natgillin/translations-raw huggingface dataset:
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.
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.
more positive opinions on orphan designation were given in respect of cancer medicines than any other type of medicines;
bilo za zdravila proti raku izdanih več pozitivnih mnenj kot za vsa ostala zdravila;
Initial-evaluation applications relate to new medicines that have not previously been authorised in any form in the European Union.
Vloge za začetno oceno se nanašajo na nova zdravila, ki prej v nobeni obliki niso bila odobrena v Evropski uniji.
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.
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.
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.
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.
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;
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;
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'.
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“.
received 271 applications for PIPs;
prejel 271 vlog za načrt pediatričnih raziskav;
Type-II (quality) variations
Spremembe tipa II (kakovost)
adopted 48 opinions on applications for product-specific waivers;
sprejel 48 mnenj o vlogah za opustitev, specifičnih za zdravilo;
In 2008, the total number of post-authorisation procedures finalised was 2,157, or some 13% higher than in the previous year.
V letu 2008 je bilo skupno število postopkov po izdaji dovoljenja za promet z zdravilom 2 157 ali približno 13 % več kot prejšnje leto.
Evaluating medicines for veterinary use Thirteen positive opinions adopted for new veterinary medicines
Vrednotenje zdravil za uporabo v veterinarski medicini Trinajst pozitivnih mnenj za nova zdravila za uporabo v veterinarski medicini
One draft entry was released for public consultation.
v javno razpravo dal en osnutek vnosa.
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.
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.
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.
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.
Monitoring the safety of medicines Reporting in EudraVigilance
Spremljanje varnosti zdravil Poročanje v sistemu EudraVigilance
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.
, 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.
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).
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“).
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.
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.
The Agency's total revenue in 2008 was 182,895,000 euro - slightly over 10% higher than in 2007.
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.
released for public consultation 14 draft Community herbal monographs for traditional and wellestablished herbal medicines;
v javno razpravo dal 14 osnutkov monografij rastlin Skupnosti za tradicionalna in dobro uveljavljena zdravila rastlinskega izvora;
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.
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.
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.
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.
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).
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).
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.
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.
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.
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.
a medicine to treat hyperphenylalaninaemia (high levels of phenylalanine in the blood) in patients with the genetic disorders phenylketonuria or tetrahydrobiopterin deficiency.
Zdravilo za zdravljenje hiperfenilalaninemije (visokih ravni fenilalanina v krvi) pri bolnikih z gensko boleznijo fenilketonurijo ali pomanjkljivostjo tetrahidrobiopterina.
Establishing scientific opinions on herbal medicines
Izdaja znanstvenih mnenj o zdravilih rastlinskega izvora
7 related to medicines for the treatment of a variety of conditions in dogs, including pain, tumours and musculo-skeletal disorders;
7 mnenj za zdravila za zdravljenje različnih bolezni pri psih, vključno z bolečinami, tumorji in boleznimi mišic in kosti;
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.
Ta projekt bo vključeval posvetovanje s primarnim občinstvom Agencije, vključno z bolniki, zdravstvenimi strokovnjaki, regulativnimi organi in farmacevtskimi družbami.
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).
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).
Initial-evaluation procedures relate to applications for new medicines that have not previously been authorised in the European Union.
Postopki za začetno oceno se nanašajo na vloge za odobritev novih zdravil, ki prej niso bila odobrena v Evropski uniji.
a medicine to treat high-grade, non-metastatic osteosarcoma (a rare bone cancer) in children, adolescents and young adults.
Zdravilo za zdravljenje osteosarkoma (redkega kostnega raka) z visoko stopnjo in brez zasevkov pri otrocih, mladostnikih in mladih odraslih.
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;
1 mnenje za cepivo za preprečevanje okužbe z zahodnonilskim virusom pri konjih in ponijih; 1 mnenje za zdravilo proti cirkovirusu pri prašičih;
Positive opinions Applications withdrawn prior to opinion Negative opinions
Pozitivna mnenjaVloge, umaknjene pred mnenjem Negativna mnenja
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.
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.
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.
Dve zdravili za preprečevanje nastanka venske tromboembolije (krvnih strdkov v venah), ki se dajeta peroralno in sta zato alternativi običajnemu zdravljenju z injiciranjem.
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.
