FrancophonIA/ELRC3.0 huggingface dataset:
English: ‘Post-authorisation procedures' relate to the processing of applications received from marketingauthorisation holders (licensees) who wish to make changes to their authorised medicines, or who are obliged to do so (for example, to include new safety warnings in the prescribing information).
Slovenian: „Postopki po izdaji dovoljenja za promet“ se nanašajo na obdelavo vlog, prejetih od imetnikov dovoljenj za promet z zdravili (imetnikov licence), ki želijo spremeniti odobreno zdravilo ali morajo to storiti (na primer zaradi vključitve novih varnostnih opozoril v informacije za predpisovanje zdravila).
English: The Agency devoted much effort during the year to preparing for the entry into force of the EU's new Advanced Therapies Regulation - a piece of legislation that will greatly strengthen regulatory procedures relating to medicines at the cutting edge of medical science.
Slovenian: Agencija si je med letom posvetila močno prizadevala za pripravo uvedbe nove zakonodaje EU o zdravilih za napredno zdravljenje - delu zakonodaje za močno okrepitev regulativnih postopkov v zvezi z zdravili, ki so rezultat visoko razvite medicinske znanosti.
English: the first vaccine for adults against Japanese encephalitis, a disease transmitted by mosquitoes that causes inflammation of the brain and which can lead to long-term disability or death.
Slovenian: Prvo cepivo za odrasle proti japonskemu encefalitisu, bolezni, ki jo prenašajo komarji in povzroča vnetje možganov, kar povzroči dolgotrajno invalidnost ali smrt.
English: over 100 were type-II variation procedures that resulted in new information, including safety warnings or precautions, being added to the prescribing information for authorised medicines, thereby helping to reduce the risk of misuse or unwanted side-effects associated with the use of these medicines;
Slovenian: je bilo več kot 100 postopkov spremembe tipa II, ki so se končali z dodatkom novih informacij (vključno varnostnih opozoril in previdnostnih ukrepov) v informacije za predpisovanje odobrenih zdravil, kar pripomore k zmanjšanju tveganja napačne uporabe ali neželenih učinkov, ki so povezani z uporabo zadevnih zdravil;
English: In 2008, the HMPC: finalised 17 Community herbal monographs4 for traditional and well-established herbal medicines;
Slovenian: V letu 2008 je HMPC: dokončal 17 monografij rastlin Skupnosti4 za tradicionalna in dobro uveljavljena zdravila rastlinskega izvora;
English: Assessing applications for orphan designation
Slovenian: Vrednotenje vlog za določitev zdravila sirote
English: the first pre-pandemic vaccine for use in adults against the H5N1 subtype of the influenza-A virus, which may cause avian influenza in humans.
Slovenian: Prvo predpandemično cepivo za uporabo pri odraslih proti virusu influence A podtipa H5N1, ki lahko povzroči ptičjo gripo pri človeku.
English: 7 Centrally authorised medicines are ones that have been simultaneously approved in all EEA countries, through procedures operated by the European Medicines Agency, whereas non-centrally authorised medicines have been approved separately by one or more EEA countries.
Slovenian: Zdravila, za katera je bilo izdano dovoljenje po centraliziranem postopku, so tista, ki so bila sočasno odobrena v vseh državah EGP v postopkih, ki jih je vodila Evropska agencija za zdravila, zdravila, za katera ni bilo izdano dovoljenje po centraliziranem postopku, pa so bila ločeno odobrena v eni ali več državah EGP.
English: The year 2008 was one of consolidation and steady progress for the European Medicines Agency (EMEA), rather than one of major leaps and bounds.
Slovenian: Leto 2008 je bilo za Evropsko agencijo za zdravila (EMEA) leto utrjevanja in preudarnega napredka, in ne leto velikih korakov in mejnikov.
English: a new compound in an existing class of antiretroviral medicines that can be used to treat adults infected with HIV-1 (the virus that causes AIDS) in whom treatment with other medicines in the same class has been unsuccessful.
