natgillin/translations-raw huggingface dataset:
The CHMP agrees with the scientific conclusions made by the PRAC.
Odbor za zdravila za uporabo v humani medicini se strinja z znanstvenimi zaključki Odbora za oceno tveganja na področju farmakovigilance.
The CHMP agrees with the scientific conclusions made by the PRAC.
Skupina CHMP soglaša z znanstvenimi zaključki odbora PRAC.
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.
Poleg tega je bil mnenja, da je sedemmesečno podaljšanje časa brez napredovanja bolezni pri bolnikih z nevroendokrinim tumorjem pljučnega ali črevesnega izvora klinično pomembno, kljub znanim neželenim učnikom zdravila Afinitor.
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.
Poleg tega je menil, da je zdravilo Xolair (300 mg) bistveno izboljšalo simptome kronične spontane urtikarije, kadar se je uporabljalo kot dodatek k bolnikovemu obstoječemu zdravljenju, vendar so podatki iz študij o dolgoročni uporabi tega zdravila dlje kot šest mesecev omejeni.
The CHMP also considered that although Firdapse is marketed in most EU member states, the size of the patient population is limited, resulting in limitations of the overall exposure to the product.
Odbor CHMP nadalje meni, da čeprav je zdravilo Firdapse prisotno na trgu večine držav članic Evropske Unije, je populacija bolnikov omejena, kar vodi v omejitve glede celokupne izpostavljenosti zdravilu.
The CHMP also considered the seriousness of the disease and the lack of suitable alternative treatments for patients whose non-Hodgkin’s B cell lymphoma has come back or has not responded to other chemotherapy treatments.
Odbor CHMP je upošteval tudi resnost bolezni in pomanjkanje ustreznih nadomestnih zdravil za bolnike, pri katerih se je ne- Hodgkinov B-celični limfom ponovil ali se ni odzval na zdravljenje z drugimi kemoterapevtiki.
The CHMP also noted that giving the combination of dapagliflozin and metformin as a single tablet could provide an additional treatment option for patients with type 2 diabetes, and may improve adherence to treatment.
Prav tako je izpostavil, da je kombinacija dapagliflozina in metformina v eni tableti lahko dodatna možnost zdravljenja za bolnike s sladkorno boleznijo tipa 2, ki bi lahko prispevala k temu, da se bodo držali predpisanega zdravljenja.
The CHMP also noted that giving the combination of dolutegravir, abacavir and lamivudine as a single tablet is an additional treatment option for patients with HIV infection and without the HLA-B (type 5701) gene.
Odbor CHMP je prav tako izpostavil, da je dajanje kombinacije dolutegravirja, abakavirja in lamivudina v eni tableti dodatna možnost zdravljenja za bolnike, ki so okuženi z virusom HIV in nimajo gena HLA- B (tip 5701).
The CHMP also noted that more studies are needed to further confirm the benefit of Lynparza, its effect on overall survival and its long-term safety.
CHMP je tudi ugotovil, da je potrebnih več študij, ki bi nadalje potrdile koristi zdravila Lynparza, njegov učinek na celokupno preživetje in njegovo dolgoročno varnost.
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.
Menil je tudi, da je zdravilo Pradaxa dobro primerljivo z varfarinom pri zmanjševanju tveganja za kap pri bolnikih z atrijsko fibrilacijo, ne da bi se pri tem povečalo tveganje za večje krvavitve.
The CHMP also noted that the combination does not cause any unexpected side effects.
Ugotovil je tudi, da kombinacija ne povzroča nobenih nepričakovanih neželenih učinkov.
The CHMP also noted that the fact that the medicine is used once a day may help patients to comply with their treatment.
Prav tako je ugotovil, da se zaradi uporabe zdravila enkrat na dan bolniki lažje držijo zdravljenja.
The CHMP also noted that there were no major safety concerns with Anoro, with side effects being manageable, although the long-term safety data so far are limited.
CHMP je tudi ugotovil, da v zvezi z zdravilom Anoro ni večjih pomislekov glede varnosti, neželeni učinki pa so obvladljivi, čeprav so podatki o dolgoročni varnosti zdravila trenutno omejeni.
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.
Odbor je ugotovil tudi, da ni večjih pomislekov glede varnosti zdravila Bretaris Genuair, saj so njegovi neželeni učinki minljivi in podobni kot pri drugih antiholinergičnih bronhodilatatorjih.
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.
Odbor je ugotovil tudi, da ni večjih pomislekov glede varnosti zdravila Eklira Genuair, saj so njegovi neželeni učinki minljivi in podobni kot pri drugih antiholinergičnih bronhodilatatorjih.
The CHMP also noted that there were no major safety concerns with Incruse, with side effects being manageable and similar to other antimuscarinic bronchodilator medicines.