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
Number of initial-evaluation applications received for veterinary medicines remains stable
Število vlog za začetno oceno zdravil za uporabo v veterinarski medicini ostaja stabilno
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.
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
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).
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).
Initial-evaluation applications received, by type of application
Prejete vloge za začetno oceno, po vrsti vloge
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.
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.
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.
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.
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;
Politika predvideva možnost, da javnost zahteva dostop do katerega koli dokumenta, ki nastane v Agenciji ali ga Agencija prejme in hrani;
The number of positive opinions adopted on marketing-authorisation applications for medicines for human use was higher than in any year to date.
V tem letu je bilo število pozitivnih mnenj o vlogah za odobritev dovoljenja za promet z zdravilom za uporabo v humani medicini največje doslej.
Type-II variations relate to major changes to the marketing authorisation for a medicine, such as a change in the medicine's indication (the type of disease or condition it can be used to treat), or a substantial change to the packaging or to the information that accompanies the medicine.
Spremembe tipa II se nanašajo na večje spremembe dovoljenja za promet z zdravilom, kot so sprememba indikacije zdravila (vrste bolezni ali stanja, za katerega se lahko uporablja), bistvena sprememba ovojnine ali informacij, ki so priložene zdravilu.
Alternatively, if their medicine is not intended for paediatric use, they must apply for a waiver from the obligation to submit a PIP.
Kadar zdravilo ni namenjeno za uporabo v pediatriji, pa mora družba zaprositi za opustitev obveznosti predložitve načrta pediatričnih raziskav.
Orphan medicinal product designation procedures (2006-2008)
Postopki za določitev zdravila sirote (2006-2008)
Line-extension applications relate to changes to the active substance(s), strength, pharmaceutical form (e.g. powder, ointment or tablet) or route of administration (e.g. oral, intravenous or subcutaneous) of an authorised medicine.
Vloge za razširitev se nanašajo na spremembe zdravilne učinkovine (zdravilnih učinkovin), jakosti, farmacevtske oblike (npr. prašek, mazilo ali tablete) ali poti uporabe zdravila (npr. peroralno, intravensko ali podkožno) za odobreno zdravilo.
1 related to a medicine for the treatment of bovine mastitis in bovines.
1 mnenje za zdravilo za zdravljenje mastitisa pri govedu.
1 related to a painkiller for use in dogs and cats;
1 mnenje za zdravilo proti bolečinam za uporabo pri psih in mačkah;
Volume of post-authorisation procedures initiated for veterinary medicines remains stable
Delež postopkov po izdaji dovoljenja za promet, sproženih za zdravila za uporabo v veterinarski medicini, ostaja stabilen
Positive opinions Negative opinions Application withdrawals
Pozitivna mnenja Negativna mnenja Umiki
Applications for approval of PIPs, waivers and PUMAs are assessed by the Agency's Paediatric Committee, which also conducts compliance-checks to verify that companies applying for a marketing authorisation have developed their medicine in accordance with their approved PIP.
Vloge za odobritev načrta pediatričnih raziskav, opustitev in dovoljenja za promet z zdravili za uporabo v pediatriji vrednoti Odbor za pediatrijo pri Agenciji, ki tudi preverja, ali je družba, ki je predložila vlogo za odobritev, zdravilo razvila skladno z odobrenim načrtom pediatričnih raziskav.
Outcome of initial-evaluation applications (2006-2008)
Izidi vlog za začetno oceno (2006-2008)
1 related to a painkiller/anti-inflammatory for use in horses;
1 mnenje za zdravilo proti bolečinam/vnetju za uporabo pri konjih;
Volume of post-authorisation procedures finalised for human medicines increased by 13%
Delež postopkov po izdaji dovoljenja za promet, zaključenih za zdravila za uporabo v humani medicini, se je povečal za 13 %
Number of initial-evaluation applications for human medicines up by 14%
Za 14 % več vlog za začetno oceno zdravil za uporabo v humani medicini
Fees
Ciper
New medicinal products (non-orphan) Orphan medicinal products Similar biological products
Nova zdravila (brez sirot)
The volume of applications received by the Agency in 2008 for initial evaluation of new veterinary medicines was, at 16 applications, similar to the volume seen in 2007.
Agenciji je bilo v letu 2008 predloženih 16 vlog za začetno oceno novih zdravil za uporabo v veterinarski medicini, kar je podobno številu prejetih vlog v letu 2007.