Slovenian: Nova spojina iz obstoječe skupine protiretrovirusnih zdravil, ki se lahko uporablja za zdravljenje odraslih bolnikov, okuženih z virusom HIV-1 (virusom, ki povzroča AIDS), pri katerih je bilo zdravljenje z drugimi zdravili iz iste skupine neuspešno.
English: One further application was withdrawn by the applicant before completion of the evaluation procedure.
Slovenian: Eno vlogo pa je vlagatelj umaknil pred zaključkom postopka ocenjevanja.
English: As part of its ongoing efforts to strengthen the efficiency of the network, the Agency focused in 2008 on:
Slovenian: Agencija se je v svojih prizadevanjih za krepitev učinkovitosti mreže v letu 2008 osredotočila na:
English: CAP EEA reports CAP non-EEA reports non-CAP EEA reports non-CAP non-EEA reports
Slovenian: Poročila za CAP iz EGP Poročila za CAP izven EGP Poročila za neCAP iz EGP Poročila za neCAP izven EGP
English: At any stage in their development of a medicine, a company can request scientific advice on how best to conduct the various trials and studies that are necessary to demonstrate the quality, safety and efficacy of their product, and thus improve their chances of obtaining a marketing authorisation for it.
Slovenian: Podjetje lahko na vsaki stopnji razvoja zdravila prosi za znanstveno svetovanje o najboljšem načinu izvedbe različnih preskušanj in študij, ki so potrebne za dokaz kakovosti, varnosti in učinkovitosti zdravila, ter s tem poveča možnosti odobritve dovoljenja za promet z zdravilom.
English: Evaluating medicines for human use Record number of positive opinions adopted for new human medicines
Slovenian: Vrednotenje zdravil za uporabo v humani medicini Rekordno število sprejetih pozitivnih mnenj za nova zdravila za uporabo v humani medicini
English: made 1 positive recommendation on extending the use of a medicine authorised for use in adults to use in children, based on clinical-trial data generated in accordance with an agreed PIP.
Slovenian: izdal 1 pozitivno priporočilo o razširitvi uporabe zdravila, ki je odobreno za uporabo pri odraslih, na uporabo pri otrocih zaradi rezultatov kliničnih preskušanj, ki so bili pridobljeni skladno z dogovorjenim načrtom pediatričnih raziskav.
English: The establishment of the CAT was stipulated in the EU's Advanced Therapies Regulation9 - a new and important piece of legislation that introduces special procedures for the evaluation and authorisation of ‘advanced therapy medicinal products' - medicines derived from gene therapy, somatic cell therapy or tissue engineering - which offer groundbreaking treatment options for patients.
Slovenian: Ustanovitev Odbora za napredno zdravljenje določa Uredba EU o naprednem zdravljenju9, nov in pomemben del zakonodaje, ki uvaja posebne postopke za oceno in odobritev „zdravil za napredno zdravljenje“ - zdravil, pridobljenih z gensko terapijo, terapijo s somatskimi celicami ali tkivnim inženirstvom -, ki bolnikom omogočajo najnovejše možnosti zdravljenja.
English: Four were line-extension applications.
Slovenian: Štiri vloge so bile za razširitev indikacij.
English: Healthcare professionals, patients and other consumers of medicines are key stakeholders in the work of the Agency because, besides being the primary end-users of the medicines and information about medicines for which the Agency is responsible, they have specific knowledge and expertise to offer the Agency in return.
Slovenian: Zdravstveni delavci, bolniki in drugi potrošniki zdravil so ključne interesne skupine v delu Agencije, ker so primarni končni uporabniki zdravil in informacij o zdravilih, za katere je odgovorna Agencija.
English: more positive opinions on orphan designation were given in respect of cancer medicines than any other type of medicines;
Slovenian: bilo za zdravila proti raku izdanih več pozitivnih mnenj kot za vsa ostala zdravila;
English: Initial-evaluation applications relate to new medicines that have not previously been authorised in any form in the European Union.
Slovenian: Vloge za začetno oceno se nanašajo na nova zdravila, ki prej v nobeni obliki niso bila odobrena v Evropski uniji.
