FrancophonIA/ELRC3.0 huggingface dataset:
English: • browsing the A-to-Z list of human or veterinary medicines evaluated by the Agency;
Slovenian: • brskanjem po abecednem seznamu (A-to-Z list) humanih ali veterinarskih zdravil, ki jih je ovrednotila agencija;
English: Some content is translated into other official European Union (EU) languages, including public summaries and product information in European public assessment reports (EPARs), question-and-answer documents for the public, information on recruitment, work programmes and summaries of the annual report.
Slovenian: Nekatere vsebine se prevajajo v druge uradne jezike Evropske unije (EU), vključno z javnimi povzetki in informacijami o zdravilih v evropskih javnih poročilih o oceni zdravila (EPAR), dokumenti z vprašanji in odgovori za javnost, informacijami o zaposlovanju, delovnimi programi in s povzetki letnega poročila.
English: These spontaneous reports of suspected side effects by healthcare professionals, patients or carers are used to continuously monitor the safety of medicines on the market and to ensure that their benefits continue to outweigh their risks.
Slovenian: Ta spontana poročila o domnevnih neželenih učinkih od zdravstvenih delavcev, bolnikov ali skrbnikov se uporabljajo za stalno spremljanje varnosti zdravil v prometu in zagotavljanje, da koristi zdravil še vedno odtehtajo tveganja.
English: However, some medicines can be supplied to individual patients under special conditions before they have been authorised.
Slovenian: Vendar se lahko nekatera zdravila uporabijo pri določenih bolnikih pod posebnimi pogoji, preden pridobijo dovoljenje za promet.
English: The Agency also recommends that you report any suspected side effects to the national competent authority.
Slovenian: Agencija prav tako priporoča, da vse domnevne neželene učinke prijavite pristojnemu nacionalnemu organu.
English: Journalists and other representatives of the press should contact our press office directly at press@ema.europa.eu.
Slovenian: Novinarji in drugi predstavniki medijev naj svoja vprašanja naslovijo neposredno naši službi za stike z javnostjo na naslovu press@ema.europa.eu.
English: The European Commission follows the opinion of the Agency in almost all cases.
Slovenian: Skoraj v vseh primerih upošteva mnenje agencije.
English: The Agency has a role in preparing scientific opinions on the quality, safety and efficacy of herbal medicines, to help harmonise this information across the EU.
Slovenian: Agencija pripravi znanstvena mnenja o kakovosti, varnosti in učinkovitosti zdravil rastlinskega izvora, s čimer prispeva k usklajevanju teh informacij po vsej EU.
English: My medicine has been evaluated by the Agency but is not available in my country.
Slovenian: Agencija je moje zdravilo ovrednotila, vendar ni na voljo v moji državi.
English: Food supplements are evaluated at national level, usually by the authorities that deal with food safety and labelling.
Slovenian: Prehranski dodatki se vrednotijo na nacionalni ravni; običajno je to v pristojnosti organov, odgovornih za varnost hrane in označevanje.
English: • browsing by therapeutic area or type of medicine.
Slovenian: • brskanjem po terapevtskih področjih ali vrsti zdravila (type of medicine).
English: The search is currently only available in English.
Slovenian: Iskanje je trenutno mogoče samo v angleškem jeziku.
English: A medicine that is authorised in the EU might not be authorised or marketed in countries outside the EU.
Slovenian: Zdravilo, ki je odobreno v EU, morda ni odobreno ali se ne trži v državah zunaj EU.
English: The European Medicines Agency charges pharmaceutical companies fees for the services it provides.
Slovenian: Evropska agencija za zdravila farmacevtskim družbam za svoje storitve zaračunava pristojbine.
English: The members of the Agency's Management Board and scientific committees, and its experts and staff are not permitted to have financial or other interests in the pharmaceutical industry that could affect their impartiality.
