FrancophonIA/ELRC3.0 huggingface dataset:
English: Further progress was made with regard to signal-detection in EudraVigilance through: implementing a new data-analysis system; drafting guidance on the use of statistical signal-detection methods in the data-analysis system; and initiatives undertaken to address identified problems in relation to compliance with expedited reporting and the quality of the submitted data.
Slovenian: Dosežen je bil dodatni napredek pri izvajanju EudraVigilance v zvezi z odkrivanjem signalov prek: izvajanja novega sistema za analiziranje podatkov, priprave smernic o uporabi statističnih metod za odkrivanje signalov v sistemu za analiziranje podatkov in pobud, sproženih za obravnavo opredeljenih težav v zvezi s pospešenim poročanjem in kakovostjo predloženih podatkov.
English: In 2006, the EMEA received and validated 3 new applications for maximum residue limits (MRLs)the same number as in 2005, and 2 fewer than were forecast for the year.
Slovenian: Leta 2006 je EMEA prejela in potrdila tri nove vloge za najvišje mejne vrednosti ostankov (maximum residue limits - MRL), kar je enako kot leta 2005, in dve vlogi manj, kot sta bili predvideni za zadevno leto.
English: Positive opinions
Slovenian: Pozitivna mnenja
English: After consulting its stakeholders, the EMEA put in place procedures to publish information on the withdrawal of applications prior to opinion and on the refusal of marketing authorisations.
Slovenian: EMEA je po posvetovanju z zainteresiranimi stranmi vzpostavila postopke za objavljanje informacij o umiku vlog pred sprejetjem mnenja in zavrnitvi izdaje dovoljenj za promet z zdravilom.
English: EudraVigilance and clinical trials
Slovenian: EudraVigilance in klinična preizkušanja
English: The CHMP concluded that the benefits associated with the use of these dermatological medicinal products outweigh the risks, but that they should be used with greater caution in order to reduce potential risks of skin cancer and lymphoma as far as possible.
Slovenian: CHMP je sklenil, da koristi, povezane z uporabo teh dermatoloških zdravil, prevladajo nad tveganji, vendar je treba izdelke uporabljati previdneje, da se čim bolj zmanjšajo morebitna tveganja za nastanek kožnega raka in limfoma.
English: Six related to safety issues or benefit/risk evaluation, of which 3 were for pharmaceuticals and 3 were for vaccines.
Slovenian: Šest se jih je nanašalo na vprašanja varnosti ali presojo koristi in tveganja, od tega so se tri nanašale na farmacevstke izdelke in tri na cepiva.
English: In the veterinary sphere, the EMEA held a very successful Infoday with IFAH-Europe, in November, at which a number of topics were intensely debated, including benefit-risk assessment, user-safety guidelines and environmental-risk assessment.
Slovenian: Na veterinarskem področju je EMEA novembra organizirala zelo uspešen informativni dan z IFAHEvropa, na katerem so intenzivno razpravljali o številnih temah, vključno z oceno koristi in tveganja, smernicami za varnost potrošnikov in oceno okoljskega tveganja.
English: In order to further progress the direct electronic reporting of adverse reactions into the EudraVigilance Veterinary database, a simplified electronic reporting tool was made available, designed particularly for use by smaller companies in the veterinary industry.
Slovenian: Za dosego nadaljnega napredka pri neposrednem elektronskem poročanju o neželenih učinkih v zbirko veterinarskih podatkov EudraVigilance je bilo dano na voljo poenostavljeno poročevalsko orodje, ki je bilo oblikovano predvsem za uporabo manjših podjetij v veterinarski industriji.
English: Marked increase in expedited reporting of suspected adverse reactions
Slovenian: Opazno povečanje pospešenega poročanja o sumih na neželene učinke
English: Opinions for extrapolations
Slovenian: Mnenja za ekstrapolacije
English: EudraVigilance (web-based information system to support the pharmacovigilance obligations laid down by Community legislation).
Slovenian: EudraVigilance (spletni informacijski sistem za podpiranje obveznosti farmakovigilance, ki jih določa zakonodaja Skupnosti).
English: Use of special authorisation procedures
Slovenian: Uporaba posebnih postopkov za izdajo dovoljenja
English: Preparing for the establishment of the European Network of Centres of Pharmacoepidemiology and Pharmacovigilance (ENCePP) - a network of academic centres for intensive drug monitoring.
