FrancophonIA/ELRC3.0 huggingface dataset:
English: The number of scientific-advice requests was slightly higher than in 2006, with 213 requests received in 2007.
Slovenian: Število zahtevkov za znanstveno svetovanje je bilo rahlo večje kot v letu 2006; v letu 2007 je bilo prejetih 213 zahtevkov.
English: 2.1 Orphan medicines Increase in applications and opinions
Slovenian: 2.1 Zdravila sirote Povečanje števila vlog in mnenj
English: The number of applications for variations and line extensions of marketing authorisations continued to rise.
Slovenian: Število vlog za spremembe in razširitev linij za dovoljenja za promet z zdravilom se je še naprej povečevalo.
English: The CHMP adopted 18 classification reports, drafted by the ITF, describing the scientific and regulatory criteria for the definition of a medicinal product.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je sprejel 18 razvrstitvenih poročil, ki jih je sestavila ITF in ki opisujejo znanstvena in regulativna merila za opredelitev medicinskega izdelka.
English: Consultation on the experience with the directive on herbal medicines
Slovenian: Posvetovanje o izkušnjah z direktivo o zdravilih rastlinskega izvora
English: The number for human medicines is higher than in any previous year, and the number of opinions adopted by the Agency's Committee for Medicinal Products for Human Use (CHMP), at 65, was also the highest ever recorded.
Slovenian: Število vlog za zdravila za uporabo v humani medicini je večje kot vsa leta doslej, in tudi število mnenj, ki jih je sprejel Odbor za zdravila za uporabo v humani medicini Agencije (CHMP), je s 65 vlogami največje, kar smo ga imeli doslej.
English: Topics covered included gene-therapy medicines, diagnostics, oncology development, new approaches to quality assessment, and pandemic influenza.
Slovenian: Obravnavane teme so vključevale zdravila za gensko zdravljenje, diagnostiko, razvoj onkologije, nove pristope k oceni kakovosti in pandemično gripo.
English: 1.6 The European medicines network
Slovenian: 1.6 Evropska mreža zdravil
English: In this, the thirteenth year of its operation, the EMEA delivered a strong performance in its core activity areas relating to the evaluation and supervision of medicines, while also pursuing with good results its broader mandate to stimulate innovation within the EU and contribute to European and global cooperation on scientific and regulatory practices in the field of medicines.
Slovenian: V tem trinajstem letu delovanja je EMEA naredila veliko na temeljnih področjih svojega delovanja, povezanih z vrednotenjem zdravil in nadzorom nad njimi, hkrati pa je z dobrimi rezultati sledila tudi svojemu širšemu poslanstvu, tj. spodbujanju inovacij znotraj EU ter prispevanju k evropskemu in svetovnemu sodelovanju pri znanstvenih in regulativnih praksah v medicini.
English: Bluetongue is an insect-borne disease of domestic ruminants, principally sheep, whose geographical range has now spread to include much of the EU.
Slovenian: Bolezen modrikastega jezika prenašajo žuželke, prizadene pa domače prežvekovalce, predvsem ovce, in se je geografsko tako razširila, da se zdaj pojavlja na večini ozemlja EU.
English: The CVMP adopted a reflection paper on minimum data requirements for authorisation of bluetongue vaccines for emergency use.
Slovenian: CVPM je sprejel preučitveni dokument o najmanjših podatkovnih zahtevah za izdajo dovoljenja za promet s cepivi proti bolezni modrikastega jezika za izjemne razmere.
English: Neurology and the central nervous system were the next mostrepresented therapeutic groups, followed by anti-infectives.
Slovenian: Nevrologija in centralni živčni sistem sta bila naslednji najpogosteje zastopani terapevtski skupini, sledila pa so jima zdravila za zdravljenje okužb.
English: Forty percent of ADR reports received related to centrally authorised medicines.
Slovenian: 40 odstotkov prejetih poročil o ADR se je nanašalo na zdravila, za katera je bilo izdano dovoljenje po centraliziranem postopku.
