natgillin/translations-raw huggingface dataset:
• Tell your doctor immediately if you have or experience symptoms such as persistent high temperature, severe headache, nausea (feeling sick), tiredness, yellowing of the skin or eyes and vomiting.
• Če imate simptome, kot so dolgotrajna zvišana telesna temperatura, hud glavobol, navzeja
No new patients should start treatment with Zinbryta.
Poleg tega se zdravljenje z zdravilom Zinbryta ne sme predpisati nobenemu novemu bolniku.
• Do not start any new patients on Zinbryta.
• Zdravila Zinbryta ne smete uvesti pri nobenem novem bolniku.
Multiple sclerosis medicine Zinbryta suspended in the EU
Zinbryta, ki se uporablja za zdravljenje multiple skleroze
19 January 2015
19. januar 2015
The areas harmonised include:
Usklajena področja so:
The amended information to doctors and patients is available here.
Posodobljeni podatki za zdravnike in bolnike so na voljo tukaj.
Nasonex and associated names are currently marketed in the following Member States of the EU: Austria, Belgium, Bulgaria, Croatia, Cyprus1, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden and United Kingdom, as well as in Iceland and Norway.
Zdravilo Nasonex in povezana imena se trenutno tržijo v naslednjih državah članicah EU: v Avstriji, Belgiji, Bolgariji, na Hrvaškem, Cipru1, v Češki republiki, na Danskem, v Estoniji, na Finskem, v Franciji, Nemčiji, Grčiji, na Madžarskem, Irskem, v Italiji, Latviji, Litvi, Luksemburgu, na Malti, Nizozemskem, Poljskem, Portugalskem, v Romuniji, na Slovaškem, v Sloveniji, Španiji, na Švedskem in v Združenem kraljestvu ter na Islandiji in Norveškem.
The European Commission issued an EU-wide legally binding decision to implement these changes on 19 January 2015.
Evropska komisija je za uveljavitev teh sprememb 19. januarja 2015 izdala pravno zavezujoč sklep, veljaven po vsej Evropski uniji.
The company that markets these medicines is Merck Sharp & Dohme.
Družba, ki trži ta zdravila, je Merck Sharp & Dohme.
The CHMP also harmonised other sections of the SmPC, including sections 4.4 (special warnings and precautions for use), 4.6 (fertility, pregnancy and lactation), 4.8 (side effects) and 5.1 (pharmacodynamic properties).
CHMP je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavjem 4.4 (Posebna opozorila in previdnostni ukrepi), 4.6 (Plodnost, nosečnost in dojenje), 4.8 (Neželeni učinki) in 5.1 (Farmakodinamične lastnosti).
Why was Nasonex reviewed?
Zakaj je bilo zdravilo Nasonex pregledano?
The Committee also agreed that Nasonex should no longer be recommended to treat acute sinusitis, which was authorised in some Member States, because the available data to support this use were considered limited.
Odbor se je tudi strinjal, da zdravila Nasonex ne bi smeli več priporočati za zdravljenje akutnega sinusitisa, ki je bilo odobreno v nekaterih državah članicah, saj je menil, da so razpoložljivi podatki v podporo tej uporabi omejeni.
1 Nasonex is marketed in Cyprus under Art.126a of Directive 27/2004 EC, which allows a country to place a product in the market for justified public health reasons for a limited number of years.
1 Zdravilo Nasonex se na Cipru trži v skladu s členom 126a Direktive 2004/27/ES, ki državam dovoljuje, da zdravilo dajo na trg iz utemeljenih razlogov javnega zdravja za omejeno število let.
Questions and answers on Nasonex and associated names (mometasone furoate, 50 microgram, nasal spray)
Vprašanja in odgovori v zvezi z zdravilom Nasonex in povezanimi imeni (mometazonfuroat, 50 mikrogramov, pršilo za nos)
Nasonex and associated names have been authorised in EU Member States through national procedures since
Zdravilo Nasonex in povezana imena so bila od leta 1997 z nacionalnimi postopki odobrena v državah članicah EU.
On 20 November 2014, the European Medicines Agency completed a review of Nasonex and associated names.
Evropska agencija za zdravila je 20. novembra 2014 zaključila pregled zdravila Nasonex in povezanih imen.
The CHMP agreed to that Nasonex must not be used in:
CHMP se je strinjal, da se zdravilo Nasonex ne sme uporabljati pri:
Having harmonised the indications, the CHMP also harmonised recommendations on the doses.
Po uskladitvi indikacij je CHMP uskladil tudi priporočila o odmerkih.