Slovenian: Priprave na vzpostavitev evropske mreže centrov za farmakoepidemiologijo in farmakovigilanco (European Network of Centres of Pharmacoepidemiology and Pharmacovigilance - ENCePP)mreže akademskih centrov za intenzivno spremljanje drog.
English: A total of 257 scientific-advice, protocol-assistance and follow-up requests were finalised in 2006, compared to 191 in 2005.
Slovenian: Leta 2006 je bilo zaključenih skupaj 257 zahtevkov za znanstveno svetovanje, pomoč pri protokolu in spremljanje v primerjavi s 191 zahtevki v letu 2005.
English: Negative opinions
Slovenian: Negativna mnenja
English: Opinions adopted in 2006
Slovenian: Mnenja, sprejeta leta 2006
English: The cardiovascular safety of non-selective non-steroidal anti-inflammatory drugs (NSAIDs) stemming from new clinical and pharmacoepidemiological study data.
Slovenian: kardiovaskularne varnosti neselektivnih nesteroidnih protivnetnih zdravil (NSAID), ki izhaja iz novih podatkov iz kliničnih in farmakoepidemioloških študij.
English: The marketing-authorisation holder and the manufacturer are currently undertaking an extensive corrective-action plan to restore GMP compliance at the site of manufacture, and the matter is under close monitoring by the CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom in proizvajalec trenutno izvajata obsežen načrt korektivnega ukrepanja za ponovno vzpostavitev skladnosti z dobro proizvodno prakso na kraju proizvodnje, zadevo pa podrobno spremlja CHMP.
English: The small number of new MRL applications is consistent with the comparatively greater interest currently seen for the development of new veterinary medicines for companion animals than for food-producing animals.
Slovenian: Majhno število novih vlog za najvišje mejne vrednosti ostankov je skladno z razmeroma večjim interesom, ki ga trenutno opazimo za razvoj novih veterinarskih zdravil za hišne živali in ne živali, namenjene proizvodnji hrane.
English: In addition, the Agency made proposals for topics of public-health interest, such as pharmacovigilance, to be included in the project.
Slovenian: Agencija je poleg tega pripravila predloge za teme, ki jih je treba vključiti v projekt in so v interesu javnega zdravja, kot je farmakovigilanca.
English: All applications for new MRLs and for extension or modification of existing MRLs were processed within the 120-day legal timeframe.
Slovenian: Vse vloge za nove najvišje mejne vrednosti ostankov in za razširitev ali spremembo obstoječih najvišjih mejnih vrednosti ostankov so bile obdelane v 120-dnevnem zakonskem obdobju.
English: In 2006, the EMEA received 64 quality-defect reports concerning human medicinal products and 3 quality-defect reports concerning veterinary medicinal products.
Slovenian: EMEA je leta 2006 prejela 64 poročil o pomanjkljivi kakovosti pri zdravilih za uporabo v humani medicini in tri poročila o pomanjkljivostih pri zdravilih za uporabo v veterinarski medicini.
English: Therapeutic areas concerned: cancer still dominates
Slovenian: Terapevtska področja: še vedno prevladuje rak
English: Scientific-advice activity increased noticeably in 2006: 14 requests for scientific advice were received (2 more than the forecast and 4 more than were received in 2005).
Slovenian: Dejavnost znanstvenega svetovanja se je leta 2006 bistveno povečala: prejetih je bilo 14 zahtevkov za znanstveno svetovanje (dve več v primerjavi s predvidenim številom in štirje prejeti zahtevki več kot leta 2005).
English: Further requests for enhancements have been received.
Slovenian: Prejeti so bili dodatni zahtevki za izboljšanja;
English: However, these medicinal products are important treatments for arthritis and other painful conditions, and the overall benefit-risk balance for non-selective NSAIDs remains favourable when used in accordance with the product information.
Slovenian: Ta zdravila so pomembna za zdravljenje artritisa ter ostalih bolečih zdravstvenih stanj, splošno ravnovesje med koristmi in tveganji za neselektivna nesteroidna protivnetna zdravila pa ostaja ugodno, če se uporabljajo v skladu z informacijami o izdelku;
English: Continuing its preparedness efforts for pandemic influenza, the Agency has achieved several milestones in 2006 related to both human and animal health.
