natgillin/translations-raw huggingface dataset:
Three studies in over 3,200 patients showed that Relvar Ellipta improves breathing and reduces flareups in patients with asthma. 
Tri študije pri več kot 3 200 bolnikih so pokazale, da zdravilo Relvar Ellipta izboljša dihanje in zmanjša število poslabšanj pri bolnikih z astmo.
Four studies in over 5,500 patients showed that Relvar Ellipta improves breathing and reduces flareups of symptoms in patients with COPD. 
Štiri študije pri več kot 5 500 bolnikih so pokazale, da zdravilo Relvar Ellipta izboljša dihanje in zmanjša število poslabšanj simptomov pri bolnikih s KOPB.
Relvar Ellipta improves breathing and reduces flare ups of symptoms in patients with asthma and COPD. 
Zdravilo Relvar Ellipta izboljša dihanje in zmanjša število poslabšanj simptomov pri bolnikih z astmo in KOPB.
In two of the studies, Relvar Ellipta 92/22 increased the volume of air a patient could breathe out in one second (FEV1) by 36 ml more than fluticasone furoate alone and 172 ml more than placebo (a dummy treatment). 
V dveh študijah je zdravilo Relvar Ellipta z jakostjo 92/22 mg povečalo volumen zraka, ki ga bolnik lahko izdihne v eni sekundi (FEV1), za 36 ml v primerjavi s samostojnim flutikazonfuroatom in za 172 ml v primerjavi s placebom (zdravilom brez zdravilne učinkovine).
• whose symptoms are not controlled with an inhaled corticosteroid and an inhaled short-acting 
• katerih simptomi niso obvladovani z inhalacijskim kortikosteroidom in inhalacijskim kratkodelujočim agonistom adrenergičnih receptorjev beta2;
For the full list of side effects of Relvar Ellipta, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Relvar Ellipta, glejte navodilo za uporabo.
Relvar Ellipta contains the active substances fluticasone furoate and vilanterol. 
Zdravilo Relvar Ellipta vsebuje učinkovini flutikazonfuroat in vilanterol.
• whose symptoms are adequately controlled with both inhaled corticosteroids and a long-acting 
• katerih simptomi so ustrezno obvladovani z inhalacijskimi kortikosteroidi in dolgotrajno delujočim agonistom adrenergičnih receptorjev beta2.
How is Relvar Ellipta used? 
Kako se zdravilo Relvar Ellipta uporablja?
How does Relvar Ellipta work? 
Kako zdravilo Relvar Ellipta deluje?
Relvar Ellipta can only be obtained with a prescription. 
Predpisovanje in izdaja zdravila je le na recept.
The applicant presented data from one main study involving 167 patients who underwent vascular surgery. 
Predlagatelj je predstavil podatke iz ene glavne študije, v katero je bilo vključenih 167 bolnikov, ki so imeli vaskularni kirurški poseg.
The Committee was concerned that the main study had not been carried out in accordance with the guidelines for Good Clinical Practice (GCP). 
Odbor je izrazil zaskrbljenost, da glavna študija ni bila izvedena v skladu s smernicami dobre klinične prakse.
The main measure of effectiveness was the ability to stop bleeding during a 10-minute observation period, after applying the method to stop the bleeding. 
Glavno merilo učinkovitosti je bila zmožnost zaustavitve krvavitve med 10-minutnim obdobjem opazovanja po uporabi metode za zaustavitev krvavitve.
When applied to a moist surface, the thrombin is activated and cuts fibrinogen up into smaller units called fibrin. 
Ko ju nanesemo na vlažno površino, se trombin aktivira in pretvori fibrinogen v manjše enote, imenovane fibrini.
VeraSeal is a medicine that contains the active substances human fibrinogen and human thrombin. 
VeraSeal je zdravilo, ki vsebuje zdravilni učinkovini humani fibrinogen in humani trombin.
The active substances in VeraSeal, human fibrinogen and human thrombin, are natural proteins in the blood and are obtained from blood donors. 
Zdravilni učinkovini v zdravilu VeraSeal, humani fibrinogen in humani trombin, sta naravni beljakovini v krvi in se pridobivata iz darovane krvi.
There are no consequences for patients in the three ongoing clinical trials. 
Umik nima nobenih posledic za bolnike, ki sodelujejo v treh tekočih kliničnih preskušanjih.
The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions. 
Vlogo so umaknili po tem, ko je CHMP ocenil dokumentacijo, ki jo je predložila družba, in oblikoval sezname vprašanj.
It was to be available as two separate solutions that are mixed together to prepare a sealant that is applied to the surface of blood vessels. 