Nasonex is an anti-inflammatory medicine that is used in adults and children from three years of age to treat the symptoms of seasonal allergic or perennial rhinitis (inflammation of the nasal passages caused by occasional or long-term allergy).
Nasonex je protivnetno zdravilo, ki se uporablja pri odraslih in otrocih, starih tri leta ali več, za zdravljenje simptomov sezonskega alergijskega ali celoletnega rinitisa (vnetja nosnih poti, ki ga povzroči občasna ali dolgotrajna alergija).
In view of this, on 17 September 2013 the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Nasonex in the EU.
Zato je Evropska komisija 17. septembra 2013 zadevo napotila na CHMP, da bi uskladila dovoljenja za promet z zdravilom Nasonex v EU.
After reviewing the available data supporting the medicine's use, the CHMP agreed that Nasonex can be used for the following:
Po pregledu razpoložljivih podatkov v podporo uporabi zdravila se je CHMP strinjal, da se zdravilo Nasonex lahko uporablja za:
What is Nasonex?
Kaj je zdravilo Nasonex?
• Patients with known hypersensitivity (allergy) to mometasone furoate or to any other ingredients.
• bolnikih z znano preobčutljivostjo (alergijo) na mometazonfuroat ali katero koli drugo sestavino;
As Nasonex has been authorised in the EU via national procedures, this has led to divergences across Member States in the way the medicine can be used, as seen in differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Ker je bilo zdravilo Nasonex v EU odobreno z nacionalnimi postopki, je to privedlo do razhajanj glede načina uporabe zdravila po posameznih državah članicah, kot je razvidno iz razlik med povzetki glavnih značilnosti zdravila, označevanjem in navodili za uporabo v državah, kjer se zdravilo trži.
• Treatment of nasal polyps in adults (aged 18 years and older).
• zdravljenje nosnih polipov pri odraslih (starih 18 let ali več).
Nasonex contains the active substance mometasone furoate.
Zdravilo Nasonex vsebuje zdravilno učinkovino mometazonfuroat.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Nasonex and associated names in the European Union (EU).
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba v Evropski uniji (EU) uskladiti podatke o predpisovanju zdravila Nasonex in povezanih imen.
• Patients who have an untreated and localised infection, such as herpes, affecting the inside of the nose.
• bolnikih z nezdravljeno lokalizirano okužbo, kot je herpes, ki se pojavi na nosni sluznici;
In addition, it is used in adults to treat nasal polyps (growths in the lining of the nose).
Poleg tega se uporablja za zdravljenje nosnih polipov (tvorb na nosni sluznici) pri odraslih.
• Treatment of symptoms of seasonal allergic or perennial rhinitis in adults and in children aged three and above.
• zdravljenje simptomov sezonskega alergijskega ali celoletnega rinitisa pri odraslih in otrocih, starih tri leta ali več;
The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets for Nasonex should be harmonised across the EU.
CHMP je ob upoštevanju predloženih podatkov in znanstvenih razprav v okviru Odbora menil, da je treba povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo za zdravilo Nasonex uskladiti po vsej EU.
• Patients who have recently undergone nose surgery or who have a wound in the nose, because
• bolnikih, ki so nedavno imeli operacijo nosu ali ki imajo rano v nosu, saj lahko zdravilo Nasonex vpliva na celjenje rane.
The labelling and package leaflet were also revised in line with the changes to the SmPC.
Označevanje in navodilo za uporabo sta bila prav tako spremenjena v skladu s spremembami povzetka glavnih značilnosti zdravila.
It is available as a nasal spray.
Na voljo je v obliki pršila za nos.
This summary was last updated in 06-2016.
Povzetek je bil nazadnje posodobljen 06-2016.
The European Commission granted a marketing authorisation valid throughout the European Union for Rasilez on 22 August 2007.
Evropska komisija je dovoljenje za promet z zdravilom Rasilez, veljavno po vsej Evropski uniji, izdala 22. avgusta 2007.
‘Essential' means that the hypertension has no obvious cause.
Izraz „esencialna“ pomeni, da za hipertenzijo ni očitnega vzroka.
The medicine's effects were maintained for up to a year in two of the studies.
V dveh študijah so se učinki zdravila ohranili do enega leta.
What measures are being taken to ensure the safe and effective use of Rasilez?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Rasilez?
It is available as tablets (150 and 300 mg).
Na voljo je v obliki tablet (150 mg in 300 mg).
Its use during the first three months of pregnancy and in women planning to become pregnant is not recommended.