Slovenian: Člani upravnega odbora agencije in znanstvenih odborov ter strokovnjaki in zaposleni v agenciji ne smejo opravljati pridobitne dejavnosti ali imeti kakršnih koli drugih interesov na področju farmacevtske industrije, ki bi lahko vplivali na njihovo nepristranskost.
English: The Agency's main responsibility is the protection and promotion of public and animal health, by carrying out scientific evaluations of medicines for human and veterinary use.
Slovenian: Glavna odgovornost agencije je, da z izvajanjem znanstvenih vrednotenj zdravil za humano in veterinarsko uporabo varuje in spodbuja zdravje ljudi in živali.
English: These are also published on EMA's homepage.
Slovenian: Utrinki so objavljeni tudi na spletni strani agencije EMA.
English: These include clinical trials and compassionate-use programmes, which Member Sates regulate.
Slovenian: To vključuje klinična preskušanja in programe sočutne uporabe, ki jih urejajo države članice.
English: How are the Agency's committee members selected?
Slovenian: Kako se izbirajo člani odborov agencije?
English: If appropriate, please give the type of organisation you represent (e.g. patient organisation, pharmaceutical company, etc.)
Slovenian: Po potrebi navedite tudi vrsto organizacije, ki jo predstavljate (npr. organizacija bolnikov, farmacevtska družba itd.).
English: How can I search for a medicine on the Agency's website?
Slovenian: Kako lahko poiščem zdravilo na spletni strani agencije?
English: Currently, most of the information on the Agency's website is only available in English.
Slovenian: Trenutno je večina informacij na spletni strani agencije na voljo samo v angleškem jeziku.
English: They are not usually evaluated by medicines regulatory authorities, unless they contain a substance that has pharmacological activity or make a medicinal claim.
Slovenian: Regulativni organi za zdravila jih običajno ne vrednotijo, razen če vsebujejo snov, ki je farmakološko aktivna, ali če je zdravilna.
English: The Agency requires every patient and consumer organisation that it works with to provide financial statements, including details on donors and their contributions.
Slovenian: Vsaka organizacija bolnikov in potrošnikov, ki sodeluje z agencijo, mora predložiti svoje računovodske izkaze, vključno s podatki o donacijah in prispevkih.
English: What does the Agency not control?
Slovenian: Česa agencija ne nadzoruje?
English: How are fees organised at the Agency?
Slovenian: Kako so organizirane pristojbine pri agenciji?
English: To help us direct your query to the right people within the Agency, please indicate whether you are making your enquiry for personal reasons (e.g. a patient or carer, a student, a researcher, a healthcare professional, etc.) or on behalf of an organisation.
Slovenian: Da bomo vaše vprašanje napotili na pravo osebo v agenciji, vas prosimo, da navedete, ali postavljate vprašanje iz osebnih razlogov (npr. bolnik ali negovalec, študent, raziskovalec, zdravnik itd.) ali v imenu organizacije.
English: If you wish to use an acronym for the Agency, use 'EMA'.
Slovenian: Če želite agencijo poimenovati s kratico, za to uporabite izraz „EMA“.
English: During the evaluation procedure, the Agency publishes information relevant to the evaluation timetable in the agenda and minutes of the meetings of its relevant scientific committees.
Slovenian: Agencija med postopkom vrednotenja objavlja informacije glede razporeda vrednotenja v dnevnih redih in zapisniki sej zadevnih znanstvenih odborov.
English: Why can I not find information about a particular medicine on your website?
Slovenian: Zakaj na spletni strani ne najdem informacij o določenem zdravilu?
English: To stay up to date with the latest news, features and publications from the Agency, you can subscribe to our RSS feeds or follow EMA on Twitter.
Slovenian: Zadnje novice, objave in publikacije agencije lahko spremljate s prijavo na naše novice RSS ali s sledenjem agenciji EMA na Twitterju.
English: The Agency is also not in a position to provide medical advice or to confirm whether your symptoms are being caused by your medicine.