Na voljo naj bi bilo v obliki dveh ločenih raztopin, ki se zmešata za pripravo lepila, ki se nanese na površino krvnih žil.
Findings from a GCP inspection of the study sites raised serious questions about the data from the main study submitted in support of the application. 
Ugotovitve pri pregledu dobre klinične prakse na mestih izvajanja študije so vzbudile resne pomisleke o podatkih v glavni študiji, predloženi v podporo vlogi.
On 29 September 2015, Instituto Grifols S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for marketing authorisation of VeraSeal, which was intended to help stop bleeding during vascular (blood vessel) surgery when standard surgical methods for controlling bleeding are insufficient. 
Družba Instituto Grifols S.A. je 29. septembra 2015 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom VeraSeal, namenjenim pomoči pri ustavljanju krvavitve med vaskularnim kirurškim posegom (posegom na ožilju), kadar standardne kirurške metode za obvladovanje krvavitev ne zadoščajo.
In its letter notifying the Agency of the withdrawal of the applications, the company stated that the withdrawal was due to not being able to gather the additional data required by the CHMP, including data from three ongoing clinical studies with the product, within the available timeframe. 
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da vlogo umika, ker ni bila zmožna zbrati dodatnih podatkov, ki jih je od nje zahteval CHMP, vključno s podatki iz treh tekočih kliničnih preskušanj z zdravilom, v času, ki ga je imela na voljo.
The fibrin then aggregates (sticks together) and forms fibrin clots on the surface of blood vessels. 
Fibrini se nato združijo (medsebojno zlepijo) in ustvarijo fibrinske strdke na površini krvnih žil.
The company informed the CHMP that there are currently no ongoing compassionate use programmes for VeraSeal. 
Družba je obvestila CHMP, da se trenutno ne izvaja noben program sočutne uporabe zdravila VeraSeal.
This helps prevent bleeding and seals the blood vessels. 
To pomaga preprečiti krvavenje in zatesniti krvne žile.
What was VeraSeal expected to be used for? 
Za kaj naj bi se zdravilo VeraSeal uporabljalo?
VeraSeal was expected to be used to help stop bleeding during vascular surgery when standard surgical methods for controlling bleeding are insufficient. 
Zdravilo VeraSeal naj bi se uporabljalo za pomoč pri ustavljanju krvavitve med vaskularnim kirurškim posegom, kadar standardne kirurške metode za obvladovanje krvavitev ne zadoščajo.
How is VeraSeal expected to work? 
Kako naj bi zdravilo VeraSeal delovalo?
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal the CHMP had concerns and was of the provisional opinion that VeraSeal could not have been approved to help stop bleeding during vascular surgery. 
Na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih zastavil CHMP, je Odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila VeraSeal ni mogoče odobriti za pomoč pri ustavljanju krvavitve med vaskularnim kirurškim posegom.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for VeraSeal. 
Zato je CHMP v času umika menil, da družba ni predložila zadostnih podatkov v podporo vlogi za zdravilo VeraSeal.
What is VeraSeal? 
Kaj je zdravilo VeraSeal?
applying manual pressure (a standard way of stopping bleeding during surgery). 
V tej študiji so krvavitev med posegom obvladovali bodisi z nanosom zdravila VeraSeal bodisi z ročnim pritiskom (standardnim načinom za zaustavitev krvavitve med
This summary was last updated in 05-2008. 
Povzetek je bil nazadnje posodobljen 05-2008.
The European Commission granted a marketing authorisation valid throughout the European Union for Pelzont to Merck Sharp & Dohme Ltd. on 3 July 2008. 
Evropska komisija je dovoljenje za promet z zdravilom Pelzont, veljavno po vsej Evropski uniji, odobrila družbi Merck Sharp & Dohme Ltd dne 14. julija 2008.
It is taken by mouth, with food, in the evening or before going to bed. 
Zdravilo se jemlje peroralno, s hrano, zvečer ali pred spanjem.
Other information about Pelzont: 
Druge informacije o zdravilu Pelzont:
Pelzont is not recommended for use in children under 18 years of age because of a lack of information on its safety and effectiveness in this group. 
Zdravilo Pelzont ni priporočeno za zdravljenje otrok, starih manj kot 18 let, saj ni zadostnih informacij o varnosti in učinkovitosti v tej skupini.
In higher doses, it reduces the levels of fat in the blood via a mechanism that is not fully understood. 
Pri večjih odmerkih zmanjša ravni maščobe v krvi preko mehanizma, ki ga še ne razumemo popolnoma.
The tablets must be swallowed whole, and should not be split, broken, crushed or chewed. 
