FrancophonIA/ELRC3.0 huggingface dataset:
English: Titanium dioxide (E171) Simethicone
Slovenian: Obloga: kopolimer metakrilne kisline in etilakrilata (1 : 1) smukec trietilcitrat titanov dioksid (E171) simetikon
English: OUTER CARTON - SKILARENCE 120 mg GASTRO RESISTANT TABLETS
Slovenian: ZUNANJA ŠKATLA - SKILARENCE 120 mg GASTROREZISTENTNE TABLETE
English: BLISTER FOIL - SKILARENCE 120 mg GASTRO RESISTANT TABLETS
Slovenian: PRETISNI OMOT S FOLIJO - SKILARENCE 120 mg GASTROREZISTENTNE TABLETE
English: BLISTER FOIL - SKILARENCE 30 mg GASTRO RESISTANT TABLETS
Slovenian: PRETISNI OMOT S FOLIJO - SKILARENCE 30 mg GASTROREZISTENTNE TABLETE
English: The kidney was identified as a major target organ of toxicity in non-clinical studies.
Slovenian: V predkliničnih študijah so dokazali, da je ledvica glavni tarčni organ toksičnosti.
English: Allergic skin reaction*
Slovenian: Bolezni kože in podkožja eritem pekoč občutek na koži pruritus alergične reakcije na koži*
English: Midday
Slovenian: Opoldne
English: decrease in all white blood cells (leukopenia) - reddening of the face or body (flushing) - diarrhoea - bloating, stomach pain or stomach cramps - feeling sick (nausea)
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): - upadanje števila belih krvničk, imenovanih limfociti (limfopenija) - upadanje števila vseh belih krvničk (levkopenija) - rdečina obraza ali telesa (zardevanje) - driska - napihnjenost, bolečine v trebuhu ali trebušni krči - slabost
English: Dyspepsia
Slovenian: Odmerek
English: Common Common Uncommon Not known
Slovenian: pogosti pogosti občasni neznana
English: Common
Slovenian: United Kingdom
English: OTHER
Slovenian: b
English: Investigations
Slovenian: Ocena
English: How to store Skilarence
Slovenian: Shranjevanje zdravila Skilarence
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema limfopenija levkopenija eozinofilija levkocitoza akutna limfatična levkemija* nereverzibilna pancitopenija*
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 July 2017
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21.
English: The committee considered that the study failed to show beneficial effects in the population studied.
Slovenian: Odbor je presodil, da s študijo pri proučevani populaciji niso dokazali koristnih učinkov.
English: After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Slovenian: Potem ko je odbor CHMP ocenil odgovore družbe na zadnji sklop vprašanj, so nekatera vprašanja še vedno ostala nerešena.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it needed more time to collect additional information that the CHMP requested in relation to this application.
Slovenian: Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da potrebuje več časa za zbiranje dodatnih informacij, ki jih je odbor CHMP zahteval v povezavi s to vlogo.
English: The company presented results of a main study in 168 patients looking at the effects of the medicine on exacerbations (sudden worsening of symptoms) of the disease.
Slovenian: Družba je predstavila rezultate glavne študije pri 168 bolnikih o učinkih zdravila na izbruhe (nenadna poslabšanja simptomov) bolezni.
English: A lack of this enzyme can cause damage to the lungs (such as emphysema and airway obstruction) which leads to breathing problems.
Slovenian: Pomanjkanje tega encima lahko povzroči poškodbe pljuč (kot sta emfizem in zapora dihalnih poti), ki privedejo do težav z dihanjem.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Slovenian: Vloga je bila umaknjena po tem, ko je odbor CHMP že ocenil dokumentacijo, ki jo je predložila družba, in oblikoval seznam vprašanj.
English: Withdrawal of the marketing authorisation application for Infinia (alpha-1-antitrypsin) EMA/440995/2017
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Infinia (antitripsin alfa-1) EMA/440995/2017
English: There were also concerns that patients taking Infinia may produce antibodies against it which could reduce its effects or make patients more prone to allergic reactions.
Slovenian: Obstajali so tudi pomisleki, da se pri bolnikih, ki jemljejo zdravilo Infinia, lahko pojavijo protitelesa proti zdravilu, kar bi zmanjšalo njegove učinke ali pa bi bolniki postali dovzetnejši za alergijske reakcije.