Slovenian: Prav tako ne more zagotoviti zdravniškega nasveta ali potrditi, ali simptome povzroča vaše zdravilo.
English: The Agency publishes the rules on these fees, including a list of the fees charged for each type of procedure.
Slovenian: Agencija objavlja pravilnik o pristojbinah, v katerem je seznam pristojbin za vsako posamezno vrsto postopka.
English: Can you recommend a medical specialist for my condition?
Slovenian: Ali mi lahko priporočite specialista za mojo bolezen?
English: The Agency is not involved in recruiting volunteers for clinical trials.
Slovenian: Agencija ne sodeluje pri naboru prostovoljcev za klinična preskušanja.
English: Medicines cannot be placed on the market without authorisation.
Slovenian: Zdravilo se ne sme dati v promet brez dovoljenja.
English: Questions about the Agency's website
Slovenian: Vprašanja o spletni strani agencije
English: Please note that this is an unofficial acronym.
Slovenian: Vendar je to samo neuradna kratica.
English: The Agency publishes information about all the medicines it assesses as a European public assessment report (EPAR).
Slovenian: Agencija informacije o vseh zdravilih, ki jih vrednoti, objavlja v obliki evropskega javnega poročila o oceni zdravila (EPAR).
English: In addition you may be eligible to take part in a clinical trial.
Slovenian: Poleg tega ste morda primerni za sodelovanje v kliničnem preskušanju.
English: The Agency does not have any commercial interests and does not get involved in the distribution of medicines.
Slovenian: Ne. Agencija nima nikakršnih trgovinskih interesov in ne sodeluje pri distribuciji zdravil.
English: This means that medicines that have received a central marketing authorisation via the Agency may not be available in all European Union (EU) Member States.
Slovenian: To pomeni, da zdravila, ki so bila odobrena s centraliziranim postopkom agencije, morda niso na voljo v vseh državah članicah Evropske unije (EU).
English: What does the Agency do?
Slovenian: Kaj dela agencija?
English: Does the Agency control advertising of medicines?
Slovenian: Ali agencija nadzira oglaševanje zdravil?
English: Can the Agency tell me when a medicine will be approved?
Slovenian: Ali lahko agencija napove, kdaj bo zdravilo odobreno?
English: The Agency is not involved in these decisions and does not have any information on pricing or reimbursement arrangements in Member States.
Slovenian: Agencija ne sodeluje pri sprejemanju teh odločitev in nima nobenih podatkov o dogovorih glede cene ali povračil v posameznih državah članicah.
English: You can do this either by talking to a healthcare professional, or in some cases, you can report the side effects directly to the national competent authority using online patient reporting forms or by telephone.
Slovenian: To lahko storite s posvetom pri zdravstvenem delavcu, v nekaterih primerih pa lahko neželene učinke prijavite neposredno pristojnemu nacionalnemu organu z uporabo spletnih obrazcev za prijavo ali po telefonu.
English: Questions about the evaluation of other substances
Slovenian: Vprašanja o vrednotenju drugih snovi
English: In the European Union (EU), advertising of prescription-only medicines directly to patients and consumers is forbidden.
Slovenian: V Evropski uniji (EU) je prepovedano neposredno oglaševanje zdravil, ki se predpisujejo in izdajajo le na recept, bolnikom in potrošnikom.
English: are prepared by the Committee on Herbal Medicinal Products (HMPC) and contain information about what a herbal medicine is used for, restrictions on its use, its undesirable effects and its interactions with other medicines.
Slovenian: „Rastlinske monografije Skupnosti“, ki jih pripravlja Odbor za zdravila rastlinskega izvora (HMPC), vsebujejo informacije o namenu uporabe zdravil rastlinskega izvora, omejitvah uporabe, neželenih učinkih in medsebojnem delovanju z drugimi zdravili.
English: In the European Union (EU), there are two ways of getting a marketing authorisation for a medicine: the centralised procedure, via the Agency, which results in a single marketing authorisation valid throughout the EU; national authorisation procedures, where individual EU Member States authorise medicines for use in their own territory.