Tableto je treba pogoltniti celo, ne sme se je prelomiti, zlomiti, zdrobiti ali zgristi.
The starting dose of Pelzont is one tablet once a day for four weeks, after which the dose is increased to two tablets once a day. 
Začetni odmerek zdravila Pelzont je ena tableta enkrat dnevno štiri tedne, nato pa se odmerek poveča na dve tableti enkrat dnevno.
The Committee recommended that Pelzont be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Pelzont odobri dovoljenje za promet.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PELZONT EPAR summary for the public 
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) PELZONT Povzetek EPAR za javnost
Laropiprant blocks the receptors to which PGD2 normally attaches. 
Laropiprant blokira receptorje, na katere se običajno veže PGD2.
Primary means that the hypercholesterolaemia does not have any identifiable cause. 
Primarna pomeni, da za hiperholesterolemijo ni nobenega znanega vzroka.
The effects of Pelzont were first tested in experimental models before being studied in humans. 
Učinki zdravila Pelzont so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
What benefit has Pelzont shown during the studies? 
Kakšne koristi je zdravilo Pelzont izkazalo med študijami?
Pelzont is used on its own only in patients who cannot take statins. 
Zdravilo Pelzont se samostojno uporablja samo pri bolnikih, ki ne morejo jemati statina.
It should also not be used in patients who have problems with their liver, an active stomach ulcer or bleeding from an artery. 
Zdravila prav tako ne smejo uporabljati bolniki, ki imajo težave z jetri, aktivno želodčno razjedo ali krvavenje iz arterije.
The most common side effect with Pelzont (seen in more than 1 patient in 10) is flushing. 
Najpogostejši neželeni učinek zdravila Pelzont (opažen pri več kot 1 bolniku od 10) je zardevanje.
Two studies looked at the effectiveness of Pelzont in modifying blood fat levels. 
Dve študiji sta preučevali učinkovitost zdravila Pelzont pri uravnavanju ravni maščob v krvi.
The main measure of effectiveness was the change in the blood levels of LDL cholesterol after 12 weeks. 
Glavno merilo učinkovitosti je bila sprememba ravni LDL-holesterola v krvi po 12. tednih.
It was first used as a medicine to modify blood fat levels in the mid-1950s, but its use has been limited because of its side effects, particularly flushing (reddening of the skin). 
Zdravilo je bilo prvič uporabljeno za zmanjševanje ravni maščob v krvi v sredini petdesetih let, vendar je bila njegova uporaba zaradi neželenih učinkov, še zlasti zardevanja (pordelosti kože), omejena.
Pelzont is a medicine containing two active substances: nicotinic acid (also known as niacin or vitamin B3) and laropiprant. 
Pelzont je zdravilo, ki vsebuje dve zdravilni učinkovini: nikotinsko kislino (znano tudi kot niacin ali vitamin B3) in laropiprant.
When the receptors are blocked, PGD2 cannot dilate the vessels in the skin, reducing the frequency and intensity of flushing. 
Ko so receptorji blokirani, pa PGD2 ne more razširiti krvnih žil v koži, s čimer se zmanjšuje pogostnost in intenzivnost zardevanja.
What is the risk associated with Pelzont? 
Kakšna tveganja so povezana z zdravilom Pelzont?
Patients with combined mixed dyslipidaemia have high blood levels of ‘bad' LDL cholesterol and triglycerides (a type of fat), and low levels of ‘good' HDL cholesterol. 
Bolniki s kombinirano mešano dislipidemijo imajo v krvi visoko raven „slabega“ LDL-holesterola in trigliceridov (vrsta maščobe) ter nizko raven „dobrega“ HDLholesterola.
Flushing due to nicotinic acid is thought to occur because of the release of a substance called ‘prostaglandin D2' (PGD2) from cells in the skin, which dilates (widens) the blood vessels in the skin. 
Zardevanje zaradi nikotinske kisline naj bi se pojavljalo zaradi sproščanja učinkovine, imenovane prostaglandin D2 (PGD2), iz celic v koži, ki razširja (širi) krvne žile v koži.
They included a total of 2,349 patients who were taking either Pelzont or nicotinic acid. 
Študiji sta vključevali vsega skupaj 2349 bolnikov, ki so jemali zdravilo Pelzont ali nikotinsko kislino.
Pelzont was studied in four main studies in patients with hypercholesterolaemia or mixed dyslipidaemia. 
Zdravilo Pelzont so raziskovali v štirih glavnih študijah pri bolnikih s hiperholesterolemijo ali mešano dislipidemijo.
It is available as modified-release tablets. 
Na voljo je v obliki tablet s prirejenim sproščanjem.