Slovenian: Agencija je nadaljevala prizadevanja glede pripravljenosti na pandemijo influence in v letu 2006 dosegla več mejnikov, povezanih z zdravjem ljudi in živali.
English: Revising the mandate of the Agency's Pharmacovigilance Working Party for medicines for veterinary use, making it the core scientific group for monitoring pharmacovigilance matters relating to veterinary medicinal products authorised in the EU.
Slovenian: revizijo pooblastil delovne skupine Agencije za farmakovigilanco za zdravila za uporabo v veterinarski medicini , na podlagi česar je postala temeljna znanstvena skupina za spremljanje farmakovigilančnih zadev, povezanih z veterinarskimi zdravili, za katera so bila izdana dovoljenja v EU;
English: Centrally authorised recombinant hepatitis B vaccines (HBVAXPRO and Procomvax), in relation to the efficacy of the vaccines.
Slovenian: rekombinantnih cepiv proti hepatitisu B, za katera je bilo izdano dovoljenje po centraliziranem postopku (HBVAXPRO in Procomvax), v zvezi z učinkovitostjo cepiv.
English: Alleviation of contra-indications and concomitant strengthening of warnings for beta-interferoncontaining medicinal products used in the treatment of multiple sclerosis.
Slovenian: zmanjšanje kontraindikacij in hkratna okrepitev opozoril za zdravila, ki vsebujejo interferon beta in se uporabljajo pri zdravljenju multiple skleroze.
English: The year saw two firsts: the first certificates issued within the context of cooperation with the World Health Organization, and the first certificates provided free of charge to small and medium-sized enterprises.
Slovenian: Leta 2006 so se prvič zgodili dve stvari: izdana so bila prva potrdila v okviru sodelovanja s Svetovno zdravstveno organizacijo, malim in srednje velikim podjetjem pa so bila zagotovljena prva brezplačna potrdila.
English: Nine of the variations concerning pharmaceuticals related to changes in quality and 5 related to clinical changes.
Slovenian: Devet sprememb se je nanašalo na farmacevtske izdelke, povezane s spremembami kakovosti, pet pa na klinične spremembe.
English: As part of its commitment to providing useful and comprehensible information about the medicines the Agency evaluates, all EPARs for newly authorised medicines are now accompanied by a so-called ‘summary for the public'.
Slovenian: Ker se je Agencija zavezala, da bo zagotavljala koristne in razumljive informacije o zdravilih, ki jih vrednoti, so vsa evropska javna poročila o oceni zdravila zdaj opremljena s tako imenovanim „povzetkom za javnost“.
English: As a complementary action, the Agency's Committee for Medicinal Products for Human Use established a think-tank on innovation, which is expected to report in 2007 on its meetings with pharmaceutical companies and academic groups.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je kot dopolnilni ukrep ustanovil strokovni forum o inovacijah, za katerega se predvideva, da bo v letu 2007 poročal o svojih sestankih s farmacevtskimi družbami in akademskimi skupinami.
English: Totals:
Slovenian: Skupaj:
English: EU Telematics Controlled Terms (a central hub providing agreed and authoritative look-up information for medicinal products in as many EU/EEA languages as possible).
Slovenian: EU Telematics Controlled Terms - nadzorovani telematski izrazi EU (osrednji omrežni razdelilnik, ki zagotavlja vpogled v dogovorjene in veljavne informacije za zdravila v čim večjem možnem številu jezikov EU/EGP).
English: The Agency systematically provided comprehensive information in the form of press releases and question-and-answer documents to explain scientific opinions in a number of areas, including the safety of medicines, new types of applications, new technological advances and the approval procedure for pandemic flu vaccines, as well as general question-and-answer documents to help with communication on subjects such as compassionate use or generic and biosimilar medicines.
Slovenian: Agencija je sistematično zagotavljala izčrpne informacije v obliki sporočil za javnost in dokumentov z vprašanji in odgovori za pojasnitev znanstvenih mnenj na številnih področjih, kot so varnost zdravil, nove vrste vlog, novi tehnološki napredek in postopek odobritve za cepiva za pandemijo influence, ter splošne dokumente z vprašanji in odgovori za pomoč pri komuniciranju o temah, kot so sočutna uporaba generičnih in biološko podobnih zdravil.