English: As a result, 66 new medicines - including ones for the prevention or treatment of serious and debilitating conditions such as bone cancer in children, immune-system diseases, HIV and rheumatoid arthritis - will become available to European citizens.
Slovenian: Zaradi tega bo Evropejcem na voljo 66 novih zdravil - vključno z zdravili za preprečevanje ali zdravljenje resnih in izčrpavajočih bolezni, kot so kostni rak pri otrocih, bolezni imunskega sistema, okužbe z virusom HIV in revmatoidni artritis.
English: Companies intending to submit a marketing-authorisation application for a medicine they are developing for use in children or adolescents must first submit a paediatric investigation plan (PIP), setting out the studies they will conduct to demonstrate the quality, safety and efficacy of their medicine when used in these populations.
Slovenian: Družbe, ki nameravajo predložiti vlogo za odobritev dovoljenja za promet za zdravilo, ki ga razvijajo za uporabo pri otrocih ali mladostnikih, morajo najprej predložiti načrt pediatričnih raziskav, v katerem predstavijo študije, ki jih bodo izvedli za dokaz kakovosti, varnosti in učinkovitosti svojih zdravil pri uporabi v omenjenih populacijah.
English: preparing and releasing for consultation a policy on appropriate levels of access by regulatory authorities, healthcare professionals, patients, pharmaceutical industry and the general public to information contained in EudraVigilance - the EU's database of adverse reactions to medicines;
Slovenian: priprava politike o primernih ravneh dostopa regulativnih organov, zdravstvenih strokovnjakov, bolnikov, farmacevtske industrije in splošne javnosti do informacij v sistemu EudraVigilance, zbirke podatkov EU o neželenih učinkih zdravil, in posvetovanje o njej;
English: 1 procedure resulted in the first-ever positive opinion from the CHMP on changing the classification of an authorised medicine from ‘prescription only' to ‘non-prescription'.
Slovenian: je bil 1 postopek, ki se je prvič končal s pozitivnim mnenjem CHMP za spremembo razvrstitve odobrenega zdravila iz „samo na recept“ v „brez recepta“.
English: received 271 applications for PIPs;
Slovenian: prejel 271 vlog za načrt pediatričnih raziskav;
English: Type-II (quality) variations
Slovenian: Spremembe tipa II (kakovost)
English: adopted 48 opinions on applications for product-specific waivers;
Slovenian: sprejel 48 mnenj o vlogah za opustitev, specifičnih za zdravilo;
English: In 2008, the total number of post-authorisation procedures finalised was 2,157, or some 13% higher than in the previous year.
Slovenian: V letu 2008 je bilo skupno število postopkov po izdaji dovoljenja za promet z zdravilom 2 157 ali približno 13 % več kot prejšnje leto.
English: Evaluating medicines for veterinary use Thirteen positive opinions adopted for new veterinary medicines
Slovenian: Vrednotenje zdravil za uporabo v veterinarski medicini Trinajst pozitivnih mnenj za nova zdravila za uporabo v veterinarski medicini
English: One draft entry was released for public consultation.
Slovenian: v javno razpravo dal en osnutek vnosa.
English: To be eligible for these incentives, the company must first submit an application to the Agency, which, through its Committee for Orphan Medicinal Products (COMP), assesses whether or not the medicine should be designated as an orphan medicine.
Slovenian: Pogoji za omenjene spodbude so, da mora družba najprej predložiti vlogo Agenciji, ki prek Odbora za zdravila sirote oceni, ali se lahko zdravilo določi kot zdravilo sirota.
English: Holders of marketing authorisations for medicines that are already approved for use in adults can apply for a paediatric-use marketing authorisation (PUMA) if they wish their medicine to be approved for use in children or adolescents.
Slovenian: Imetniki dovoljenj za promet za zdravila, ki so že odobrena za uporabo pri odraslih, lahko zaprosijo za odobritev dovoljenja za promet z zdravili za uporabo v pediatriji, če želijo da je njihovo zdravilo odobreno za uporabo pri otrocih in mladostnikih.