Slovenian: V Evropski uniji (EU) je dovoljenje za promet z zdravilom mogoče pridobiti na dva načina: s centraliziranim postopkom prek agencije, rezultat katerega je enotno dovoljenje za promet z zdravilom, veljavno po vsej EU; z nacionalnim postopkom za pridobitev dovoljenja za promet z zdravilom, v katerem posamezna država članica EU odobri zdravilo za uporabo na svojem ozemlju.
English: No, the Agency is unable to recommend academic courses in regulatory affairs, medicine or any other discipline.
Slovenian: Ne, agencija ne more priporočiti študijev o regulativnih zadevah, medicine ali katerega koli drugega področja.
English: If you would like to take part in a clinical trial, you should discuss it with your doctor or nurse, who may be able to refer you for a suitable trial.
Slovenian: Če želite sodelovati v kliničnem preskušanju, se o tem posvetujte z zdravnikom ali medicinsko sestro, ki vas lahko napoti na primerno preskušanje.
English: The Agency has no control over these decisions.
Slovenian: Agencija na takšne odločitve nima vpliva.
English: It can also give scientific opinions on medicines at the request of Member States or the European Commission.
Slovenian: Na zahtevo držav članic ali Evropske komisije lahko izdaja tudi znanstvena mnenja o zdravilih.
English: Questions about the Agency
Slovenian: Vprašanja o agenciji
English: You can search for a medicine by entering its name under ‘search for medicines' on the website's homepage or in the ‘Find medicine' section, by:
Slovenian: Zdravilo lahko iščete tako, da na domači strani agencije v rubriki „Search for medicines“ (Iskanje zdravila) vnesete ime zdravila ali v razdelku „Find medicine“ (Poišči zdravilo) z:
English: The European Medicines Agency cannot accept side effect reports directly from patients.
Slovenian: Evropska agencija za zdravila ne more sprejeti prijave neželenega učinka neposredno od bolnikov.
English: Cosmetics are evaluated by authorities in each Member State.
Slovenian: Kozmetične izdelke vrednotijo organi v vsaki državi članici.
English: To find out if a medicine is currently available in your country through a compassionate-use programme, check with your national medicines regulatory authority or the company responsible for the medicine.
Slovenian: Ali je zdravilo trenutno na voljo v vaši državi v programu sočutne uporabe, lahko preverite pri nacionalnem regulativnem organu za zdravila ali družbi, ki je odgovorna za zdravilo.
English: The Agency also publishes a monthly newsletter called 'human medicines highlights', which provides key information on the Agency's recent activities on human medicines.
Slovenian: Agencija objavlja tudi mesečno glasilo Human Medicines Highlights, v katerem so predstavljene najpomembnejše informacije o najnovejših dejavnostih agencije na področju zdravil za uporabo v humani medicini.
English: How can I keep up to date with the Agency's opinions?
Slovenian: Kako lahko spremljam izdajanje mnenj agencije?
English: The Agency publishes the names of the actives substance of medicines currently under evaluation but cannot say when the medicines will be approved.
Slovenian: Agencija objavi imena zdravilnih učinkovin zdravil, ki so trenutno v postopku vrednotenja, vendar ne more napovedati, kdaj bodo zdravila odobrena.
English: The Agency does not have information on sales figures or prescription numbers for any medicine.
Slovenian: Agencija nima podatkov o prodaji ali številu izdanih receptov za katero koli zdravilo.
English: The Agency also supervises the safety of medicines in the EU after they have been authorised.
Slovenian: Agencija prav tako nadzira varnost zdravil v EU po pridobitvi dovoljenja za promet.
English: The Agency does not maintain a list of medical specialists and is unable to advise individual patients on where to seek treatment.
Slovenian: Agencija nima seznama zdravnikov specialistov in ne more svetovati posameznim bolnikom glede iskanja zdravljenja.