English: Other initiatives included the Agency's contribution to establishing recommendations on the ethics of clinical trials in children and to a workshop on medicines for neonates, which allowed the Agency to establish contacts with representatives of patients' organisations and learned societies.
Slovenian: Druge pobude so vključevale prispevek Agencije k oblikovanju priporočil o etiki kliničnih preizkušanj pri otrocih in k delavnicam o zdravilih za novorojenčke, kar je Agenciji omogočilo navezavo stikov s predstavniki organizacij bolnikov in znanstvenimi združenji.
English: The number of post-authorisation opinions adopted was also significantly higher (20%) than in the previous year.
Slovenian: Tudi število sprejetih mnenj po izdaji dovoljenja za promet z zdravilom je bilo bistveno višje (20 %) kot prejšnje leto.
English: Information and communication on veterinary topics
Slovenian: Zagotavljanje informacij in obveščanje o veterinarskih temah
English: Average number of days for centralised procedures (positive opinions), 2004-2006
Slovenian: Povprečno število dni za centralizirane postopke (pozitivna mnenja) v letih 2004-2006
English: 2.7 Herbal medicines Community herbal monographs
Slovenian: 2.7 Zdravila rastlinskega izvora Monografije rastlin Skupnosti
English: For centrally authorised veterinary products, a total of 738 expedited spontaneous reports of suspected adverse reactions were reported within the 15-day legal timeframe in 2006.
Slovenian: Za veterinarske izdelke, za katere je bilo izdano dovoljenje po centraliziranem postopku, se je v 15dnevnem zakonskem roku leta 2006 prijavilo skupaj 738 pospešenih spontanih poročil o sumih na neželene učinke.
English: The number of initial parallel-distribution notifications received in 2006 was 1,408 (113% more than in 2005).
Slovenian: Število začetnih obvestil o vzporedni distribuciji, prejetih leta 2006, je znašalo 1.408 (113 % več kot leta 2005).
English: Following its review of these reports, the CVMP recommended in 7 cases that variations be submitted for the products concerned, mainly concerning the addition of new adverse-reaction information to the product literature.
Slovenian: CVMP je po preučitvi teh poročil v sedmih primerih priporočil, da je treba predložiti spremembe za zadevne proizvode, predvsem v zvezi z vključitvijo novih informacij o neželenih učinkih v literaturo o izdelku.
English: Requests for enhancements have been received.
Slovenian: Prejeti so bili zahtevki za izboljšanja;
English: The system for the centralised procedure is nearly complete, with adjustments for postauthorisation procedures being planned for early 2007.
Slovenian: Sistem za izdelke, za katere je bilo izdano dovoljenje po centraliziranem postopku, je skoraj dokončan, za začetek leta 2007 pa se načrtujejo prilagoditve postopkov po izdaji dovoljenja za promet.
English: New contra-indication for the use of PDE-5 inhibitors in patients suffering from vision loss in one eye because of non-arteritic anterior ischemic optic neuropathy.
Slovenian: nova kontraindikacija za uporabo zaviralcev PDE-5 pri bolnikih z izgubo vida na enem očesu zaradi nearteritisne sprednje ishemične nevropatije vidnega živca;
English: The CVMP continued to extrapolate maximum residue limits (MRLs) to further species, at the request of companies concerned.
Slovenian: CVMP je na zahtevo zadevnih družb nadaljeval ekstrapolacijo najvišjih mejnih vrednoti ostankov na dodatne vrste.
English: The CVMP further reviewed the safety of Cox-2 inhibitors and non-steroidal anti-inflammatory drugs (NSAIDs) for use in veterinary medicine as a result of the conclusion of the review of concerns related to human use of these substances.
Slovenian: CVMP je nadalje preučil varnost zaviralcev COX-2 in nesteroidnih protivnetnih zdravil (NSAID) za uporabo v veterinarski medicini zaradi rezultata zaključka preučitve pomislekov, povezanih z uporabo teh snovi v humani medicini.
English: 3.3 Maximum residue limits Fewer maximum-residue-limit applications submitted than expected
Slovenian: 3.3 Najvišje mejne vrednosti ostankov Manj oddanih vlog za najvišje mejne vrednosti ostankov od pričakovanih
English: This high number of notifications was attributable to: new parallel distributors starting this activity; parallel distributors complying with the mandatory notification procedure; recently authorised medicinal products entering the parallel-distribution chain; and enlargement by existing parallel distributors of their range of products.