The second study showed that the LDL cholesterol levels were further reduced when Pelzont was taken with simvastatin (48% reduction), compared with Pelzont alone (17% reduction) or simvastatin alone (37% reduction). 
V drugi študiji so dokazali, da je prišlo še do večjega znižanja ravni LDL-holesterola v skupini, ki je jemala zdravilo Pelzont skupaj s simvastatinom (48 % znižanje), v primerjavi s tisto, ki je jemala zdravilo Pelzont samostojno (17 % znižanje) ali samo simvastatin (37 % znižanje).
Primary hypercholesterolaemia is when the levels of cholesterol in the blood are high. 
Primarna hiperholesterolemija je stanje, pri katerem so ravni obeh holesterolov v krvi visoke.
In the first study, LDL cholesterol levels were reduced by 19% in patients taking Pelzont, compared with 1% in those taking placebo. 
V prvi študiji so se ravni LDL pri bolnikih, ki so jemali zdravilo Pelzont, znižale za 19 % v primerjavi z 1 % pri tistih, ki so jemali placebo.
Nicotinic acid is a naturally occurring substance that is used in low doses as a vitamin. 
Nikotinska kislina je naravno prisotna spojina, ki se v majhnih odmerkih uporablja kot vitamin.
Pelzont is normally given together with a statin (the standard medicine used to reduce cholesterol) when the effectiveness of a statin taken alone is inadequate. 
Zdravilo Pelzont se navadno daje skupaj s statinom (standardno zdravilo za zniževanje holesterola), kadar statin samostojno ni dovolj učinkovit.
The third and fourth studies looked at the effectiveness of laropiprant in reducing the flushing caused by nicotinic acid. 
V tretji in četrti študiji so raziskovali učinkovitost laropipranta pri zmanjšanju zardevanja, ki ga povzroča nikotinska kislina.
For the full list of all side effects reported with Pelzont, see the Package Leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Pelzont, glejte navodilo za uporabo.
Pelzont should not be used in people who may be hypersensitive (allergic) to nicotinic acid, laropiprant or any of the other ingredients. 
Zdravila Pelzont ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) nikotinsko kislino, laropiprant ali katero koli drugo sestavino zdravila.
Pelzont was effective in reducing the blood levels of LDL cholesterol. 
Zdravilo Pelzont je bilo učinkovito pri zniževanju ravni LDL-holesterola.
‘Modified-release' means that the two active substances are released at different rates from the tablet over a few hours. 
Prirejeno sproščanje pomeni, da se zdravilni učinkovini iz tablete v obdobju nekaj ur sproščata z različno hitrostjo.
The two active substances in Pelzont, nicotinic acid and laropiprant, have different modes of action. 
Zdravilni učinkovini v zdravilu Pelzont, nikotinska kislina in laropiprant, imata različna načina delovanja.
In Pelzont tablets, laropiprant is in one of the layers, and the other layer contains nicotinic acid. 
En sloj tablet zdravila Pelzont vsebuje laropiprant, drugi sloj pa vsebuje nikotinsko kislino.
This study also looked at the symptoms of flushing using a specially designed questionnaire. 
V tej študiji so s posebnim vprašalnikom raziskovali tudi simptome zardevanja.
Adding laropiprant to nicotinic acid reduced the symptoms of flushing caused by nicotinic acid. 
Če so laropiprantu dodali nikotinsko kislino, je prišlo do zmanjšanja simptomov zardevanja, ki jih povzroča nikotinska kislina.
In the first and third studies, fewer patients taking Pelzont reported moderate, severe or extreme flushing than patients taking nicotinic acid alone. 
V prvi in tretji študiji je o zmernem, hudem ali skrajnem zardevanju poročalo manj tistih bolnikov, ki so jemali Pelzont, kot tistih, ki so jemali samo nikotinsko kislino.
The first study compared the effectiveness of Pelzont with that of nicotinic acid alone or placebo (a dummy treatment) in reducing the levels of LDL cholesterol in a total of 1,613 patients. 
V prvi študiji so primerjali učinkovitost zdravila Pelzont s samostojno nikotinsko kislino ali placebom (zdravilom brez zdravilne učinkovine) pri zniževanju ravni LDL-holesterola pri vsega skupaj 1613 bolnikih.
The Committee for Medicinal Products for Human Use (CHMP) decided that Pelzont's benefits are greater than its risks for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia and in patients with primary hypercholesterolaemia. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Pelzont pri zdravljenju dislipidemije, zlasti pri bolnikih s kombinirano mešano dislipidemijo in bolnikih s primarno hiperholesterolemijo, večje od z njim povezanih tveganj.
