natgillin/translations-raw huggingface dataset:
After the CHMP had assessed the company's responses to the first round of questions, there were still some unresolved issues.
Potem ko je CHMP ocenil odgovore družbe na prva vprašanja, so nekatera vprašanja še vedno ostala nerešena.
Therefore, at the time of the withdrawal, the CHMP's conclusion was that the vaccine could not have been approved since the company had not addressed the Committee's main concerns.
Zato je CHMP v času umika vloge menil, da cepivo ne more biti odobreno, saj družba ni odpravila glavnih zadržkov Odbora.
The CHMP was particularly concerned by shortcomings in good clinical practice (GCP) that came to light following an inspection of the sites of the main study.
Posebej je bil zaskrbljen zaradi pomanjkljivosti v dobri klinični praksi, ki so se pokazale po pregledu lokacij izvedbe glavne študije.
The children were given either Fluad Paediatric, another influenza vaccine (Agrippal or Influsplit) or a non-influenza vaccine (Menjugate or Encepur).
Otroci so prejeli bodisi zdravilo Fluad Paediatric, drugo cepivo proti gripi (Agrippal ali Influsplit) ali pa cepivo, ki ni namenjeno preprečevanju gripe (Menjugate ali Encepur).
Withdrawal of the marketing authorisation application for Fluad Paediatric (influenza vaccine, surface antigen, inactivated, adjuvanted) EMA/CHMP/114709/2012
Umik vloge za pridobitev dovoljenja za promet z zdravilom Fluad Paediatric (cepivo proti gripi, površinski antigen, inaktivirano, z adjuvansom) EMA/CHMP/114709/2012
It contains proteins from three inactivated influenza (flu) virus strains.
Vsebuje beljakovine iz treh inaktiviranih sevov virusa influence (gripe).
In its letter notifying the Agency of the withdrawal of application, the company stated that its withdrawal was based on the fact that it was unable to address the concerns of the CHMP within the required timelines.
Agencija je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da njen umik temelji na dejstvu, da ne more odpraviti zadržkov odbora CHMP v zahtevanem roku.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had several major concerns.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP, je CHMP v času umika izrazil določene večje zadržke.
Fluad Paediatric is a vaccine to protect against seasonal influenza.
Fluad Paediatric je cepivo za zaščito pred sezonsko gripo.
What is Fluad Paediatric?
Kaj je zdravilo Fluad Paediatric?
Withdrawal of the marketing authorisation application for Fluad Paediatric (influenza vaccine, surface antigen, inactivated, adjuvanted)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Fluad Paediatric (cepivo proti gripi, površinski antigen, inaktivirano, z adjuvansom)
Fluad Paediatric contains proteins from three influenza virus strains.
Zdravilo Fluad Paediatric vsebuje beljakovine iz treh sevov virusa gripe.
immune system will then be able to produce antibodies more quickly when it is exposed to the viruses again.
izpostavljen virusu, bo lahko hitreje izdelal protitelesa.
What was Fluad Paediatric expected to be used for?
Za kaj naj bi se zdravilo Fluad Paediatric uporabljalo?
How is Fluad Paediatric expected to work?
Kako naj bi zdravilo Fluad Paediatric delovalo?
This summary was last updated on 26/10/2011.
Povzetek je bil nazadnje posodobljen dne 26/10/2011.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part
Če želite več informacij o podlagi za priporočila CVMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
Because of the current epidemiological situation of avian influenza and the consequent threat to both human and animal health, the Committee recommended the granting of a Marketing Authorisation.
Zaradi trenutne epidemiološke situacije v zvezi z aviarno influenco in posledične grožnje za zdravje ljudi in živali je odbor priporočil odobritev dovoljenja za promet.
This kind of ‘reassortment' between H and N types happens naturally in the wild but in this case has been carried out in the laboratory to produce a virus with these very specific properties.
Ta vrsta »prerazporejanja« med tipoma H in N poteka v naravi spontano, v tem primeru pa je bila izvedena v laboratoriju z namenom, da bi izdelali virus s temi posebnimi lastnostmi.
The virus used for the vaccine is a recombinant virus.
Virus, uporabljen za cepivo, je rekombinantni virus.
