, but withdrew its application for this disease during the evaluation of the medicine.
Družba je predstavila tudi podatke o uporabi zdravila Vedrop pri bolnikih s cistično fibrozo, vendar umaknila svojo vlogo za to bolezen med vrednotenjem zdravila.
The company also presented results from a series of studies conducted with vaccines of similar composition but including different serotypes from the ones in BTVPUR to provide supportive information that could be used to calculate the effectiveness of the vaccine.
Družba je predstavila tudi rezultate niza preskušanj, izvedenih s cepivi s podobno sestavo, ki pa so vključevali serotipe, drugačne od serotipov v cepivu BTVPUR, da bi pridobili nadaljnje zaključke o njegovi učinkovitosti.
The company also presented results from a series of trials conducted with vaccines of similar composition but including only one of the two serotypes of BTVPUR AlSap 2-4 in order to extrapolate further efficacy conclusions.
Družba je predstavila tudi rezultate niza preskušanj cepiv podobne sestave, ki vsebujejo le enega od dveh serotipov zdravila BTVPUR AlSap 2- 4, da bi tako pridobili nadaljnje zaključke o učinkovitosti.
The company also presented the results of 13 studies from the published literature, including one key study that compared the effect of Thyrogen and the effect of stopping replacement therapy in 394 patients who were followed up for around two and a half years.
Družba je predstavila tudi rezultate 13 študij iz objavljene literature, vključno z eno glavno študijo, v kateri so primerjali učinek zdravila Thyrogen in učinek prekinitve nadomestnega zdravljenja pri 394 bolnikih, ki so jih spremljali približno dve leti in pol.
The company also presented the results of a further study comparing Thymanax with sertraline (another antidepressant).
Družba je prav tako predstavila rezultate dodatne študije, v kateri so zdravilo Thymanax primerjali s sertralinom (drugim antidepresivom).
The company also presented the results of a further study comparing Valdoxan with sertraline (another antidepressant).
Družba je prav tako predstavila rezultate dodatne študije, v kateri so zdravilo Valdoxan primerjali s sertralinom (drugim antidepresivom).
The company also presented the results of a published study involving 1,002 patients, which compared the effects of Xeloda and 5-FU, taken in combination with platinum-containing medicines and epirubicin (another cancer medicine).
Družba je prav tako predstavila rezultate objavljene študije s 1 002 bolnikoma, v kateri so učinke zdravila Xeloda primerjali z učinki 5-FU, vzetima v kombinaciji z zdravili, ki vsebujejo platino, in epirubicinom (drugim zdravilom za zdravljenje raka).
The company also presented the results of a study comparing the effects of Abseamed injected under the skin with those of Eprex/Erypo in 114 cancer patients who were receiving chemotherapy.
Družba je predstavila tudi rezultate študije, v kateri so pri 114 bolnikih z rakom, ki so se zdravili s kemoterapijo, učinke injiciranja zdravila Abseamed v podkožje primerjali z zdravilom Eprex/Erypo.
The company also presented the results of a study comparing the effects of Binocrit injected under the skin with those of Eprex/Erypo in 114 cancer patients who were receiving chemotherapy.
Družba je predstavila tudi rezultate študije, v kateri so pri 114 bolnikih z rakom, ki so se zdravili s kemoterapijo, učinke injiciranja zdravila Binocrit v podkožje primerjali z zdravilom Eprex/Erypo.
The company also presented the results of a study in 32 healthy people looking at the levels of saxagliptin in the blood when saxagliptin is taken at 2.5 mg twice daily compared with when it is taken at 5 mg once daily.
Družba je predstavila tudi rezultate študije, v kateri je sodelovalo 32 zdravih oseb in s katero so proučevali raven saksagliptina v krvi pri njegovem jemanju v odmerku 2,5 mg dvakrat na dan v primerjavi z njegovim jemanjem v odmerku 5 mg enkrat na dan.