English: The medicine was compared with placebo (a dummy treatment) and the main measure of effectiveness was the length of time patients went without having an exacerbation.
Slovenian: Zdravilo so primerjali s placebom (zdravilom brez zdravilne učinkovine), glavno merilo učinkovitosti pa je bilo trajanje obdobja, v katerem bolniki niso doživeli izbruha.
English: How does Infinia work?
Slovenian: Kako zdravilo Infinia deluje?
English: In addition, there were concerns about the tolerability and safety profile of the medicine, since patients who were taking Infinia had to stop treatment due to side effects more often than patients taking placebo.
Slovenian: Poleg tega so obstajali pomisleki o prenašanju zdravila in njegovem varnostnem profilu, saj so morali bolniki, ki so jemali zdravilo Infinia, zaradi neželenih učinkov pogosteje prekiniti zdravljenje kot bolniki, ki so jemali placebo.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes using Infinia.
Slovenian: Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Infinia.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Infinia did not outweigh its risks.
Slovenian: Zato je odbor CHMP ob umiku vloge menil, da koristi zdravila Infinia ne odtehtajo z njim povezanih tveganj.
English: What was Infinia expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Infinia uporabljalo?
English: On 21 June 2017, Kamada BioPharma Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Infinia, for the treatment of adults with lung disease due to congenital deficiency of alpha-1antitrypsin.
Slovenian: Družba Kamada BioPharma Limited je dne 21. junija 2017 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Infinia, namenjenim za zdravljenje odraslih s pljučno boleznijo, ki je posledica prirojenega pomanjkanja antitripsina alfa-1.
English: What is Infinia?
Slovenian: Kaj je zdravilo Infinia?
English: It is obtained from human blood and was intended to replace the missing protein in the lungs of patients with alpha-1-antitrypsin deficiency.
Slovenian: Pridobiva se iz človeške krvi in naj bi nadomestila manjkajočo beljakovino v pljučih bolnikov s pomanjkanjem antitripsina alfa-1.
English: Infinia is a medicine containing the active substance alpha-1-antitrypsin (also known as alpha1proteinase inhibitor).
Slovenian: Infinia je zdravilo, ki vsebuje zdravilno učinkovino antitripsin alfa-1 (znan tudi kot zaviralec proteinaze alfa1).
English: The active substance in Infinia, alpha-1-antitrypsin, is a protein in the blood which protects lung tissue from damage.
Slovenian: Zdravilna učinkovina v zdravilu Infinia, antitripsin alfa-1, je beljakovina v krvi, ki pljučno tkivo ščiti pred poškodbo.
English: Withdrawal of the marketing authorisation application for Infinia (alpha-1-antitrypsin)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Infinia (antitripsin alfa-1)
English: Other medicines containing alpha-1-antitrypsin are authorised in the EU for the same disease but are given as an infusion (drip) into a vein.
Slovenian: Za isto bolezen so v EU odobrena tudi druga zdravila, ki vsebujejo antitripsin alfa-1, vendar se dajejo z infundiranjem (kapalno infuzijo) v veno.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Infinia could not have been approved for the treatment of adults with lung disease due to congenital deficiency of alpha-1-antitrypsin.
Slovenian: Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Infinia ni mogoče odobriti za zdravljenje odraslih s pljučno boleznijo, ki je posledica prirojenega pomanjkanja antitripsina alfa-1.
English: It was to be available as a solution to be inhaled.
Slovenian: Na voljo naj bi bilo v obliki raztopine za inhaliranje.
English: The medicine was expected to be used for treating lung disease in adults with congenital (inborn) deficiency of alpha-1-antitrypsin.
Slovenian: Zdravilo naj bi se uporabljalo za zdravljenje pljučne bolezni pri odraslih s kongenitalnim (prirojenim) pomanjkanjem antitripsina alfa-1.
English: Infinia was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 16 November 2004 for the treatment of emphysema due to congenital alpha-1-antitrypsin deficiency.
Slovenian: Zdravilo Infinia je bilo 16. novembra 2004 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje emfizema, ki je posledica prirojenega pomanjkanja antitripsina alfa-1.
English: In addition, the company will perform a study to further investigate the risk of blood clots.
Slovenian: Poleg tega bo družba izvedla študijo, v kateri bo dodatno raziskala tveganje za nastanek krvnih strdkov.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoely on 27 July 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Zoely, veljavno po vsej Evropski uniji, izdala 27. julija 2011.