English: Questions about competing interests and transparency
Slovenian: Vprašanja o navzkrižju interesov in preglednosti
English: Can the Agency provide me with information on patents on medicines?
Slovenian: Mi agencija lahko zagotovi podatke o patentih za zdravila?
English: EMA/527628/2011 Rev. 1 Directorate
Slovenian: EMA/527628/2011, izd.
English: Although medicines evaluated by EMA receive an authorisation valid in the whole of the EU, decisions on where a medicine is marketed are made by the company that markets the medicine (the marketing-authorisation holder).
Slovenian: Čeprav zdravila, ki jih ovrednoti agencija EMA, pridobijo dovoljenje za promet, ki je veljavno v celotni EU, odločitve o tem, kje se bo zdravilo tržilo, sprejema družba, ki trži zdravilo (imetnik dovoljenja za promet z zdravilom).
English: Questions about clinical trials
Slovenian: Vprašanja o kliničnih preskušanjih
English: • cosmetics.
Slovenian: • kozmetičnih izdelkov.
English: You can also see information on clinical trials ongoing in Europe in the European Union Clinical Trials Register.
Slovenian: Informacije o kliničnih preskušanjih, ki potekajo v Evropi, si lahko ogledate v registru kliničnih preskušanj v Evropski uniji.
English: The Agency then sends this recommendation to the European Commission, which takes a binding decision on whether to grant a marketing authorisation.
Slovenian: Nato to priporočilo predloži Evropski komisiji, ki sprejme zavezujoči sklep o izdaji dovoljenja za promet z zdravilom.
English: The outcome of the Agency's evaluation is used by the European Commission to decide whether a medicine can be authorised for marketing in the European Union (EU).
Slovenian: Evropska komisija na podlagi rezultatov vrednotenj agencije odloča, ali je mogoče izdati dovoljenje za promet z zdravilom v Evropski uniji (EU).
English: How can I get onto a clinical trial?
Slovenian: Kako lahko sodelujem v kliničnih preskušanjih?
English: The Agency does not have up-to-date information on the availability of medicines in Member States.
Slovenian: Ne. Agencija nima posodobljenih podatkov o razpoložljivosti zdravil v državah članicah.
English: Can you help me to get hold of a medicine?
Slovenian: Mi lahko pomagate priti do zdravila?
English: For the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC), EMA publishes meeting highlights with evaluation outcomes of major public interest on the Friday following their monthly plenary meetings.
Slovenian: Agencija EMA utrinke s sej Odbora za zdravila za uporabo v humani medicini (CHMP) in Odbora za ocenjevanje tveganja na področju farmakovigilance (PRAC) z rezultati vrednotenj zdravil, ki so v širšem javnem interesu, objavi vsak petek po mesečnih plenarnih zasedanjih.
English: • food supplements;
Slovenian: • prehranskih dopolnil;
English: The Agency takes around a year to evaluate a medicine, at the end of which it issues a recommendation on whether the medicine should be approved.
Slovenian: Običajno potrebuje približno eno leto za postopek vrednotenja zdravila, po katerem izda priporočilo, ali naj se zdravilo odobri.
English: For the Committee for Advanced Therapies, the Committee (CAT) for Orphan Medicinal Products (COMP) and the Paediatric Committee (PDCO), EMA publishes monthly meeting reports in the week following the committee's plenary meeting.
Slovenian: Agencija EMA objavlja mesečna poročila s sej Odbora za napredno zdravljenje (CAT), Odbora za zdravila sirote (COMP) in Odbora za pediatrijo (PDCO) v tednu po plenarni zasedanjih odbora.
English: How are food supplements evaluated?
Slovenian: Kako se vrednotijo prehranski dodatki?
English: They are not evaluated by the Agency.
Slovenian: Teh izdelkov ne vrednoti agencija.
English: The company producing a medicine can only market it once the medicine has received a marketing authorisation from the European Commission.