The company also presented the results of a study looking at the combination of Thalidomide Celgene and dexamethasone as ‘induction’ treatment for multiple myeloma for use before high-dose chemotherapy.
Družba je predstavila tudi rezultate študije, v kateri so proučevali kombinacijo zdravila Thalidomide Celgene in deksametazona kot „indukcijskega“ zdravljenja multiplega mieloma, namenjenega za uporabo pred kemoterapijo z visokimi odmerki.
The company also presented the results of a study showing that the oral suspension produced the same levels of the active substance in the blood as the tablets.
Družba je predstavila tudi izide študije, ki kažejo, da se pri jemanju peroralne suspenzije v krvi ustvarijo enake koncentracije zdravilne učinkovine kot pri jemanju tablet.
The company also presented the results of four studies from the scientific literature that looked at the effects of taking Crixivan in combination with ritonavir, including 20 patients who had already been taking Crixivan without ritonavir and 123 patients who had not taken HIV treatment before.
Družba je predstavila tudi rezultate štirih študij iz znanstvene literature, v katerih so proučevali učinke jemanja zdravila Crixivan v kombinaciji z ritonavirjem pri 20 bolnikih, ki so že jemali zdravilo Crixivan brez ritonavirja, in 123 bolnikih, ki predhodno zaradi okužbe z virusom HIV še niso bili zdravljeni.
The company also presented the results of studies from the published literature looking at Thyrogen’s effect when it was used with a thyroglobulin test, but without a radioactive iodine scan.
Družba je predstavila tudi rezultate študij iz objavljene literature, v katerih so proučevali učinek zdravila Thyrogen pri uporabi s tiroglobulinskim testom, vendar brez slikanja z radioaktivnim jodom.
The company also presented the results of studies in which patients received Emadine, levocabastine or placebo (a dummy treatment) before being subjected to an ‘allergen challenge’.
Družba je prav tako predstavila dognanja študij, v katerih so bolniki prejemali zdravilo Emadine, levokabastin ali placebo (zdravilo brez zdravilne učinkovine), preden so jih izpostavili alergenom.
The company also presented the results of two studies looking at the effects of Silapo injected under the skin: one involved 261 cancer patients receiving chemotherapy, and the other compared Silapo with Eprex/Erypo in 462 patients with anaemia caused by kidney problems.
Družba je predstavila tudi rezultate dveh študij, v katerih so ugotavljali učinke zdravila Silapo, injiciranega v podkožje: prva je vključevala 261 bolnikov z rakom, ki so prejemali kemoterapijo, v drugi pa so primerjali zdravilo Silapo z zdravilom Eprex/Erypo pri 462 bolnikih z anemijo kot posledico težav z ledvicami.
The company also provided data on the use of Cinryze in 91 patients to prevent attacks in patients undergoing a medical, surgical or dental procedure.
Družba je predložila tudi podatke o uporabi zdravila Cinryze pri 91 bolnikih za preprečevanje napadov pred zdravniškim, zobozdravstvenim ali kirurškim posegom.
The company also showed that Taxespira solution for infusion has comparable quality to that of Taxotere.
Taxespira20 mg/1 ml koncentrat za raztopino za infundiranje docetaksel
The company also used data from the scientific literature.
Družba je uporabila tudi podatke iz znanstvene literature.
The company applied for an authorisation to use Increlex in these children, but withdrew its application after the end of the medicine’s assessment, as this disease is not listed in the medicine’s ‘orphan’ designation.
Družba je zaprosila za dovoljenje za uporabo zdravila Increlex pri teh otrocih, vendar je ob zaključku ocenjevanja zdravila umaknila vlogo, saj ta bolezen ni navedena v določitvi zdravila kot zdravila sirote.
The company carried out a ‘bioequivalence’ study to show that 500 mg Capecitabine Medac produces the same levels of capecitabine in the blood as 500 mg Xeloda.