English: The EMEA issued a decision on a ‘list of class waivers', which includes conditions that do not affect children and for which the requirement to submit a PIP can therefore be waived.
Slovenian: EMEA je izdala sklep o „seznamu opustitev za skupino zdravil“, ki vključuje bolezni, ki ne prizadenejo otrok in za katere je tako mogoče opustiti zahtevo za predložitev načrta pediatrične raziskave.
English: Referral procedures concluded in 2007
Slovenian: Postopki napotitev, končani v letu 2007
English: Interest in the Agency's provision of scientific advice and protocol assistance also continued to be high, with demand increasing for the third year in a row.
Slovenian: Zanimanje za znanstveno svetovanje in pomoč pri protokolu, ki ju ponuja Agencija, je še naprej ostalo veliko, povpraševanje pa se je povečevalo že tretje leto zapored.
English: 2.4 Post-authorisation activities Number of variations up by almost 30%
Slovenian: 2.4 Dejavnosti po izdaji dovoljenja Število sprememb se je povečalo za skoraj 30 %
English: EMEA post-opinion phase
Slovenian: EM EA post-opinion phase
English: Applications for new medicines for use in the treatment of cancer once again represented the highest proportion by therapeutic area in 2007.
Slovenian: Vloge za nova zdravila za uporabo pri zdravljenju raka so imele v letu 2007 znova največji delež glede na terapevtsko področje.
English: Review of generic medicines containing cetirizine, because of concerns over their bioequivalence.
Slovenian: • Presoja generičnih zdravil, ki vsebujejo cetirizin, zaradi zaskrbljenosti v zvezi z njihovo bioekvivalenco.
English: A total of 57 referrals were received in 2007: 40% more than in 2006.
Slovenian: V letu 2007 je bilo skupno prejetih 57 napotitev: to je za 40 % več kot v letu 2006.
English: The development of recommendations of the EMEA/CHMP Working Group with Healthcare Professionals (HCP WG) started in 2007.
Slovenian: Sestavljanje priporočil agencije EMEA/delovne skupine CHMO z delovno skupino zdravstvenega osebja (HCP WG) se je začelo v letu 2007.
English: This document provides a summary of the EMEA annual report for 2007.
Slovenian: Ta dokument je povzetek letnega poročila agencije EMEA za leto 2007.
English: A first version for use by national competent authorities was released in September
Slovenian: Prva različica, namenjena nacionalnim pristojnim organom, je bila izdana septembra 2007.
English: Musculoskeletal and nervous system
Slovenian: M usculoskeletal and nervous system
English: These procedures were operated with increasing effectiveness in 2007, resulting in 4 opinions being adopted following accelerated assessment (relating to 2 medicines for human use and 2 for veterinary use), 3 opinions recommending granting of a conditional marketing authorisation (relating to 3 medicines for human use) and 6 opinions recommending granting of a marketing authorisation under exceptional circumstances (relating to 4 medicines for human use and 2 for veterinary use).
Slovenian: Ti postopki so se v letu 2007 izvajali z rastočo učinkovitostjo, tako da so bila sprejeta štiri mnenja po postopku pospešenega vrednotenja (za dve zdravili za uporabo v humani medicini in dve zdravili za uporabo v veterinarski medicini), tri mnenja, ki priporočajo izdajo pogojnega dovoljenja za promet z zdravilom (za tri zdravila za uporabo v humani medicini) in šest mnenj, ki priporočajo izdajo dovoljenja za promet z zdravilom v izjemnih okoliščinah (za štiri zdravila za uporabo v humani medicini in dve zdravili za uporabo v veterinarski medicini).
English: Piroxicam can still be prescribed for the symptomatic relief of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
Slovenian: Piroksikam je še vedno dovoljeno predpisati za simptomatično lajšanje osteoartritisa, revmatoidnega artritisa in ankilozirajočega spondilitisa.