Njegova uporaba ni priporočljiva v prvih treh mesecih nosečnosti ali pri ženskah, ki načrtujejo zanositev.
The full EPAR for Rasilez 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 Rasilez je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This is a summary of the European public assessment report (EPAR) for Rasilez.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Rasilez.
The recommended dose of Rasilez is 150 mg once a day.
Priporočeni odmerek zdravila Rasilez znaša 150 mg enkrat dnevno.
What benefit has Rasilez shown during the studies?
Kakšne koristi je zdravilo Rasilez izkazalo med študijami?
Other information about Rasilez
Druge informacije o zdravilu Rasilez
Rasilez has been studied in 14 main studies involving over 10,000 patients with essential hypertension.
Zdravilo Rasilez so proučevali v 14 glavnih študijah, v katere je bilo vključenih več kot 10 000 bolnikov z esencialno hipertenzijo.
Rasilez is used to treat essential hypertension (high blood pressure) in adults.
Zdravilo Rasilez se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih.
For more information about treatment with Rasilez, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Rasilez preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The blood pressure was measured in ‘millimetres of mercury' (mmHg).
Krvni tlak so merili v milimetrih živega srebra (mmHg).
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 Rasilez.
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.
This causes vasodilation (widening of the blood vessels), so that the blood pressure drops.
To povzroči vazodilatacijo (razširitev krvnih žil), zaradi česar se krvni tlak zniža.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rasilez have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Rasilez upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
The studies lasted between six and 52 weeks and the main measure of effectiveness was the change in blood pressure during either the resting phase of the heartbeat (‘diastolic') or when the chambers of the heart were contracting (‘systolic').
Študije so trajale od šest do 52 tednov, glavno merilo učinkovitosti pa je bila sprememba krvnega tlaka med mirovalno fazo srčnega utripa (diastolični tlak) ali med krčenjem srčnih komor srca (sistolični tlak).
The CHMP therefore decided that the benefits of Rasilez are greater than its risks and recommended that it be given marketing authorisation.
Poleg tega je zaključil, da so koristi zdravila Rasilez večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Thirteen of the studies included patients with mild to moderate hypertension, and one included patients with severe hypertension.
V trinajst študij so bili vključeni bolniki z blago do zmerno hipertenzijo, v eno pa bolniki s hudo hipertenzijo.
Rasilez should not be taken together with fruit juice or drinks containing plant extracts such as herbal teas.
Zdravila Rasilez se ne sme jemati skupaj s sadnim sokom ali pijačami, ki vsebujejo rastlinske izvlečke, kot so na primer zeliščni čaji.
When the results of the five studies comparing Rasilez taken alone with placebo were looked at together, patients aged under 65 years had an average fall in diastolic blood pressure of 9.0 mmHg after eight weeks of taking 150 mg Rasilez, from an average of 99.4 mmHg at the start of the study.
Ko so primerjali rezultate vseh petih študij, v katerih so zdravilo Rasilez kot samostojno zdravilo primerjali s placebom, se je pri bolnikih, mlajših od 65 let, po osmih tednih jemanja zdravila Rasilez v odmerku 150 mg povprečni diastolični tlak, ki je na začetku znašal 99,4 mmHg, v povprečju znižal za 9,0 mmHg.
The studies with Rasilez taken in combination with other medicines showed additional decreases in blood pressure compared with the decreases produced by these medicines alone.
Študije z zdravilom Rasilez v kombinaciji z drugimi zdravili so pokazale dodatno znižanje krvnega tlaka v primerjavi z znižanjem, ki so ga ta zdravila dosegla samostojno.
What is the risk associated with Rasilez?
Kakšna tveganja so povezana z zdravilom Rasilez?
Rasilez also reduced blood pressure in patients with diabetes and patients who were overweight.
Zdravilo Rasilez je krvni tlak znižalo tudi pri bolnikih s sladkorno boleznijo in tistih s prekomerno težo.
Rasilez is a medicine that contains the active substance aliskiren.
Rasilez je zdravilo, ki vsebuje zdravilno učinkovino aliskiren.
The CHMP noted that Rasilez is effective in reducing blood pressure when used alone or in combination.
CHMP je ugotovil, da je zdravilo Rasilez učinkovito pri zniževanju krvnega tlaka, kadar se uporablja samostojno ali v kombinaciji z drugim zdravilom.
Rasilez must not be used in patients who have had angioedema (swelling under the skin) with aliskiren, hereditary angioedema or angioedema of no obvious cause, or in women who are more than three months pregnant.