Izvedla je študije biološke enakovrednosti, s katerimi je dokazala, da 500-miligramski odmerek zdravila Cepecitabine Medac ustvarja enake ravni kapecitabina v krvi kot 500-miligramski odmerek zdravila Xeloda.
The company carried out a ‘bioequivalence’ study to show that 500 mg Ecansya produces the same levels of capecitabine in the blood as 500 mg of the reference medicine.
Izvedla je študije biološke enakovrednosti, s katerimi je dokazala, da 500-miligramski odmerek zdravila Ecansya dosega enake ravni kapecitabina v krvi kot 500-miligramski odmerek referenčnega zdravila.
The company carried out ‘bioequivalence’ studies to show that Aripiprazole Sandoz is bioequivalent to the reference medicine, Abilify.
Družba je izvedla študije biološke enakovrednosti, s katerimi je pokazala, da je zdravilo Aripiprazole Sandoz biološko enakovredno referenčnemu zdravilu Abilify.
The company carried out ‘bioequivalence’ studies to show that taking Corbilta produces the same levels of levodopa, carbidopa and entacapone in the blood as taking separate tablets containing entacapone and the combination of levodopa and carbidopa.
Družba je izvedla študije „biološke enakovrednosti“, da bi dokazala, da so ravni levodope, karbidope in entakapona v krvi pri jemanju zdravila Corbilta enake kot pri jemanju ločenih tablet, ki vsebujejo entakapon ter kombinacijo levodope in karbidope.
The company carried out ‘bioequivalence’ studies to show that taking Levodopa/Carbidopa/Entacapone Orion produces the same levels of levodopa, carbidopa and entecapone in the blood as taking separate tablets containing entacapone and the combination of levodopa and carbidopa.
Izvedla je tudi študije biološke enakovrednosti, da bi dokazala, da so ravni levodope, karbidope in entekapona v krvi pri jemanju zdravila Levodopa/Carbidopa/Entacapone Orion enake kot pri jemanju zdravilnih učinkovin v ločenih tabletah, od katerih ene vsebujejo entakapon, druge pa so kombinirane in vsebujejo levodopo in karbidopo.
The company carried out ‘bioequivalence’ studies to show that taking Stalevo produces the same levels of levodopa, carbidopa and entecapone in the blood as taking separate tablets containing entacapone and the combination of levodopa and carbidopa.
Izvedla je tudi bioekvivalenčne študije, da bi dokazala, da so ravni levodope, karbidope in entekapona v krvi pri jemanju zdravila Stalevo enake kot pri jemanju zdravilnih učinkovin v ločenih tabletah, od katerih ene vsebujejo entakapon, ter v kombiniranih tabletah, ki vsebujejo levodopo in karbidopo.
The company has also set up a pregnancy prevention programme in each Member State and will collect information on whether the medicine is used outside its approved indication.
Družba je v vsaki državi članici vzpostavila program preprečevanja nosečnosti in bo zbirala podatke o morebitni uporabi zdravila za neodobrene indikacije.
The company is also carrying out studies to determine the best dose to give to patients on a regular long- term basis.
Izvedli bodo tudi študije za določitev najustreznejšega odmerka za bolnike ob dolgoročni redni uporabi.
The company is also obliged to complete a study comparing the effects of Yervoy in doses of 3 and 10 mg per kg bodyweight in treating advanced melanoma.
Družba mora prav tako opraviti študijo za primerjavo 3- in 10-miligramskega odmerka zdravila Yervoy na kg telesne mase pri zdravljenju napredovalega melanoma.
The company marketing MabThera will provide doctors and patients using the medicine for rheumatoid arthritis with educational material on the risk of infection including of a rare severe infection known as progressive multifocal leukoencephalopathy (PML).
Družba, ki trži zdravilo MabThera, bo zdravnikom in bolnikom, ki uporabljajo zdravilo za revmatoidni artritis, priskrbela izobraževalni material o tveganju za okužbe, vključno s hudo redko okužbo, znano kot progresivna multifokalna levkoencefalopatija (PML).