Ugotovil je tudi, da ni večjih pomislekov glede varnosti zdravila Incluse, saj so njegovi neželeni učinki obvladljivi in podobni kot pri drugih antimuskarinskih bronhodilatatorjih.
The CHMP also noted that there were no major safety concerns with Laventair, with side effects being manageable, although the long-term safety data so far are limited.
Prav tako je menil, da ni večjih pomislekov glede varnosti zdravila Laventair, saj so neželeni učinki obvladljivi, čeprav so dolgoročni podatki o tem še vedno skopi.
The CHMP also noted the lack of effective alternative treatments for patients who have already tried standard treatments.
Odbor je tudi ugotovil, da učinkovita nadomestna zdravljenja za bolnike, ki so že preizkusili standardno zdravljenje, niso na voljo.
The CHMP also noted, however, that there were limited data on the longer-term effects of the medicine and that further data should be provided by the company.
Opozoril je tudi, da so o dolgoročnih učinkih zdravila na voljo le omejeni podatki in da mora družba priskrbeti dodatne informacije.
The CHMP asked the company to conduct a study to compare the 3 and 10 mg per kg bodyweight doses directly.
CHMP je od družbe zahteval, da izvede študijo za neposredno primerjavo 3- in 10-miligramskega odmerka na kg telesne mase.
The CHMP concluded that Alimta’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Alimta večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP concluded that Anoro was shown to be effective at improving lung function and the symptoms of COPD when compared with placebo or the single components as well as with tiotropium.
Odbor CHMP je zaključil, da se je zdravilo Anoro izkazalo za učinkovito pri izboljševanju pljučne funkcije in simptomov KOPB v primerjavi s placebom, posameznima sestavinama in tiotropijem.
The CHMP concluded that Avaglim’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Avaglim večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP concluded that Baraclude’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Baraclude večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP concluded that benefits of Zinforo are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Zinforo večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
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 je zaključil, da je zdravilo Caprelsa učinkovito pri zdravljenju medularnega raka ščitnice, čeprav obstajajo negotovosti o obsegu koristi za bolnike z negativnim ali neznanim statusom mutacije RET.
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.
Odbor za zdravila za uporabo v humani medicini (CHMP) zaključil, da je zdravilo Carbaglu učinkovito pri zniževanju ravni amonijaka v krvi na običajno raven in odločil, da so njegove koristi večje od z njim povezanih tveganj.
The CHMP concluded that Cetrotide is a safe and effective alternative to existing treatments for the prevention of premature ovulation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da je zdravilo Cetrotide varna in učinkovita alternativa obstoječim zdravilom za preprečevanje prezgodnje ovulacije.
The CHMP concluded that Cholestagel’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Cholestagel večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
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 je zaključil, da je bilo za zdravilo Corlentor dokazano, da je dovolj učinkovito pri zdravljenju kronične angine pektoris in ima zadosten varnostni profil za nadomestno zdravljenje bolnikov, ki ne morejo jemati zaviralcev receptorjev beta oziroma katerih bolezen ni urejena z njimi.
The CHMP concluded that Daronrix’s benefits outweighed its risks, and that it had shown its suitability as a mock-up vaccine in preparation for a pandemic flu outbreak.
CHMP je zaključil, da prednosti zdravila Daronrix presegajo z njim povezana tveganja ter da se je zdravilo izkazalo kot ustrezno za modelno cepivo za primer izbruha pandemične gripe.
The CHMP concluded that Edistride was shown to be effective in lowering blood glucose levels in patients with type 2 diabetes, when given alone or in combination with other diabetes medicines with different mechanisms of action.
CHMP je zaključil, da je zdravilo Edistride učinkovito pri zmanjševanju ravni glukoze v krvi pri bolnikih s sladkorno boleznijo tipa 2, kadar se zdravilo uporablja kot samostojno zdravilo ali v kombinaciji z drugimi zdravili za sladkorno bolezen z drugačnimi mehanizmi delovanja.
The CHMP concluded that Exelon has a modest effectiveness in treating the symptoms of Alzheimer’s dementia, although this does reflect an important benefit in some patients.
CHMP je zaključil, da ima zdravilo Exelon pri zdravljenju simptomov Alzheimerjeve demence skromen učinek, čeprav ta pomeni pomembno korist za nekatere bolnike.
The CHMP concluded that Forxiga was shown to be effective in lowering blood glucose levels in patients with type 2 diabetes, when given alone or in combination with other antidiabetes medicines with different mechanisms of actions.
CHMP je zaključil, da je zdravilo Forxiga učinkovito pri zmanjševanju ravni glukoze v krvi pri bolnikih s sladkorno boleznijo tipa 2, kadar se zdravilo uporablja kot samostojno zdravilo ali v kombinaciji z drugimi zdravili za sladkorno bolezen z drugačnimi mehanizmi delovanja.