English: Monitoring the safety of medicines Reporting in EudraVigilance
Slovenian: Spremljanje varnosti zdravil Poročanje v sistemu EudraVigilance
English: designed to provide convenient access to the main regulatory and procedural guidance documents relevant to the operation of the centralised authorisation procedure; creation of a ‘Medicines for the elderly' section of the Agency's public website 13, dedicated to providing information on the work the Agency is conducting with its partners to develop harmonised standards for the development, testing, approval and use of medicines for the elderly.
Slovenian: , ki omogoča prikladen dostop do glavnih dokumentov z regulativnimi in postopkovnimi smernicami, ki zadevajo potek postopka pridobitve dovoljenja za promet po centraliziranem postopku; pripravo razdelka „Zdravila za starostnike“ na spletni strani Agencije13, ki je namenjen zagotavljanju podatkov o delu Agencije s partnerji pri razvijanju usklajenih standardov za razvoj, preskušanje, odobritev in uporabo zdravil za starostnike.
English: These reports cover all adverse reactions (unwanted side-effects) that have been observed, whether within the European Economic Area (EEA)6 or elsewhere in the world, and concern both centrally authorised7 and non-centrally authorised medicines (shown as ‘CAP' and ‘non-CAP', respectively, in the chart below).
Slovenian: Ta poročila obsegajo vse neželene učinke (stranske učinke), ki so bili opaženi v Evropskem gospodarskem prostoru (EGP)6 ali drugje po svetu, in zadevajo tako zdravila, za katera je bilo izdano dovoljenje po centraliziranem postopku7 (v preglednicah prikazana kot „CAP“), ter zdravila, za katera ni bilo izdano dovoljenje po centraliziranem postopku (v preglednicah prikazana kot „neCAP“).
English: A special form of scientific advice, called protocol assistance, can be provided to help developers of orphan-designated medicines demonstrate that their medicine offers a significant benefit over other available treatments, which is a necessary condition for receiving a marketing authorisation for an orphan medicine.
Slovenian: Izdelovalcem zdravil, ki so določena kot zdravila sirote, se lahko zagotovi posebna oblika znanstvenega svetovanja, ki ga imenujemo pomoč pri protokolu, za dokaz, da zdravilo kaže bistveno več koristi od drugih razpoložljivih načinov zdravljenja, kar je nujen pogoj za odobritev dovoljenja za promet z zdravilom siroto.
English: The Agency's total revenue in 2008 was 182,895,000 euro - slightly over 10% higher than in 2007.
Slovenian: V letu 2008 so bili skupni prihodki Agencije 182 895 000 EUR - malo več kot za 10 % višji kot v letu V spodnji preglednici so razčlenjeni prihodki Agencije za leti 2007 in 2008 ter ocene za leto 2009.
English: released for public consultation 14 draft Community herbal monographs for traditional and wellestablished herbal medicines;
Slovenian: v javno razpravo dal 14 osnutkov monografij rastlin Skupnosti za tradicionalna in dobro uveljavljena zdravila rastlinskega izvora;
English: a medicine for use in adults with long-term immune thrombocytopenic purpura, a rare disease in which the patient's immune system destroys the blood platelets that help blood to clot whenever the person bleeds.
Slovenian: Zdravilo, ki se uporablja pri odraslih bolnikih z dolgotrajno imunsko trombocitopenično purpuro, redko boleznijo, pri kateri bolnikov imunski sistem uničuje trombocite, ki sodelujejo pri strjevanju krvi pri vsaki krvavitvi.
English: Applications relating to medicines for use against cancers, infectious diseases, metabolic diseases or alimentary-tract diseases were proportionally higher than ones relating to medicines for any other therapeutic use.
Slovenian: Vlog, ki so se nanašale na zdravila proti raku, nalezljivim boleznim, presnovnim boleznim ali boleznim prebavil, je bilo več kot tistih za zdravila za drugačno terapevtsko rabo.
English: the first medicine for use as maintenance treatment in adults with acute myeloid leukaemia (a type of cancer affecting the white blood cells), in combination with interleukin-2 (an anticancer medicine).