English: Zoely nomegestrol acetate / estradiol
Slovenian: Zoely nomegestrolacetat/estradiol
English: What measures are being taken to ensure the safe and effective use of Zoely?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zoely?
English: One tablet a day is taken for as long as contraception is required, starting with an active tablet on the first day of the cycle.
Slovenian: Vzeti je treba eno tableto na dan, dokler je potrebna kontracepcija, pri čemer je treba začeti z aktivno tableto na prvi dan ciklusa.
English: A lower Pearl Index represents a lower chance of getting pregnant.
Slovenian: Nižji Pearlov indeks pomeni manjšo možnost zanositve.
English: Zoely is a contraceptive pill.
Slovenian: Zdravilo Zoely je kontracepcijska tableta.
English: Other information about Zoely
Slovenian: Druge informacije o zdravilu Zoely
English: No clinical study data on Zoely are available in adolescents under 18 years old.
Slovenian: Podatki iz kliničnih študij zdravila Zoely pri mladostnicah, mlajših od 18 let, niso na voljo.
English: Zoely was investigated in two main studies involving a total of 4,433 women aged 18 to 50 years old.
Slovenian: Zdravilo Zoely so proučevali v dveh glavnih študijah, v kateri je bilo vključenih 4 433 žensk v starosti od 18 do 50 let.
English: The full EPAR for Zoely can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zoely je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The main measure of effectiveness was the number of women aged 18 to 35 who became pregnant during or shortly after treatment, expressed in terms of a pregnancy rate using the ‘Pearl Index'.
Slovenian: Glavno merilo učinkovitosti je bilo število žensk v starosti od 18 do 35 let, ki so zanosile v času jemanja zdravila ali kmalu po njegovem prenehanju, izraženo s stopnjo nosečnosti ob uporabi „Pearlovega indeksa“.
English: The Pearl Index is a standard way of measuring the effectiveness of contraceptives, which measures how many unwanted pregnancies occur in 100 women-years (corresponding to 1,300 menstrual cycles).
Slovenian: Pearlov indeks je standardni način za merjenje učinkovitosti kontracepcijskih sredstev, ki meri število neželenih nosečnosti na 100 žensk na leto (kar ustreza 1 300 menstrualnim ciklom).
English: The most frequent side effects with Zoely (seen in more than 1 user in 10) are acne and changes to menstrual periods (e.g. absence or irregularity).
Slovenian: Najpogostejši neželeni učinki zdravila Zoely (opaženi pri več kot 1 uporabnici od 10) so akne in spremembe menstruacije (npr. odsotnost ali nerednost).
English: In women aged 18 to 35, the Pearl Index was around 0.4 with Zoely and 0.8 with the comparator medicine in the first study, and around 1.2 with Zoely and 1.9 with the comparator medicine in the second study.
Slovenian: Pri ženskah v starosti od 18 do 35 let je znašal Pearlov indeks v prvi študiji približno 0,4 z zdravilom Zoely in 0,8 s primerjalnim zdravilom, v drugi študiji pa približno 1,2 z zdravilom Zoely in 1,9 s primerjalnim zdravilom.
English: This is a summary of the European public assessment report (EPAR) for Zoely.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zoely.
English: What benefit has Zoely shown during the studies?
Slovenian: Kakšne koristi je zdravilo Zoely izkazalo med študijami?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoely, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: For more information about treatment with Zoely, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Zoely preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: It should not be used in women who have pancreatitis (inflammation of the pancreas), severe liver problems, liver tumours or a history of liver tumours, certain types of cancer, or abnormal bleeding from the genital area whose cause has not been diagnosed.
Slovenian: Ne sme se uporabljati pri ženskah s pankreatitisom (vnetjem trebušne slinavke), hudim obolenjem jeter, tumorji na jetrih ali anamnezo tumorjev na jetrih, določenimi vrstami raka ali nenormalnimi krvavitvami v genitalnem predelu, katerih vzrok še ni bil ugotovljen.
English: A risk management plan has been developed to ensure that Zoely is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Zoely je bil pripravljen načrt obvladovanja tveganj.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zoely.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Estradiol is the same as a hormone naturally produced by the ovaries during a menstrual cycle.