Slovenian: Družba, ki proizvaja zdravilo, ga lahko začne tržiti šele po pridobitvi dovoljenja za promet z zdravilom, ki ga izda Evropska komisija.
English: Information on medicines authorised in individual Member States through national procedures can only be obtained through the national medicines regulatory authorities.
Slovenian: Informacije o zdravilih, ki so bila odobrena v posameznih državah članicah z nacionalnimi postopki, so na voljo samo pri nacionalnih regulativnih organih za zdravila.
English: What acronym should I use for the Agency?
Slovenian: Katera kratica se uporablja za agencijo?
English: If you are experiencing a side effect or think you may be experiencing one, you should seek advice from a doctor or pharmacist.
Slovenian: Če se je pri vas pojavil neželeni učinek ali se vam zdi, da se je pojavil, se morate posvetovati z zdravnikom ali farmacevtom.
English: No, the Agency is unable to supply pens, mugs or other items branded with the Agency's logo.
Slovenian: Ne, agencija ne more dobaviti pisal, skodelic ali drugega blaga z logotipom agencije.
English: Only medicines evaluated by the Agency are available on the website.
Slovenian: Na spletni strani so navedena samo zdravila, ki jih je ovrednotila agencija.
English: The Agency is also unable to give any financial assistance to patients who are trying to get hold of a medicine.
Slovenian: Agencija prav tako ne more nuditi finančne pomoči bolnikom pri preskrbi z zdravili.
English: Each EPAR includes a summary for the public
Slovenian: Vsako evropsko javno poročilo o oceni zdravila (EPAR) vključuje povzetek za javnost.
English: Does the Agency have any information on the price or reimbursement of medicines in Member States?
Slovenian: Ima agencija podatke o ceni ali povračilih za zdravila v državah članicah?
English: What type of information is available on a medicine evaluated by the Agency?
Slovenian: Katere informacije o zdravilih, ki jih vrednoti agencija, so na voljo?
English: Questions about the availability of medicines
Slovenian: Vprašanja o razpoložljivosti zdravil
English: Can the Agency recommend academic courses?
Slovenian: Ali lahko agencija priporoči študij?
English: Can the Agency give me any advice on my treatment or medical condition?
Slovenian: Mi lahko agencija svetuje glede zdravljenja ali bolezni?
English: • homoeopathic medicines;
Slovenian: • homeopatskih zdravil;
English: The Agency's responsibilities are limited to the evaluation of medicines for authorisation purposes and their supervision once they are authorised.
Slovenian: Odgovornost agencije je omejena na vrednotenje zdravil za namen odobritve in nadzor zdravil po izdaji dovoljenja za promet.
English: Can the Agency supply me with branded merchandise?
Slovenian: Ali mi lahko agencija priskrbi blago z blagovno znamko?
English: The Agency cannot advise individual patients on their treatment or condition.
Slovenian: Ne. Agencija ne more svetovati posameznim bolnikom glede njihovega zdravljenja ali bolezni.
English: How can I get sales figures for a medicine?
Slovenian: Kako lahko pridobim podatke o prodaji zdravila?
English: Does the Agency have information on the availability of medicines in Member States?
Slovenian: Ima agencija podatke o razpoložljivosti zdravil v državah članicah?
English: How are competing interests monitored?
Slovenian: Kako se spremljajo navzkrižni interesi?
English: Questions about fees
Slovenian: Vprašanja o pristojbinah
English: • the availability of medicines;
Slovenian: • razpoložljivosti zdravil;
English: The European Patent Office may be able to provide information on a specific patent.
Slovenian: Informacije o posameznih patentih je mogoče dobiti pri Evropskem patentnem uradu.
English: The Agency publishes information on the medicines it evaluates at the time it makes a recommendation as well as after the European Commission has issued a marketing authorisation.
Slovenian: Agencija objavi informacije o zdravilih, ki so v postopku vrednotenja, ko je pripravljeno priporočilo in ko Evropska komisija izda dovoljenje za promet z zdravilom.