Zdravila Rasilez ne smejo uporabljati bolniki, pri katerih se je zaradi jemanja aliskirena pojavil angioedem (podkožno otekanje), bolniki z dednim angioedemom ali angioedemom brez očitnega vzroka ter ženske, ki so noseče več kot tri mesece.
Rasilez is for use in adults only; it must not be used in children aged less than 2 years and is not recommended for older children.
Ne sme se uporabljati pri otrocih, mlajših od dveh let, medtem ko njegova uporaba pri starejših otrocih ni priporočljiva.
Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (a substance that narrows blood vessels).
se pretvori v hormon angiotenzin II, ki deluje kot močan vazokonstriktor (učinkovina, ki oži krvne žile).
By blocking the production of angiotensin I, levels of both angiotensin I and angiotensin II fall.
Z zaviranjem tvorjenja angiotenzina I se zniža raven angiotenzina I in angiotenzina II.
Rasilez must also not be taken with ciclosporin, itraconazole or other medicines known as ‘potent P-glycoprotein inhibitors' (such as quinidine).
Prav tako se ne sme jemati skupaj s ciklosporinom, itrakonazolom ali drugimi zdravili, za katere je znano, da so močni zaviralci P-glikoproteina (kot je kinidin).
It blocks the activity of a human enzyme called renin, which is involved in the production of a substance called angiotensin I in the body.
Zavira dejavnost človeškega encima, imenovanega renin, ki v telesu sodeluje pri tvorjenju angiotenzina I. Angiotenzin I
The most common side effects with Rasilez (seen in between 1 and 10 patients in 100) are dizziness, diarrhoea, arthralgia (joint pain) and hyperkalaemia (high blood potassium levels).
Najpogostejši neželeni učinki zdravila Rasilez (opaženi pri 1 do 10 bolnikih od 100) so omotica, driska, artralgija (bolečine v sklepih) in hiperkaliemija (visoke ravni kalija v krvi).
Why has Rasilez been approved?
Zakaj je bilo zdravilo Rasilez odobreno?
In five of the studies, the effects of Rasilez taken alone were compared with those of placebo (a dummy treatment).
V petih študijah so učinke jemanja zdravila Rasilez, uporabljenega kot samostojno zdravilo, primerjali s placebom (zdravilom brez zdravilne učinkovine).
Rasilez, taken alone or in combination with other medicines, was also compared with other medicines for hypertension.
Zdravilo Rasilez so kot samostojno zdravilo ali v kombinaciji z drugimi zdravili primerjali tudi z drugimi zdravili za zdravljenje hipertenzije.
This may reduce the risks associated with high blood pressure, such as having a stroke.
Z znižanjem krvnega tlaka se lahko zmanjša tudi tveganje za bolezni, povezane z visokim krvnim tlakom, kot je na primer kap.
For the full list of all side effects reported with Rasilez, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Rasilez, glejte navodilo za uporabo.
However, in February 2012, following the review of a study called ALTITUDE, the CHMP recommended that Rasilez should not be used together with an ACE inhibitor or ARB in patients with diabetes or with moderate or severe kidney impairment because of an increase in the risk of cardiovascular and kidney problems.
Toda po pregledu študije ALTITUDE je CHMP februarja 2012 priporočil, naj se zdravilo Rasilez ne uporablja skupaj z zaviralcem encima angiotenzinske konvertaze ali zaviralcem angiotenzinskih receptorjev pri bolnikih s sladkorno boleznijo oziroma zmerno ali hudo okvaro ledvic zaradi povišanega tveganja za srčno-žilne težave in težave z ledvicami.
This was compared with a fall of 5.8 mmHg from 99.3 mmHg in the patients taking placebo.
Rezultate so primerjali z znižanjem pri bolnikih, ki so jemali placebo, pri katerih se je diastolični tlak, ki je na začetku znašal 99,3 mmHg, znižal za 5,8 mmHg.
The active substance in Rasilez, aliskiren, is a renin inhibitor.
Zdravilna učinkovina zdravila Rasilez, aliskiren, spada med zaviralce renina.
Rasilez on its own was more effective than placebo and as effective as comparator treatments in reducing blood pressure.
Zdravilo Rasilez kot samostojno zdravilo je bilo pri zniževanju visokega krvnega tlaka učinkovitejše od placeba in enako učinkovito kot zdravljenje s primerljivimi zdravili.
Combination studies looked at Rasilez used with an ACE inhibitor (ramipril), an ARB (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a diuretic (hydrochlorothiazide).