The CHMP concluded that Incruse was shown to be effective at improving the lung function and symptoms of COPD.
CHMP je zaključil, da je bilo dokazano, da zdravilo Incruse učinkovito izboljšuje delovanje pljuč in simptome KOPB.
The CHMP concluded that Jardiance was shown to be effective in lowering blood glucose levels in patients with type 2 diabetes, when given alone or in combination with other diabetes medicines with different mechanisms of action.
CHMP je zaključil, da se je zdravilo Jardiance pokazalo kot učinkovito pri zniževanju ravni glukoze v krvi pri bolnikih s sladkorno boleznijo tipa 2, kadar se zdravilo uporablja samostojno ali v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni z drugačnimi mehanizmi delovanja.
The CHMP concluded that Ketek’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Ketek večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP concluded that Komboglyze helps to reduce blood glucose levels in patients whose blood glucose levels are not adequately controlled by metformin alone, while the combination of saxagliptin and metformin in one tablet may help patients who already take both to follow their treatment correctly.
CHMP je zaključil, da zdravilo Komboglyze pomaga zniževati raven glukoze v krvi pri bolnikih, pri katerih raven glukoze ni zadostno uravnana samo z metforminom, pri čemer lahko kombinacija saksagliptina in metformina v eni tableti pomaga bolnikom, ki že jemljejo obe zdravilni učinkovini, da upoštevajo navodila za zdravljenje.
The CHMP concluded that Laventair was shown to be effective at improving lung function and the symptoms of COPD when compared with placebo or the single components as well as with tiotropium.
CHMP je zaključil, da se je zdravilo Laventair izkazalo kot učinkovito pri izboljšanju delovanja pljuč in simptomov KOPB v primerjavi s placebom ali posameznimi sestavinami oziroma tiotropijem.
The CHMP concluded that NovoEight has been shown to be effective at treating and preventing bleeding episodes, with effects similar to other factor VIII products.
Ugotovil je, da se je zdravilo NovoEight izkazalo za učinkovito pri zdravljenju in preprečevanju krvavitev ter da je imelo podobne učinke kot druga zdravila za nadomeščanje faktorja VIII.
The CHMP concluded that NutropinAq’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila NutropinAq večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP concluded that Nuwiq has been shown to be effective at treating and preventing the occurrence of bleeding in patients with haemophilia A. Nuwiq was also effective in preventing and treating bleeding in relation to surgery bleeding episodes, with effects similar to other factor VIII products.
Odbor CHMP je zaključil, da je bilo dokazano, da je zdravilo Nuwiq učinkovito pri zdravljenju in preprečevanju pojava krvavitev pri bolnikih s hemofilijo A. Prav tako je bilo zdravilo Nuwiq učinkovito pri preprečevanju in zdravljenju krvavitev, povezanih s kirurškimi posegi, pri čemer je imelo podobne učinke kot druga zdravila, ki vsebujejo faktor VIII.
The CHMP concluded that Orencia had a modest anti-inflammatory effect in rheumatoid arthritis and, in combination with methotrexate, led to a reduction in the worsening of joint damage and an improvement in physical function.
CHMP je zaključil, da ima zdravilo Orencia zmeren protivnetni učinek pri revmatoidnem artritisu in da je v kombinaciji z metotreksatom zmanjšalo poslabšanje poškodb sklepov in prispevalo k izboljšanju fizične funkcije.
The CHMP concluded that patients with aggressive non-Hodgkin’s B cell lymphoma had a better response to treatment with Pixuvri than other cancer treatments.
Odbor CHMP je zaključil, da so se bolniki z agresivnim ne-Hodgkinovim B-celičnim limfomom bolje odzvali na zdravilo Pixuvri kot na druga zdravila proti raku.
The CHMP concluded that Privigen’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Privigen večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP concluded that Procoralan 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 je zaključil, da je bilo za zdravilo Procoralan dokazano, da je dovolj učinkovito pri zdravljenju kronične angine pektoris in ima zadosten varnostni profil za nadomestno zdravljenje bolnikov, ki ne morejo jemati zaviralcev receptorjev beta oziroma katerih bolezen ni urejena z njimi.
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.
CHMP je zaključil, da ima zdravilo Prometax pri zdravljenju simptomov Alzheimerjeve demence skromen učinek, čeprav ta pomeni pomembno korist za nekatere bolnike.
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.
CHMP je zaključil, da ima zdravilo Rivastigmine 1 A Pharma pri zdravljenju simptomov Alzheimerjeve demence skromen učinek, čeprav ta pomeni pomembno korist za nekatere bolnike.
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.
CHMP je zaključil, da ima zdravilo Rivastigmine Hexal pri zdravljenju simptomov Alzheimerjeve demence skromen učinek, čeprav ta pomeni pomembno korist za nekatere bolnike.