The benefit-risk balance may be found in module 6 of this
Razmerje med koristmi in tveganji najdete v modulu 6 tega Evropskega javnega poročila o oceni
The results of studies of a similar vaccine on chickens free of any infection (containing the same ingredients, except for the virus) were also looked at.
Upoštevali so tudi rezultate raziskav, izvedenih s podobnim cepivom na neokuženih piščancih (vsebujočim enake sestavine, z izjemo virusa).
Inactivated recombinant avian influenza virus
Inaktivirani rekombinantni virus aviarne influence
The vaccine is injected intramuscularly (into the breast muscle) in chickens or subcutaneously (under the skin) in ducks, as two doses, 3 weeks apart.
Cepivo se injicira intramuskularno (v prsno mišico) pri piščancih ali subkutano (pod kožo) pri racah v dveh odmerkih v razmaku 3 tednov.
Laboratory studies were carried out looking at the safety of the vaccine after a single dose, an overdose and a repeated dose regimen.
Pri izvedenih laboratorijskih raziskavah so preučevali varnost cepiva po enem odmerku, po prevelikem odmerjanju in po režimu ponavljajočih se odmerkov.
In the future, if the birds are exposed to the avian flu virus, their immune systems will be able to make those antibodies quicker and this will help them fight the disease.
Če bodo ptice v prihodnosti izpostavljene virusu aviarne influence, bo njihov imunski sistem ta protitelesa tvoril hitreje in to jim bo pomagalo v boju proti bolezni.
The European Medicines Agency (EMA) will review additional information that will become available according to an agreed timetable and this summary will be updated as necessary.
Evropska agencija za zdravila (EMA) bo pregledala dodatne informacije, ki bodo dane na razpolago glede na sprejet časovni načrt, in
It has been made using a ‘recombinant DNA technique' (when genes are inserted into an organism) to carry the H5 (haemagglutinin 5) and N3 (neuraminidase 3) antigens.
Proizveden je bil z uporabo »rekombinantne DNK tehnologije« (pri tem se geni vstavijo v organizem) za prenašanje antigenov H5 (hemaglutinin 5) in N3 (nevraminidaza 3).
When it is given to birds, the animals' immune systems (their natural defences) learn how to make antibodies (a special type of protein) to fight the virus.
Ko ga ptice prejmejo, se imunski sistem teh živali (njihov naravni obrambni mehanizem) nauči tvoriti protitelesa (posebno vrsto beljakovine) za boj proti virusu.
The Committee for Medicinal Products for Veterinary Use concluded that the vaccine has been shown to be safe and to be effective in preventing disease in poultry and could be a useful tool in controlling an outbreak of avian influenza infection.
Odbor za zdravila za uporabo v veterinarski medicini je sklenil, da je bila dokazana učinkovitost cepiva pri preprečevanju bolezni pri perutnini in je lahko uporaben pripomoček pri nadzorovanju izbruha okužbe z aviarno influenco.
The vaccine was assessed in the context of an emergency situation which means that further studies with Poulvac FluFend H5N3 RG are still ongoing and will be assessed.
Cepivo je bilo ocenjeno v izrednih razmerah, kar pomeni, da nadaljnje raziskave z zdravilom Poulvac FluFend H5N3 RG še vedno potekajo in bodo ovrednotene v prihodnosti.
This strain has been chosen because it protects birds against the virulent H5N1 field strains (cross-protection), while allowing differentiation of vaccinated from infected birds.
Ta sev je bil izbran, ker varuje ptice pred virulentnimi divjimi sevi H5N1 (navzkrižna zaščita), hkrati pa omogoča razlikovanje cepljenih ptic od okuženih ptic.
The vaccine does not contain any ingredients that are likely to pose a risk for consumers of vaccinated
Cepivo ne vsebuje učinkovin, ki bi lahko predstavljale tveganje za ljudi, ki zaužijejo meso cepljenih
This is acceptable because of the current political and epidemiological situation in Europe with regard to avian
Za to ciljno vrsto terenske študije niso na voljo, kar je sprejemljivo zaradi sedanje politične in epidemiološke situacije v Evropi glede aviarne influenze.
Birds vaccinated with this vaccine make antibodies against these two chosen antigens.
Ptice, cepljene s tem cepivom, tvorijo protitelesa proti tema dvema izbranima antigenoma.