V študijah kombinacij zdravil so zdravilo Rasilez proučevali v kombinaciji z zaviralcem encima angiotenzinske konvertaze (ramiprilom), zaviralcem angiotenzinskih receptorjev (valsartanom), zaviralcem receptorjev beta (atenololom), zaviralcem kalcijevih kanalčkov (amlodipinom) in diuretikom (hidroklorotiazidom).
Larger falls were seen in patients aged 65 years or over and those taking higher doses of Rasilez.
Pri bolnikih, starejših od 65 let, in tistih, ki so jemali večje odmerke zdravila Rasilez, so opazili večje znižanje tlaka.
What is Rasilez used for?
Za kaj se zdravilo Rasilez uporablja?
Rasilez may be taken alone or in combination with other medicines for hypertension, with the exception of ‘angiotensin converting enzyme (ACE) inhibitors' or ‘angiotensin receptor blockers' (ARBs) in patients with diabetes, or moderate or severe kidney impairment.
Zdravilo Rasilez se lahko uporablja kot samostojno zdravilo ali v kombinaciji z drugimi zdravili za zdravljenje hipertenzije z izjemo zaviralcev encima angiotenzinske konvertaze (ACE) ali zaviralcev angiotenzinskih receptorjev (ARB) pri bolnikih s sladkorno boleznijo oziroma zmerno ali hudo okvaro ledvic.
How has Rasilez been studied?
Kako je bilo zdravilo Rasilez raziskano?
How is Rasilez used?
Kako se zdravilo Rasilez uporablja?
The dose of Rasilez may be increased to 300 mg once a day in patients whose blood pressure is not adequately controlled.
Pri bolnikih, pri katerih krvni tlak ni ustrezno uravnan, se lahko odmerek zdravila Rasilez poveča na 300 mg enkrat dnevno.
What is Rasilez?
Kaj je zdravilo Rasilez?
How does Rasilez work?
Kako zdravilo Rasilez deluje?
Rasilez in combination with an ACE inhibitor or an ARB must not be used in patients with diabetes, or moderate or severe kidney impairment.
Zdravilo Rasilez se v kombinaciji z zaviralcem encima angiotenzinske konvertaze ali zaviralcem encima angiotenzinskih receptorjev ne sme uporabljati pri bolnikih s sladkorno boleznijo oziroma zmerno ali hudo okvaro ledvic.
More information can be found here.
Več informacij je na voljo tukaj.
Each study lasted three to four months.
Vse študije so trajale od tri do štiri mesece.
In the context of a procedure under Article 20 of Regulation (EC) No 726/2004.
V okviru postopka iz člena 20 Uredbe (ES) št. 726/2004.
However it should be noted that patients in this study were given doses higher than the recommended dose (up to 10 mg twice a day).
Vendar je treba poudariti, da so bolniki v tej študiji prejemali večje odmerke od priporočenega (do 10 mg dvakrat na dan).
Corlentor must not be taken with a number of other medicines.
Zdravilo Corlentor se ne sme jemati skupaj s številnimi drugimi zdravili.
Corlentor received a marketing authorisation valid throughout the EU on 25 October 2005.
Za zdravilo Corlentor je bilo 25. oktobra 2005 izdano dovoljenje za promet, veljavno po vsej EU.
Heart failure
Srčno popuščanje
What measures are being taken to ensure the safe and effective use of Corlentor?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Corlentor?
It must not be used in women who are pregnant, breast-feeding or by women who could become pregnant and who are not using appropriate contraceptives.
Ne smejo ga uporabljati nosečnice, doječe matere ali ženske, ki bi lahko zanosile in ki ne uporabljajo ustreznih kontracepcijskih sredstev.
The main measure of effectiveness was how long patients could exercise on a bicycle or a treadmill, which was measured at the start and the end of each study.
Glavno merilo učinkovitosti je bilo, koliko časa so bolniki zdržali pri vadbi na sobnem kolesu ali tekaški stezi, merjeno na začetku in ob koncu vsake študije.
The main measure of effectiveness was a reduction in the risk of death due to heart problems and non-fatal heart attack.
Glavno merilo učinkovitosti je bilo zmanjšanje tveganja smrtnega izida zaradi težav s srcem in srčnih napadov brez smrtnega izida.
Other information about Corlentor
Druge informacije o zdravilu Corlentor
In stable angina, these symptoms appear during physical effort.
Pri stabilni angini pektoris se ti simptomi pojavijo med telesnim naporom.
The Agency decided that Corlentor's benefits are greater than its risks and it can be authorised for use in the EU.
Zato je zaključila, da so koristi zdravila Corlentor večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.