Slovenian: Prvo zdravilo za uporabo kot vzdrževalno zdravljenje pri odraslih z akutno mieloidno levkemijo (vrsto raka, ki prizadene levkocite) v kombinaciji z interlevkinom 2 (zdravilom proti raku).
English: In 2008, a total of 459,485 reports of adverse drug reactions (ADRs) associated with the use of medicines in humans were entered into EudraVigilance.
Slovenian: V letu 2008 je bilo v sistem EudraVigilance vnesenih skupno 459 485 poročil o neželenih učinkih zdravil, ki so bili povezani z uporabo zdravil pri ljudeh.
English: Assessment work in relation to paediatric medicines, rare-disease medicines, herbal medicines and veterinary medicines was intensive in 2008 too, while the volume of work in relation to the provision of scientific advice, the drafting of guidelines, the processing of variation applications and the conduct of pharmacovigilance activities was reasonably high overall.
Slovenian: V letu 2008 je intenzivno potekalo tudi ocenjevanje zdravil za otroke in redke bolezni, zdravil rastlinskega izvora in veterinarskih zdravil, precej dela pa je bilo tudi s podajanjem znanstvenih mnenj, pripravo smernic, obdelavo vlog za spremembe dovoljenj za promet in farmakovigilančnimi dejavnostmi.
English: a medicine to treat hyperphenylalaninaemia (high levels of phenylalanine in the blood) in patients with the genetic disorders phenylketonuria or tetrahydrobiopterin deficiency.
Slovenian: Zdravilo za zdravljenje hiperfenilalaninemije (visokih ravni fenilalanina v krvi) pri bolnikih z gensko boleznijo fenilketonurijo ali pomanjkljivostjo tetrahidrobiopterina.
English: Establishing scientific opinions on herbal medicines
Slovenian: Izdaja znanstvenih mnenj o zdravilih rastlinskega izvora
English: 7 related to medicines for the treatment of a variety of conditions in dogs, including pain, tumours and musculo-skeletal disorders;
Slovenian: 7 mnenj za zdravila za zdravljenje različnih bolezni pri psih, vključno z bolečinami, tumorji in boleznimi mišic in kosti;
English: This project will include consultation with the Agency's primary audiences, including patients, healthcare professionals, regulatory authorities and pharmaceutical companies, and is scheduled to deliver a new website by the end of 2009.
Slovenian: Ta projekt bo vključeval posvetovanje s primarnim občinstvom Agencije, vključno z bolniki, zdravstvenimi strokovnjaki, regulativnimi organi in farmacevtskimi družbami.
English: an anti-rheumatic biological agent (interleukin-6 receptor antagonist) that can be used in combination with methotrexate to treat adults with moderate to severe active rheumatoid arthritis (an immune disease causing inflammation of the joints).
Slovenian: Protirevmatsko biološko zdravilo (antagonist receptorja interlevkina 6), ki se uporablja v kombinaciji z metotreksatom za zdravljenje odraslih bolnikov z zmernim do resnim aktivnim revmatoidnim artritisom (imunsko boleznijo, ki povzroča vnetje sklepov).
English: Initial-evaluation procedures relate to applications for new medicines that have not previously been authorised in the European Union.
Slovenian: Postopki za začetno oceno se nanašajo na vloge za odobritev novih zdravil, ki prej niso bila odobrena v Evropski uniji.
English: a medicine to treat high-grade, non-metastatic osteosarcoma (a rare bone cancer) in children, adolescents and young adults.
Slovenian: Zdravilo za zdravljenje osteosarkoma (redkega kostnega raka) z visoko stopnjo in brez zasevkov pri otrocih, mladostnikih in mladih odraslih.