Slovenian: Estradiol je popolnoma enak hormonu, ki naravno nastaja v jajčnikih med menstrualnim ciklom.
English: Zoely must not be used when a woman has, or has had, blood clots in the veins or arteries or when a woman has some of the risk factors for blood clots.
Slovenian: Zdravilo Zoely se ne sme uporabljati pri ženskah, ki imajo ali so imele krvne strdke v venah ali arterijah ali ki imajo nekatere od dejavnikov tveganja za nastanek krvnih strdkov.
English: The CHMP decided that the benefits of Zoely are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: What is the risk associated with Zoely?
Slovenian: Kakšna tveganja so povezana z zdravilom Zoely?
English: Zoely comes in blisters containing 28 tablets (24 white tablets followed by 4 yellow tablets), which are taken in sequence using stickers to identify the days of the week for each tablet.
Slovenian: Zdravilo Zoely je na voljo v pretisnem omotu, ki vsebuje 28 tablet (24 belih tablet, ki jim sledijo 4 rumene tablete), ki se jemljejo zaporedno, za označevanje dneva v tednu pa se za vsako tableto uporabi nalepka z dnevno oznako.
English: Zoely is a medicine available as 24 white ‘active' tablets that contain the active substances nomegestrol acetate (2.5 mg) and estradiol (1.5 mg), and four yellow ‘inactive' (placebo) tablets that do not contain any active substance.
Slovenian: Zdravilo Zoely je na voljo v obliki 24 belih „aktivnih“ tablet, ki vsebujejo zdravilni učinkovini nomegestrolacetat (2,5 mg) in estradiol (1,5 mg), in štirih rumenih „neaktivnih“ (placebo) tablet, ki ne vsebujejo zdravilnih učinkovin.
English: Zoely works by changing the body's hormonal balance to prevent ovulation, by altering the cervical mucus and by thinning the endometrium (the lining of the womb).
Slovenian: Zdravilo Zoely deluje tako, da spremeni hormonsko ravnovesje telesa in s spremembo sluzi materničnega vratu in tanjšanjem endometrija (maternične sluznice) prepreči ovulacijo.
English: Nomegestrol acetate is derived from the hormone called progesterone which is also produced by the ovaries during a menstrual cycle.
Slovenian: Nomegestrolacetat nastane iz hormona, imenovanega progesteron, ki prav tako nastaja v jajčnikih med menstrualnim ciklom.
English: For the full list of all side effects reported with Zoely, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Zoely, glejte navodilo za uporabo.
English: Zoely is a combined contraceptive pill that contains two active substances, nomegestrol acetate (a progestogen) and estradiol (an oestrogen).
Slovenian: Zdravilo Zoely je kombinirana kontracepcijska tableta, ki vsebuje dve zdravilni učinkovini, nomegestrolacetat (progesteron) in estradiol (estrogen).
English: Why has Zoely been approved?
Slovenian: Zakaj je bilo zdravilo Zoely odobreno?
English: The participants were given either Zoely or another contraceptive pill containing drospirenone and ethinyl estradiol for one year (13 menstrual cycles).
Slovenian: Udeleženke študije so eno leto (13 menstrualnih ciklusov) prejemale bodisi zdravilo Zoely bodisi drugo kontracepcijsko tableto, ki je vsebovala drospirenon in etinilestradiol.
English: What is Zoely?
Slovenian: Kaj je zdravilo Zoely?
English: How has Zoely been studied?
Slovenian: Kako je bilo zdravilo Zoely raziskano?
English: How does Zoely work?
Slovenian: Kako zdravilo Zoely deluje?
English: How is Zoely used?
Slovenian: Kako se zdravilo Zoely uporablja?
English: What is Zoely used for?
Slovenian: Za kaj se zdravilo Zoely uporablja?
English: No guideline was given.
Slovenian: Smernice niso bile podane.
English: It may be considered appropriate that such additional measures are applied in the future in the light of any new information.
Slovenian: Morda bo primerno tovrstne dodatne ukrepe v luči novih informacij izvajati v prihodnje.
English: Low High
Slovenian: Nizka Visoka
English: The field study should fulfil the following criteria:
Slovenian: Terenska študija mora izpolnjevati naslednja merila:
English: NOEC: the concentration in the study at which no effects are observed.