• The studies showed that the birds which receive the vaccine develop antibodies against the H5 subtype of the avian influenza virus.
• Raziskave so pokazale, da ptice, ki prejmejo cepivo, tvorijo protitelesa proti virusu aviarne influence podtipa H5.
• The vaccine has been shown to prevent clinical signs and mortality and reduce virus shedding in infected chickens and ducks.
• Dokazano je bilo, da cepivo preprečuje klinične znake in umrljivost ter zmanjšuje izločanje virusa pri okuženih piščancih in racah.
Poulvac FluFend H5N3 RG is a vaccine containing an inactivated avian influenza virus H5N3 (inactivated means that the virus has been killed so that it cannot cause the disease anymore).
Zdravilo Poulvac FluFend H5N3 RG je cepivo, ki vsebuje inaktivirani antigen virus aviarne influence podtipa H5N3 (inaktiviran pomeni, da je bil virus ubit, zaradi česar ne more več povzročiti bolezni).
The person who gives the vaccine should be careful to avoid
Oseba, ki daje cepivo, mora paziti, da si zdravila po nesreči ne samo
The European Commission granted a marketing authorisation valid throughout the European Union, for Poulvac FluFend H5N3 RG on 01.09.2006.
Evropska Komisija je dovoljenje za promet z zdravilom Poulvac FluFend H5N3 RG, veljavno po vsej Evropski uniji, odobrila dne 01.09.2006.
Poulvac FluFend H5N3 RG is a vaccine used in chickens and ducks to protect against avian influenza.
Zdravilo Poulvac FluFend H5N3 RG je cepivo, ki se uporablja pri piščancih in racah za zaščito pred aviarno influenco.
Vaccinated birds can be differentiated from infected birds by looking for antibodies against the N3 component.
Cepljene ptice je mogoče razlikovati od okuženih ptic na podlagi protiteles proti sestavini N3.
• If the circulating avian influenza field virus has a different N component to the N3 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic test to detect specific Neuraminidase antibodies.
• Če ima krožeči divji virus aviarne influence sestavino N, ki se razlikuje od sestavine N3 v cepivu, lahko cepljene ptice razlikujemo od okuženih z diagnostičnim testom za odkrivanje protiteles proti nevraminidazi.
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Koliko časa je potrebno počakati, preden se žival lahko zakolje in meso
Poulvac FluFend H5N3 RG has been authorised under “Exceptional Circumstances”.
Zdravilo Poulvac FluFend H5N3 RG je bilo odobreno v »izjemnih okoliščinah«.
Poulvac FluFend H5N3 RG is a vaccine.
Zdravilo Poulvac FluFend H5N3 RG je cepivo.
This means that it has yet not been possible to obtain complete information about Poulvac FluFend H5N3 RG.
To pomeni, da o zdravilu Poulvac FluFend H5N3 RG še ni bilo mogoče pridobiti vseh podatkov.
Other information about Poulvac FluFend H5N3 RG:
Druge informacije o zdravilu Poulvac FluFend H5N3 RG:
What is the risk associated with Poulvac FluFend H5N3 RG?
Kakšna tveganja so povezana z zdravilom Poulvac FluFend H5N3 RG?
Why has Poulvac FluFend H5N3 RG been approved?
Zakaj je bilo zdravilo Poulvac FluFend H5N3 RG odobreno?
A field trial
Izvedena
How has Poulvac FluFend H5N3 RG been studied?
Kako je bilo zdravilo Poulvac FluFend H5N3 RG raziskano?
What benefit has Poulvac FluFend H5N3 RG shown during the studies?
Kakšne koristi je zdravilo Poulvac FluFend H5N3 RG izkazalo med
How does Poulvac FluFend H5N3 RG work?
Kako zdravilo Poulvac FluFend H5N3 RG deluje?
What is Poulvac FluFend H5N3 RG used for?
Za kaj se zdravilo Poulvac FluFend H5N3 RG uporablja?
The effects of Ioa were first tested in experimental models before being studied in humans.
Učinki zdravila Ioa so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Ioa is a contraceptive pill.
Zdravilo Ioa je kontracepcijska tableta.
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.
Vzeti je treba eno tableto na dan, dokler je potrebna kontracepcija, pri čemer je treba začeti z aktivno tableto na prvi dan cikla.