English: 1 related to a vaccine for the prevention of West Nile Virus in horses and ponies; 1 related to a medicine to combat porcine circovirus in pigs;
Slovenian: 1 mnenje za cepivo za preprečevanje okužbe z zahodnonilskim virusom pri konjih in ponijih; 1 mnenje za zdravilo proti cirkovirusu pri prašičih;
English: Positive opinions Applications withdrawn prior to opinion Negative opinions
Slovenian: Pozitivna mnenjaVloge, umaknjene pred mnenjem Negativna mnenja
English: Type-I variations relate to minor changes to the marketing authorisation for a medicine, such as a change in the name of the medicine, change of the marketing-authorisation holder's or manufacturer's name or address, minor changes to the components of the medicine or their manufacturing processes, or minor changes to the packaging materials.
Slovenian: Spremembe tipa I se nanašajo na manjše spremembe dovoljenja za promet z zdravilom, kot so sprememba imena zdravila, sprememba imetnika dovoljenja za promet ali imena oz. naslova izdelovalca, manjše spremembe sestavin zdravila ali njihovega proizvodnega postopka ali manjše spremembe materialov ovojnine.
English: two medicines used to prevent the formation of venous thromboembolism (blood clots in the veins), which can be administered orally and therefore provide an alternative to conventional therapy by injection.
Slovenian: Dve zdravili za preprečevanje nastanka venske tromboembolije (krvnih strdkov v venah), ki se dajeta peroralno in sta zato alternativi običajnemu zdravljenju z injiciranjem.
English: In 2008, the Agency's Committee for Medicinal Products for Human Use (CHMP) adopted 66 positive opinions1 - the highest number ever adopted in a single year - following its completion of initialevaluation procedures2 for new medicines for human use.
Slovenian: V letu 2008 je Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji po zaključku postopkov za začetno oceno1 novih zdravil za uporabo v humani medicini sprejel 66 pozitivnih mnenj2
English: Number of initial-evaluation applications received for veterinary medicines remains stable
Slovenian: Število vlog za začetno oceno zdravil za uporabo v veterinarski medicini ostaja stabilno
English: Besides monitoring adverse-reaction reports, the Agency also reviews periodic safety update reports that marketing-authorisations holders are obliged to submit in respect of their centrally authorised medicines.
Slovenian: Agencija poleg spremljanja poročil o neželenih učinkih pregleduje tudi periodična poročila o varnosti zdravila, ki jih morajo imetniki dovoljenj za promet z zdravilom predlagati v zvezi z zdravili, za katera
English: a medicine for the treatment of adults who cannot have a bone-marrow transplant and suffer from myelodysplastic syndromes (conditions where the bone marrow produces too few blood cells).
Slovenian: Zdravilo za zdravljenje odraslih bolnikov, katerim ni možno presaditi kostnega mozga in imajo mielodisplastične sindrome (bolezni, pri katerih v kostnem mozgu nastaja premalo krvnih celic).
English: Initial-evaluation applications received, by type of application
Slovenian: Prejete vloge za začetno oceno, po vrsti vloge
English: A total of 104 applications for post-authorisation evaluation of veterinary medicines were received in 2008 - just slightly fewer than the 109 received in 2007.
Slovenian: V letu 2008 smo prejeli skupno 104 vloge za oceno zdravil za uporabo v veterinarski medicini po izdaji dovoljenja za promet - nekoliko manj kot v letu 2007, ko je bilo prejetih 109 vlog.
English: A total of 2,246 applications relating to post-authorisation activities concerning medicines for human use were received in 2008 - a 10% increase on the number received in the previous year.
Slovenian: V letu 2008 smo prejeli skupno 2 246 vlog za dejavnosti po izdaji dovoljenja za promet za zdravila za uporabo v humani medicini - 10 % več kot v predhodnem letu.
English: preparing and releasing for consultation a policy on access to documents, which foresees the ability for the public to request access to any document produced or received and held by the Agency;
Slovenian: Politika predvideva možnost, da javnost zahteva dostop do katerega koli dokumenta, ki nastane v Agenciji ali ga Agencija prejme in hrani;
English: The number of positive opinions adopted on marketing-authorisation applications for medicines for human use was higher than in any year to date.
Slovenian: V tem letu je bilo število pozitivnih mnenj o vlogah za odobritev dovoljenja za promet z zdravilom za uporabo v humani medicini največje doslej.