Slovenian: NOEC: koncentracija v študiji, pri kateri ni opaženih nobenih učinkov.
English: However, the data provided for Tier B and C assessment do not comply with current standards.
Slovenian: Vendar podatki iz ocenjevanja stopnje B in C ne ustrezajo trenutnim standardom.
English: • Concentrations of moxidectin in the different target matrices.
Slovenian: • Koncentracije moksidektina v različnih ciljnih matricah.
English: The following findings should be reported:
Slovenian: Poročati je treba o naslednjih izsledkih:
English: Direct therapeutic benefits
Slovenian: Neposredne terapevtske koristi
English: Nevertheless, the results of this study supported the conclusion on persistence from the first study.
Slovenian: Kljub temu rezultati te študije podpirajo zaključek o obstojnosti iz prve študije.
English: Additional benefits
Slovenian: Dodatne koristi
English: In case of insufficient space on the label:
Slovenian: Če na nalepki ni dovolj prostora:
English: • The duration of the study should be three consecutive years in order to consider seasonal and annual variations.
Slovenian: • Trajanje študije naj bo tri leta zaporedoma, da se pri tem upoštevajo sezonska in letna nihanja.
English: P. promelas (early life stages)
Slovenian: P. promelas (zgodnje razvojne stopnje)
English: Quality, target animal safety, user safety, consumer safety and efficacy were not assessed in this referral procedure.
Slovenian: Kakovost, varnost ciljnih živalskih vrst, varnost uporabnikov in učinkovitost se v tem napotitvenem postopku niso ocenjevali.
English: • The study should be performed in one or more European geographical regions, representing worst case climatic and epidemiological conditions and adjacent to small water bodies.
Slovenian: • Študijo je treba izvesti v eni ali več evropskih geografskih regijah, ki predstavljajo najslabše klimatske in epidemiološke pogoje, v bližini majhnih vodnih teles.
English: The following conditions should be fulfilled by all marketing authorisation holders: Conditions
Slovenian: Vsi imetniki dovoljenj za promet z zdravilom morajo izpolnjevati naslednje pogoje: Pogoji
English: However, toxicity to sediment-dwelling organisms is still very likely.
Slovenian: Vendar pa je strupenost za organizme, ki živijo v sedimentu, še vedno zelo verjetna.
English: Not determined
Slovenian: Ni določeno
English: The aforementioned internal and external parasites are recognised as causing significant loss of production and negatively impacting on animal welfare.
Slovenian: Priznava se, da prej omenjeni notranji in zunanji paraziti povzročajo velike izgube pri prireji in negativno vplivajo na dobro počutje živali.
English: However, it has to be noted that the use of QSAR values as a substitute for experimental data for pharmaceuticals is not supported as no validated models are available for pharmaceuticals.
Slovenian: Treba pa je poudariti, da uporaba vrednosti QSAR kot nadomestka eksperimentalnih podatkov za zdravila ni podprta, saj za zdravila ni na voljo validiranih modelov.
English: Do not contaminate watercourses with the product.
Slovenian: Z zdravilom ne onesnažite vodotokov.
English: Other precautions regarding impact on the environment
Slovenian: Drugi previdnostni ukrepi v zvezi z vplivom na okolje
English: The conditions imposed on the marketing authorisations are described in Annex IV.
Slovenian: Pogoji, ki veljajo za dovoljenja za promet z zdravilom, so navedeni v Prilogi IV.
English: Add, to all products:
Slovenian: Vsem zdravilom dodajte:
English: A risk to the environment has been identified which can be partially mitigated by appropriate risk mitigation measures.
Slovenian: Ugotovljeno je bilo tveganje za okolje, ki ga je mogoče delno ublažiti s primernimi ukrepi za zmanjšanje tveganja.
English: Mineralisation (evolution of 14CO2) accounted for up to 5% of the applied radioactivity.
Slovenian: Mineralizacija (nastajanje 14CO2) je zajemala do 5 % dodane radioaktivnosti.
English: Daphnia magna (reproduction)
Slovenian: Daphnia magna (razmnoževanje)
English: Risk to the environment
Slovenian: Tveganje za okolje
English: Daphnia magna (acute)
Slovenian: Daphnia magna (akutno)
English: The final study report should be submitted to the CVMP for assessment.
Slovenian: Končno poročilo o študiji se predloži odboru CVMP v oceno.