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.
CHMP je zaključil, da ima zdravilo Rivastigmine Sandoz pri zdravljenju simptomov Alzheimerjeve demence skromen učinek, čeprav ta pomeni pomembno korist za nekatere bolnike.
The CHMP concluded that Sylvant has been shown to have a beneficial effect by reducing tumour size and symptoms in patients with multicentric Castleman’s disease, and that this positive effect seems to be maintained over time.
Odbor CHMP je zaključil, da je bilo dokazano, da ima zdravilo Sylvant ugoden učinek na zmanjšanje velikosti tumorjev in simptomov pri bolnikih z multicentrično Castlemanovo boleznijo in da se ta pozitiven učinek ohrani dlje časa.
The CHMP concluded that Telzir, which contains a prodrug of amprenavir, provides an advantage for patients, as the number of tablets they need to take is reduced when compared to the number of Agenerase capsules that they would need to take for the same dose of amprenavir.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da ima zdravilo Telzir, ki vsebuje predzdravilo amprenavirja, za bolnike prednost, saj morajo za enak odmerek amprenavirja, ki bi ga prejeli s kapsulami zdravila Agenerase, vzeti manjše število tablet zdravila Telzir.
The CHMP concluded that the benefits of Afinitor are greater than its risks and recommended that it be granted marketing authorisation.
Zaključil je, da so koristi zdravila Afinitor večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP concluded that the benefits of Caprelsa outweigh its risks in patients whose disease is both aggressive and causes symptoms, since they are in urgent need of treatment.
CHMP je sklenil, da so koristi zdravila Caprelsa večje od njegovih tveganj pri tistih bolnikih, pri katerih se bolezen pojavlja v agresivni obliki in povzroča simptome, saj zdravljenje nujno potrebujejo.
The CHMP concluded that the benefits of EndolucinBeta outweigh the risks and recommended that it be given marketing authorisation.
Odbor CHMP je zaključil, da so koristi zdravila EndolucinBeta večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP concluded that the benefits of Esmya outweigh its risks and recommended that it be granted marketing authorisation.
CHMP je zaključil, da so koristi zdravila Esmya večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP concluded that the benefits of Forxiga outweigh its risks and recommended that it be granted marketing authorisation.
CHMP je zaključil, da so koristi zdravila Forxiga večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP concluded that the benefits of Kalydeco are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Kalydeco večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP concluded that the benefits of Lumark outweigh the risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Lumark večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP concluded that the benefits of Plenadren were greater than its risks and recommended that it be granted marketing authorisation.
CHMP je zaključil, da so koristi zdravila Plenadren večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP concluded that the benefits of Signifor outweigh its risks and recommended that it be granted marketing authorisation.
Odbor CHMP je zaključil, da so koristi zdravila Signifor večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP concluded that the effectiveness of Tysabri in MS had been clearly shown but because of its safety profile, it should only be used in patients who have a real need for the medicine either because their disease has failed to respond to a disease-modifying therapy or is getting rapidly worse.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da je bila učinkovitost zdravila Tysabri pri zdravljenju multiple skleroze jasno dokazana, vendar pa ga je zaradi njegovega varnostnega profila dopustno uporabljati le pri bolnikih, ki zdravilo resnično potrebujejo, bodisi ker se niso odzvali na zdravilo za spreminjanje poteka bolezni ali ker se bolezen hitro poslabšuje.
The CHMP concluded that the Invanz had shown its effectiveness, albeit with a limited number of severe cases treated during the studies in the treatment of abdominal infections, community-acquired pneumonia, gynaecological infections and diabetic foot infections.
CHMP je zaključil, da je zdravilo Invanz, kljub omejenemu številu zdravljenj resnih primerov v študijah, dokazalo svojo učinkovitost za zdravljenje okužb v trebušni votlini, zunajbolnišnične pljučnice, ginekoloških okužb in okužb diabetičnega stopala.
The CHMP concluded that the medicine showed a clinically relevant improvement in the time patients lived without their disease getting worse.
Odbor CHMP je zaključil, da je zdravilo povzročilo klinično pomembno izboljšanje časa preživetja bolnikov brez poslabšanja bolezni.
The CHMP concluded that the medicine’s effects were already well established, as esomeprazole-containing medicines have been authorised in EU countries since 2000, and that its short-term benefits had been demonstrated in studies where most patients’ symptoms cleared up in 2 weeks.
CHMP je zaključil, da so učinki zdravila že dobro znani, saj so zdravila, ki vsebujejo esomeprazol, odobrena za uporabo v državah EU že od leta 2000, in da so bile njegove kratkotrajne koristi prikazane v študijah, v katerih so simptomi pri večini bolnikov izginili v 2 tednih.