English: Following the assessment of the corrective and preventive measures put in place by the marketing-authorisation holder and the inspection of the manufacturing site - which provided reassurance that the cause of the contamination had been eliminated and that future production of Viracept would meet the required quality standards - the CHMP subsequently recommended the lifting of the suspension of the marketing authorisation and the re-introduction of the medicine onto the market in the European Union.
Slovenian: Po oceni korektivnih in preventivnih ukrepov, ki jih je uvedel imetnik dovoljenja za promet z zdravilom, in pregledu proizvodnega objekta - kar je dalo zagotovilo, da je bil vzrok onesnaženja odpravljen in da bo proizvodnja zdravila Viracept v prihodnosti ustrezala zahtevanim standardom kakovosti - je CHMP priporočil umik začasne ukinitve dovoljenja za promet z zdravilom in vnovično uvedbo zdravila na trg Evropske unije.
English: The EMEA's cooperation with global partner organisations continued apace in 2007, with the Agency playing an active role in the International Conferences on Harmonisation (ICH and VICH); working closely with the World Health Organization, in particular on issues relating to medicines for developing countries; consolidating its information-exchange programme with the US Food and Drug Administration in relation to human and veterinary medicines; and signing confidentiality arrangements to allow closer cooperation between the EMEA, the European Commission and the Japanese authorities on regulatory issues concerning medicines.
Slovenian: Sodelovanje agencije EMEA s svetovnimi partnerskimi organizacijami se je leta 2007 pospešeno nadaljevalo, pri čemer je Agencija igrala dejavno vlogo na mednarodnih konferencah o harmonizaciji (ICH in VICH), tesno sodelovala s Svetovno zdravstveno organizacijo, še posebno pri temah, ki se nanašajo na zdravila za države v razvoju, utrjevala program za izmenjavo informacij z Uradom za hrano in zdravila iz ZDA (Food and Drug Administration) v zvezi z zdravili za uporabo v humani in veterinarski medicini ter podpisala dogovore o zaupnosti, ki omogočajo tesnejše sodelovanje med agencijo EMEA, Evropsko komisijo in japonskimi organi glede regulativnih vprašanj v zvezi z zdravili.
English: The highest number of positive opinions adopted was for cancer medicines, followed by antiinfectives and alimentary-tract medicines.
Slovenian: Največje število sprejetih pozitivnih mnenj je bilo za zdravila proti raku, sledila pa so mnenja za zdravila za zdravljenje okužb in zdravila za prebavni trakt.
English: New guidance available
Slovenian: Na voljo so nove smernice
English: Accelerated assessment, conditional marketing authorisation and marketing authorisation under exceptional circumstances are special marketing-authorisation procedures aimed at bringing medicines of high public and animal-health interest to the market more quickly.
Slovenian: Pospešeno vrednotenje, pogojna dovoljenja za promet z zdravilom in dovoljenje za promet z zdravilom v izjemnih okoliščinah so posebni postopki za izdajo dovoljenja za promet z zdravilom, katerih cilj je hitrejše uvajanje zdravil, ki so velikega pomena za zdravje ljudi in živali, na trg.
English: The EMEA was a member of the Steering Committee of the European Technology Platform for Global Animal Health, which aims to accelerate the development of novel animal-health products, for both major and minor markets, within the context of the 7th Framework Programme.
Slovenian: Agencija EMEA je bila članica usmerjevalnega odbora evropske tehnološke platforme za globalno zdravje živali, ki na podlagi 7. okvirnega programa poskuša pospešiti razvoj novih izdelkov za zdravje živali za večje in manjše trge.
English: The EudraVigilance DataWarehouse and Analysis System (EVDAS) was rolled out to the national competent authorities on 6 July 2007.
Slovenian: Podatkovno skladišče in sistem za analizo EudraVigilance (EVDAS) je bilo zagotovljeno nacionalnim pristojnim organom 6. julija 2007.
English: 25% more adverse-drug-reaction reports received in 2007
Slovenian: V letu 2007 prejetih 25 % več poročil o neželenih učinkih zdravil
English: Following review of data from recent clinical trials showing consistent unexplained excess mortality in patients with anaemia associated with cancer who had been treated with epoetins, the indication in the treatment of anaemia was restricted to anaemia associated with symptoms.