Ioa was investigated in two main studies involving a total of 4,433 women aged 18 to 50 years old.
Zdravilo Ioa je bilo proučeno v dveh glavnih študijah, v katero je bilo vključenih 4 433 žensk v starosti od 18 do 50 let.
No clinical study data on Ioa are available in adolescents under 18 years old.
Podatki iz kliničnih študij zdravila Ioa za mladostnice, mlajše od 18 let, niso na voljo .
The full EPAR for Ioa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ioa je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
A lower Pearl Index represents a lower
Nižji Pearlov indeks pomeni manjšo možnost zanositve.
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'.
Glavno merilo učinkovitosti je bilo število žensk v starosti od 18 do 35 let, ki so zanosile med prejemanjem zdravila ali kmalu po njem, izraženo s stopnjo nosečnosti ob uporabi „Pearlovega indeksa“.
This is a summary of the European public assessment report (EPAR) for Ioa.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ioa.
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).
Pearlov indeks je standardni način za merjenje učinkovitosti kontraceptivov, ki meri število neželenih nosečnosti na 100 žensk na leto (kar ustreza 1 300 menstrualnim ciklom).
What benefit has Ioa shown during the studies?
Kakšne koristi je zdravilo Ioa izkazalo med študijami?
For more information about treatment with Ioa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Ioa preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
The most frequent side effects with Ioa (seen in more than 1 user in 10) are acne and changes to menstrual periods (e.g. absence or irregularity).
Najpogostejši neželeni učinki zdravila Ioa (opaženi pri več kot 1 od 10 uporabnic) so akne in spremembe menstruacije (npr. odsotnost ali nerednost).
For the full list of restrictions, see
Za celoten seznam omejitev glejte navodilo za uporabo.
What is the risk associated with Ioa?
Kakšna tveganja so povezana z zdravilom Ioa?
In women aged 18 to 35, the Pearl Index was around 0.4 with Ioa and 0.8 with the comparator medicine in the first study, and around 1.2 with Ioa and 1.9 with the comparator medicine in the
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.
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 Ioa.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Ioa, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
It should not be used in women who have a disorder affecting blood clotting (such as protein C deficiency), migraine with aura (visual or other symptoms), severe liver problems with the liver still not functioning normally, certain types of cancer, or abnormal bleeding from the genital area whose cause has not been diagnosed.
Ne sme se uporabljati pri ženskah, ki imajo motnje strjevanja krvi (na primer pomanjkanje proteina C), migreno z avro (vidni ali drugi simptomi), hudo jetrno bolezen in jetra še ne delujejo normalno, nekatere vrste raka ali nenormalne krvavitve iz spolnih organov, katerih vzrok še ni bil ugotovljen.
Nomegestrol acetate is derived from the hormone called progesterone which is also produced by the ovaries during a menstrual cycle.
Nomegestrol acetat nastane iz hormona, imenovanega progesteron, ki prav tako nastaja v jajčnikih med menstrualnim ciklom.
It must not be used when a woman has, or has had, venous or arterial thrombosis (blood clots in the veins or arteries) including a stroke or a heart attack or when a woman has some of the risk factors for thrombosis (severe high blood pressure, diabetes with damage to the blood vessels or high cholesterol levels).
Ne sme se uporabljati, če ženska ima ali je imela vensko ali arterijsko trombozo (krvni strdki v venah ali arterijah), vključno z možgansko kapjo ali srčnim infarktom, ali če ima nekatere izmed dejavnikov tveganja za trombozo (zelo visok krvni tlak, sladkorna bolezen z okvaro ožilja ali zelo visoka koncentracija holesterola v krvi).
Ioa 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.
Zdravilo Ioa je na voljo v pretisnem omotu, ki vsebuje 28 tablet (24 belih tablet, ki jim sledijo 4 rumene tablete), ki se jemljejo zaporedno ob uporabi označbe, za označevanje dneva v tednu pa se za vsako tableto uporabi nalepka z dnevno oznako.
Ioa 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).
Zdravilo Ioa deluje tako, da spremeni hormonsko ravnovesje telesa in s spremembo sluzi materničnega vratu in tanjšanjem endometrija (maternične sluznice) prepreči ovulacijo.