When the patient takes the tablet, laropiprant is released first into the bloodstream and blocks the PGD2 receptors. 
Pri zaužitju tablete se tako v krvni obtok najprej sprosti laropiprant, ki blokira receptorje PGD2.
Flushing was measured using the flushing symptom questionnaire. 
Zardevanje so merili z vprašalnikom o simptomih zardevanja.
Why has Pelzont been approved? 
Zakaj je bilo zdravilo Pelzont odobreno?
In the fourth study, flushing was seen on fewer days in patients taking Pelzont than in those taking nicotinic acid alone. 
V četrti študiji je bilo število dni opaženega zardevanja manjše pri tistih bolnikih, ki so jemali zdravilo Pelzont kot pri tistih, ki so jemali samo nikotinsko kislino.
The nicotinic acid is released more slowly from the other layer and has its effect as a fatmodifying agent. 
Nikotinska kislina se iz drugega sloja sprošča počasneje in učinkuje kot sredstvo za uravnavanje maščob v krvi.
The full EPAR for Pelzont can be found here. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Pelzont je na voljo tukaj.
Pelzont is used in addition to diet and exercise in patients with dyslipidaemia (abnormally high levels of fat in the blood), particularly ‘combined mixed dyslipidaemia' and ‘primary hypercholesterolaemia'. 
Zdravilo Pelzont se uporablja kot dodatek k prehrani in telesni vadbi pri bolnikih z dislipidemijo (nenormalno visoka raven maščobe v krvi), zlasti pri tistih s kombinirano mešano dislipidemijo in primarno hiperholesterolemijo.
How has Pelzont been studied? 
Kako je bilo zdravilo Pelzont raziskano?
The second study compared the combination of Pelzont and simvastatin (a statin) with Pelzont alone or simvastatin alone in 1,398 patients. 
V drugi študiji so pri 1398 bolnikih primerjali kombinacijo zdravila Pelzont in simvastatin (vrsta statina) s samostojnim zdravilom Pelzont ali simvastatinom.
It should be used with caution in patients who have problems with their kidneys and should not be used in patients with liver problems. 
Pri bolnikih z ledvičnimi težavami je potrebna posebna previdnost pri uporabi zdravila Pelzont , pri bolnikih z jetrnimi težavami pa se zdravilo Pelzont ne sme uporabljati.
How is Pelzont used? 
Kako se zdravilo Pelzont uporablja?
What is Pelzont? 
Kaj je zdravilo Pelzont?
How does Pelzont work? 
Kako zdravilo Pelzont deluje?
What is Pelzont used for? 
Zakaj se zdravilo Pelzont uporablja?
and what is it used for? 
in za kaj se uporablja?
be approved for use in the EU. 
odobri za uporabo v EU.
may be given to adults or children from 3 years of age and weighing at least 15 kg. 
se lahko daje odraslim ali otrokom, starejšim od treh let, ki tehtajo najmanj 15 kg.
is available as tablets. 
je na voljo v obliki tablet.
can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
is a ‘generic medicine'. 
je „generično zdravilo“.
is always given with ritonavir. 
se vedno daje z ritonavirjem.
This allows effective treatment while avoiding a higher dose of darunavir. 
To prispeva k učinkovitemu zdravljenju in hkrati omogoča, da se bolnik izogne prejemanju višjega odmerka darunavirja.
For more information on generic medicines, see the questionand-answer document here. 
Za več informacij o generičnih zdravilih si oglejte dokument z vprašanji in odgovori, ki je na voljo tukaj.
is an antiviral medicine used with other HIV medicines to treat patients with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). 
je protivirusno zdravilo, ki se uporablja v kombinaciji z drugimi zdravili za zdravljenje okužbe z virusom HIV pri bolnikih, okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
does not cure HIV infection or AIDS, but HIV treatment may hold off the damage to the immune system and the development of infections and diseases associated with AIDS. 
ne zdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
When the enzyme is blocked, the virus does not reproduce normally, slowing down its multiplication in the body. 
Ko je encim zavrt, se virus v telesu ne razmnožuje več normalno, temveč upočasnjeno.
Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Prezista, and do not need to be repeated for Darunavir Krka d.d. 
Študije o koristih in tveganjih zdravilne učinkovine pri dovoljenih uporabah so že bile izvedene z referenčnim zdravilom Prezista, zato jih ni treba ponoviti za zdravilo Darunavir Krka d.d.
contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Prezista. 
To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot referenčno zdravilo Prezista, ki je že odobreno v Evropski uniji (EU).
The European Medicines Agency concluded that, in accordance with EU requirements, Darunavir Krka d.d. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Darunavir Krka d.d.
approved? 
odobreno?