Slovenian: Po pregledu podatkov iz nedavnih kliničnih preskušanj, ki kažejo na dosledno nerazložljivo povišano smrtnost pri bolnikih z anemijo, povezano z rakom, ki so bili zdravljeni z epoetini, je bila terapevtska indikacija pri zdravljenju anemije omejena na anemijo, povezano s simptomi.
English: A total of 288 scientific-advice, protocol-assistance and follow-up requests were finalised in 2007, compared to 257 in 2006.
Slovenian: V letu 2007 je bilo dokončno obdelanih skupno 288 zahtevkov za znanstveno svetovanje, pomoč pri protokolu in spremljanje, medtem ko smo v letu 2006 dokončno obdelali 257 zahtevkov.
English: Notably, given recent attention paid in the media to the risk of a bird-flu pandemic, two vaccines against avian influenza were made available for use in poultry.
Slovenian: Glede na nedavno pozornost medijev na nevarnost pandemije ptičje gripe je še posebno pomembno, da sta bili na razpolago dani dve cepivi proti aviarni influenzi za uporabo pri perutnini.
English: 1.2 Safety of medicines for human and veterinary use
Slovenian: 1.2 Varnost zdravil za uporabo v humani in veterinarski medicini
English: The CHMP adopted 2 opinions on scientific matters in the context of Article 5(3) procedures: 1 on the adequacy of guidelines on medicines in the context of the elderly, the other on the potential risk of carcinogens, mutagens and substances toxic to reproduction (CMRs) when used as excipients in medicines for human use.
Slovenian: CHMP je sprejel dve mnenji o znanstvenih zadevah na podlagi postopkov iz člena 5(3): eno mnenje o ustreznosti smernic o zdravilih v povezavi s starejšimi osebami, drugo pa o morebitnem tveganju zaradi kancerogenov, mutagenov in snovi, ki so strupene za razmnoževanje (CMR), kadar se uporabljajo kot pomožne snovi v zdravilih za uporabo v humani medicini.
English: Development of EudraVigilance Veterinary (EVV) delayed in 2007
Slovenian: Razvoj zbirke podatkov sistema EudraVigilance za veterinarstvo (EVV) je v letu 2007 v zaostanku
English: The new features include advanced search for product information in a number of EU languages (being tested), a new sitemap offering improved navigation, and the inclusion of maximum residue limit (MRL) information for veterinary medicines.
Slovenian: Nove funkcije vključujejo napredno iskanje podatkov o izdelkih v številnih jezikih EU (v fazi preskušanja), novo kazalo strani, ki omogoča izboljšano krmarjenje, in vključitev podatkov o najvišjih mejnih vrednostih ostankov (MRL) za zdravila za uporabo v veterinarski medicini.
English: For adopted post-authorisation opinions or notifications, the increase was even more pronounced, with a rise of 37% over the previous year.
Slovenian: Pri sprejetih mnenjih in obvestilih po izdaji dovoljenja za promet z zdravilom je bil porast še opaznejši, saj je njihovo število za 37 % večje kot leto poprej.
English: The Committee for Orphan Medicinal Products (COMP) adopted 97 positive opinions on orphan designation - the highest number ever - and 1 negative opinion.
Slovenian: Odbor za zdravila sirote (COMP) je sprejel 97 pozitivnih mnenj o določitvi zdravila kot zdravila sirote - to je do zdaj najvišje število - in eno negativno mnenje.
English: Following resumption of activity on EVV, the Agency and the Veterinary Joint Implementation Group developed the EudraVigilance Veterinary Action Plan, which was endorsed by the EMEA Management Board and the Heads of Medicines Agencies.
Slovenian: Po nadaljevanju dela z EVV sta Agencija in Veterinarska skupina za skupno izvajanje (Veterinary Joint Implementation Group) razvili Veterinarski akcijski načrt sistema EudraVigilance, ki so ga podprli upravni odbor agencije EMEA in vodje agencij za zdravila.