Ioa 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
Zdravilo Ioa je na voljo v obliki 24 belih „aktivnih“ tablet z zdravilnima učinkovinama nomegestrol acetatom (2,5 mg) in estradiolom (1,5 mg) in štirih rumenih „neaktivnih“ (placebo) tablet, ki ne vsebujejo zdravilnih učinkovin.
The CHMP decided that the benefits of Ioa are greater than its risks and recommended that it be given
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Ioa večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Ioa should not be used in women who are hypersensitive (allergic) to nomegestrol acetate, estradiol or any of the other ingredients.
Zdravila Ioa ne smejo uporabljati ženske, ki utegnejo bi preobčutljive za (alergične na) nomegestrol acetat, estradiol ali katero koli drugo sestavino zdravila.
Ioa is a combined contraceptive pill that contains two active substances, nomegestrol acetate (a progestogen) and estradiol (an oestrogen).
Zdravilo Ioa je kombinirana kontracepcijska tableta, ki vsebuje dve zdravilni učinkovini, nomegestrol acetat (progestogen) in estradiol (estrogen).
How has Ioa been studied?
Kako je bilo zdravilo Ioa raziskano?
The European Commission granted a marketing authorisation valid throughout the European Union for
Evropska komisija je dovoljenje za promet z zdravilom Ioa, veljavno po vsej Evropski uniji, odobrila dne 16. novembra 2011.
The participants were given either Ioa or another contraceptive pill containing drospirenone and ethinyl estradiol for one year (13 menstrual cycles).
Udeleženke študije so eno leto (13 menstrualnih ciklusov) prejemale bodisi zdravilo Ioa bodisi drugo kontracepcijsko tableto, ki je vsebovala drospirenon in etinilestradiol.
For the full list of all side effects reported with Ioa,
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ioa, glejte navodilo za uporabo.
Intravenous use
Pot uporabe Stična ovojnina
Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Dve zdravili sta biološko enakovredni takrat, kadar dosegata enake ravni zdravilne učinkovine v telesu.
This was considered acceptable since Revatio and Viagra have the same qualitative composition and are made in the same way by the same manufacturer.
To je bilo sprejemljivo, ker imata zdravili Revatio in Viagra enako kakovostno sestavo in ju enako izdeluje isti proizvajalec.
The full EPAR for Mysildecard can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Mysildecard je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
For lower doses, other medicines containing sildenafil should therefore be used.
Za manjše odmerke je torej treba uporabiti druga zdravila, ki vsebujejo sildenafil.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom dose would be 10 mg three times a day but Mysildecard can only be used when a 20 mg dose is to be given.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom je največji priporočeni odmerek 10 mg trikrat dnevno, zdravilo Mysildecard pa se lahko uporabi samo, če se daje 20-miligramski odmerek.
This is a summary of the European public assessment report (EPAR) for Mysildecard.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Mysildecard.
Because the effectiveness and safety of sildenafil in PAH is already well established, studies in people have been limited to tests to determine that it is bioequivalent to another authorised sildenafilcontaining tablet.
Ker sta učinkovitost in varnost sildenafila pri pljučni arterijski hipertenziji že dobro poznana, so bile študije na ljudeh omejene na preskuse za določanje, ali je biološko enakovredno drugemu zdravilu v tabletah, ki vsebuje sildenafil.
Because Mysildecard is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Mysildecard generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Mysildecard was considered to be comparable to Revatio.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Mysildecard primerljivo z zdravilom Revatio.
In this case Mysildecard was not compared with the reference product Revatio, but with Viagra.
V tem primeru zdravila Mysildecard niso primerjali z referenčnim zdravilom Revatio, ampak z zdravilom Viagra.
What measures are being taken to ensure the safe and effective use of Mysildecard?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Mysildecard?
In adults, it is used in patients with class II (slight limitation of physical activity) or class III (marked limitation of physical activity) PAH.
Pri odraslih se zdravilo uporablja pri bolnikih s pljučno arterijsko hipertenzijo razreda II (rahla omejitev fizične dejavnosti) ali III (znatna omejitev fizične dejavnosti).
Mysildecard is available as tablets (20 mg).
Zdravilo Mysildecard je na voljo v obliki tablet (20 mg).
The Committee recommended that Mysildecard be approved for use in the EU.
Priporočil je, da se zdravilo Mysildecard odobri za uporabo v EU.