1 related to a medicine for the treatment of respiratory disease in cattle;
1 mnenje za zdravilo za zdravljenje bolezni dihal pri govedu;
The number of initial-evaluation applications submitted to the Agency in 2008 for evaluation of new medicines for use in humans was 103 - a 14% increase on the number received in 2007.
Agenciji so bile v letu 2008 predložene 103 vloge za začetno oceno novih zdravil za uporabo v humani medicini, kar predstavlja 14-odstotno zvišanje glede na število prejetih vlog v letu 2007.
Volume of post-authorisation procedures initiated for human medicines increased by 10%
Delež postopkov po izdaji dovoljenja za promet, sproženih za zdravila za uporabo v humani medicini, se je povečal za 10 %
Type-I variations Type-II variations Extensions
Spremembe tipa I Spremembe tipa II
finalised a record number of 328 scientific-advice and protocol-assistance requests relating to medicines for human use (up 14% on the number of requests finalised in 2007);
zaključila rekordno število 328 zahtevkov za znanstveno svetovanje in pomoč pri protokolu v zvezi z zdravili za uporabo v humani medicini (za 14 % več kot je bilo zaključenih zahtevkov v letu prejela 320 novih ali naknadnih zahtevkov za znanstveno svetovanje ali pomoč pri protokolu v zvezi z zdravili za uporabo v humani medicini;
5 The ‘Community list…' is an official list, established by the HMPC and approved by the European Commission, of herbal substances and preparations that have been in medicinal use for a sufficiently long time, and which are therefore considered not to be harmful under normal conditions of use.
Vsebuje rastlinske snovi in pripravke, ki so bili v medicinski rabi dovolj dolgo in štejejo kot neškodljivi v običajnih pogojih uporabe.
Applications for new medicinal products Generic applications
Vloge za generična zdravila
adopted 35 decisions on class waivers3;
(Klinične) spremembe tipa II Razširitve sprejel 35 odločitev o skupinskih opustitvah3;
The next few pages provide brief highlights of the Agency's activities in each of its priority areas for the year, together with key figures to demonstrate the volume and evolution of its core scientific and regulatory procedures.
Dodane so ključne številke za prikaz obsega in razvoja njenih osrednjih strokovnih in regulativnih postopkov.
Type-IA variations
Spremembe tipa IA
The number of initial-evaluation procedures finalised by the Agency in relation to veterinary medicines in 2008 was 13.
V letu 2008 je Agencija dokončala 13 postopkov za začetno oceno zdravil za uporabo v veterinarski medicini.
EEA and non-EEA ADR reports received (2006-2008)
Prejeta poročila o neželenih učinkih zdravil iz EGP in izven EGP (2006-2008)
launch of the ENCePP website11, devoted to the activities of the newly created European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), which is coordinated by the Agency; creation of a new ‘Regulatory and procedural guidelines' section12 of the Agency's public website,
Do takrat pa se je komunikacija Agencije prek spleta med letom stalno izboljševala, vključno z: zagonom spletne strani ENCePP11, namenjene dejavnostim novo ustanovljene Evropske mreže centrov za farmakoepidemiologijo in farmakovigilanco, ki jo usklajuje Agencija;
Efforts made in 2008 to further enhance the involvement of healthcare professionals, patients and consumers in the Agency's activities included: extending the scope of patients' and consumers' involvement in reviewing the quality of package leaflets (the information contained in the package of a medicine); working with patients and consumers to establish, by means of a survey, their level of satisfaction with their current involvement in the activities of the Agency; integrating input received from healthcare professionals, patients and consumers in the development of the Agency's communications strategy.
delo z bolniki in potrošniki, da bi z anketo ugotovili zadovoljstvo s trenutnim sodelovanjem pri dejavnostih Agencije;
Post-authorisation applications received (2006-2008)
Prejete vloge za postopke po izdaji dovoljenja za promet (2006-2008)
4 A herbal monograph is a collection of all relevant information concerning a herbal medicine, including its composition, use, safety precautions, etc.
Monografija rastlin je zbirka vseh pomembnih informacij o zdravilu rastlinskega izvora, vključno z njegovo sestavo, uporabo, varnostnih ukrepih itn. „Seznam rastlinskih snovi Skupnosti …“ je uradni seznam, ki ga uveljavil HMPC, odobrila pa Evropska komisija.