English: There were 9 applications for extension of marketing authorisation.
Slovenian: Prejeli smo devet vlog za razširitev dovoljenja za promet z zdravilom.
English: Of these, 90% and 86% related to line-extension and extension-of-indication applications respectively.
Slovenian: Od teh se jih je 90 % nanašalo na vloge za razširitev linije, 86 % pa na vloge za razširitev terapevtskih indikacij.
English: Likewise, innovation and availability remained high priorities in the veterinary area, with input being given from the Agency to the Heads of Medicines Agencies (HMA) action plan to promote the availability of veterinary medicines and to the European Technology Platform for Global Animal Health, as well as to the further development of measures to assist companies seeking to authorise medicines for limited markets.
Slovenian: Tudi v veterinarski medicini sta inovativnost in razpoložljivost zdravil ostali pomembni prednostni nalogi, pri čemer je Agencija zagotavljala vhodne podatke za akcijski načrt vodij agencij za zdravila (HMA) za spodbujanje razpoložljivosti veterinarskih zdravil in evropsko tehnološko platformo za globalno zdravje živali (European Technology Platform for Global Animal Health) kot tudi za nadaljnji razvoj ukrepov, ki bodo pomagali podjetjem, ki poskušajo pridobiti dovoljenje za zdravila za omejene trge.
English: There was also a shortfall in the number of applications submitted for extension or modification of MRLs, with only 1 of the forecast 5 being submitted.
Slovenian: Primanjkljaj se kaže tudi pri številu predloženih vlog za razširitev ali spremembo najvišjih vrednosti ostankov, saj je bila od pričakovanih petih predložena samo ena taka vloga.
English: Development of EVV was delayed for a period of some 6 months during 2007, due to re-prioritisation of resources to further develop the EudraVigilance (human) data warehouse.
Slovenian: Razvoj zbirke podatkov sistema Eudravigilance za veterinarstvo je v letu 2007 zaostal za približno šest mesecev, ker smo sredstva preusmerili na drugo prednostno nalogo - nadaljnji razvoj podatkovnega skladišča sistema EudraVigilance (za humano medicino).
English: Almost half of orphan-designated medicines for treatment of children
Slovenian: Skoraj polovica zdravil z oznako zdravila sirote je namenjena za zdravljenje otrok
English: The CVMP adopted 3 positive opinions for the establishment of new MRLs.
Slovenian: CVMP je sprejel tri pozitivna mnenja za določitev novih mejnih vrednosti ostankov.
English: The EMEA received 381,990 adverse-drug-reaction (ADR) reports in 2007 - an increase of more than 25% compared to the previous year.
Slovenian: Agencija EMEA je v letu 2007 prejela 381 990 poročil o neželenih učinkih zdravil (ADR), kar pomeni več kot 25-odstotno povečanje v primerjavi s prejšnjim letom.
English: The Agency received a total of 15 initial marketing-authorisation applications for veterinary medicinal products, 8 of which were for pharmaceutical products and 7 for immunologicals.
Slovenian: Agencija je prejela skupaj 15 začetnih vlog za izdajo dovoljenja za promet z zdravilom za uporabo v veterinarski medicini, od katerih jih je bilo osem za farmacevtske izdelke in sedem za imunološka zdravila.
English: It blocks the activity of renin, an enzyme which is involved in the production of angiotensin I that is subsequently converted into the hormone angiotensin II, a powerful vasoconstrictor (it narrows blood vessels and consequently raises the blood pressure).
Slovenian: Zavira delovanje renina, encima ki sodeluje pri nastajanju angiotenzina I, ki se naknadno spremeni v hormon angiotenzin II, močan vazokonstriktor (oži žile in posledično dvigne krvni tlak).
English: Innovation Task Force: supporting development of advanced-therapy medicines
Slovenian: Projektna skupina za inovacije: podpora razvoju zdravil za napredno zdravljenje
English: Following further investigation, 22% (132) of suspected signals required follow-up for intensively monitored medicines, including involving the rapporteur for 43 signals.
Slovenian: V nadaljevanju preiskave je bilo pri 22 % (132) sumih signalov pri intenzivno spremljanih zdravilih potrebno nadaljnje ukrepanje, pri tem je bilo pri 43 signalih treba vključiti poročevalca.
English: Forty-four orphan-designated medicines authorised for use in the EU
Slovenian: 44 zdravil, določenih kot zdravila sirote, odobrenih za uporabo v EU
English: Similarly, new veterinary prevention and treatment options are now available for Europe's food-producing and companion animals.
Slovenian: Podobno so tudi v veterinarski medicini na voljo nove možnosti za preprečevanje in zdravljenje za evropske živali, namenjene za proizvodnjo hrane, in hišne živali.
English: 1.4 Earlier and improved availability of medicines Special authorisation procedures in operation
Slovenian: 1.4 Zgodnejša in izboljšana dostopnost zdravil Posebni postopki za izdajo dovoljenja za promet z zdravilom potekajo
English: Sixty-six quality defects were successfully coordinated, 22 of which resulted in recalls.
Slovenian: Uspešno usklajenih je bilo 66 pomanjkljivosti glede kakovosti, od katerih je bil pri 22 potreben umik izdelka.
English: 2 vaccines for pigs, against porcine circovirus type 2.
Slovenian: • dve cepivi proti prašičjemu cirkovirusu tipa 2 za prašiče.
English: Two applications were made for medicines that had received free scientific advice under the programme for minor uses and minor species.
Slovenian: Dve vlogi sta bili podani za zdravili, za kateri je bilo zagotovljeno brezplačno znanstveno svetovanje po programu za manjšo uporabo in manj pomembne živalske vrste.
English: The EMEA actively participated in the preparatory steps of the Innovative Medicines Initiative - a public-private partnership between the pharmaceutical industry and the European Communities, which aims to address bottlenecks in the development of medicines.
Slovenian: Agencija EMEA je dejavno sodelovala pri pripravi pobude za inovativna zdravila - javno-zasebnega partnerstva med farmacevtsko industrijo in Evropskimi skupnostmi, katere cilj je spopadanje z ozkimi grli pri razvoju zdravil.
English: The Agency also progressed well with its development and maintenance of informationtechnology services, as well as with its programme to enhance the participation of patients and healthcare professionals in EMEA activities.
Slovenian: Agencija je dobro napredovala tudi pri razvoju in vzdrževanju storitev informacijske tehnologije ter programu za spodbujanje sodelovanja bolnikov in zdravstvenih strokovnjakov v dejavnostih Agencije.
English: A marked increase in the number of requests for protocol assistance was registered, with 17% more requests received than in 2006.
Slovenian: Opaženo je bilo izrazito povečanje števila zahtevkov za pomoč pri protokolu; prejeli smo 17 % več zahtevkov kot v letu 2006.
English: Review of medicines containing 30μg ethinyl estradiol + 2mg chlormadinone acetate, because of differences among Member States on whether the indication of these two medicines should be extended to include the treatment of women suffering from moderate acne.
Slovenian: • Presoja zdravil, ki vsebujejo 30 µg etinil estradiola + 2 mg klormadinon acetata, zaradi razhajanj med državami članicami glede tega, ali bi bilo treba indikacije teh zdravil razširiti, tako da bi vključevale zdravljenje žensk, ki trpijo zaradi zmernih aken.
English: This reflects the increasing number of authorised medicines requiring re-inspection, increasing numbers of variations, and some unanticipated PMF inspections.
Slovenian: To odraža čedalje večje število zdravil z dovoljenjem za promet, za katera je potreben vnovični pregled, rastoče število sprememb in nekaj nepričakovanih inšpekcijskih pregledov glavnega dosjeja plazme.
English: Use of special authorisation procedures: facilitating availability of medicines
Slovenian: Uporaba posebnih postopkov za izdajo dovoljenja za promet z zdravilom: zagotavljanje dostopnosti zdravil