Slovenian: Visoko število obvestil je bilo posledica: novih vzporednih distributerjev, ki so se začeli ukvarjati s to dejavnostjo, vzporednih distributerjev, ki ravnajo v skladu z obveznim postopkom obveščanja, zdravil, ki stopajo v verigo vzporedne distribucije in za katera je bilo nedavno izdano dovoljenje za promet, in razširitve palete izdelkov obstoječih vzporednih distributerjev.
English: In December 2006, the EMEA Management Board further extended the pilot scheme for free scientific advice for veterinary medicines for minor uses and minor species.
Slovenian: Upravni odbor EMEA je decembra 2006 dodatno razširil pilotni program za brezplačno znanstveno svetovanje za veterinarska zdravila za manjšo uporabo in manj pomembne vrste.
English: A particularly high number of extensions of indication - 41 (46% more than in 2005) - were introduced in 2006, providing additional treatment options for patients.
Slovenian: Leta 2006 je bilo uvedenih posebej veliko razširitev terapevtskih indikacij - 41 (46 % več kot leta 2005), kar zagotavlja dodatne možnosti zdravljenja za bolnike.
English: The Agency received 79 applications for initial marketing authorisation in 2006, including one concerning a medicinal product intended exclusively for use outside the EU.
Slovenian: Agencija je leta 2006 prejela 79 vlog za izdajo začetnih dovoljenj za promet z zdravilom, vključno z vlogo za zdravilo, namenjeno izključno za uporabo zunaj EU.
English: Positive opinion for first pandemic-influenza ‘mock-up' vaccine
Slovenian: Pozitivno mnenje za prvo „modelno“ cepivo za pandemijo influence
English: Work is required in order to complete the data warehouse and business intelligence functionality, sophisticated signal detection, signal tracking, and implementation of the access policies with regard to all stakeholders.
Slovenian: Potrebno je delo za dokončanje funkcionalnosti podatkovnega skladišča in poslovne inteligence, visoko razvitega odkrivanja signalov, sledenja signalom in izvajanja politik dostopa v zvezi z vsemi zainteresiranimi stranmi;
English: More than 95% of marketing-authorisation holders of centrally authorised products are now in production with the system.
Slovenian: V sistemu zdaj sodeluje več kot 95 % imetnikov dovoljenj za promet z zdravilom, za katero je bilo izdano dovoljenje po centraliziranem postopku.
English: * The figures for 2004 and 2005 have been revised to taken into account the reports submitted for non-centrally authorised products.
Slovenian: * Podatki za leti 2004 in 2005 so bili popravljeni in vključujejo poročila, predložena za izdelke, za katere so bila izdana dovoljenja po decentraliziranem postopku.
English: The CHMP concluded that it cannot be excluded that non-selective NSAIDs may be associated with a small increase in the absolute risk for thrombotic events, especially when used at high doses for long-term treatment.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da ni mogoče izključiti, da so neselektivna nesteroidna protivnetna zdravila lahko povezana z majhnim povečanjem absolutnega tveganja za nastanek trombotičnih stanj, še zlasti če se uporabljajo v velikih dozah za dolgoročno zdravljenje.
English: EudraGMP (EU database of manufacturing authorisations and of certificates of good manufacturing practice).
Slovenian: EudraGMP (zbirka podatkov EU o dovoljenjih za izdelavo in potrdilih o dobri proizvodni praksi).
English: 2.5 Safety of medicines for human use Major safety reviews
Slovenian: 2.5 Varnost zdravil za uporabo v humani medicini Glavne presoje varnosti
English: Highlights of the Management Board's work in 2006 included
Slovenian: Najpomembnejši vidiki dela upravnega odbora v letu 2006 so vključevali:
English: Continuing its activities in the area of pandemic-influenza preparedness, the EMEA: developed a pandemic-influenza crisis-management plan; held a meeting of the Joint EMEA-Industry Task-Force; strengthened contacts with the European Commission Directorate-General for Health and Consumer Protection and with the European Centre for Disease Prevention and Control; had regular communications with the US Food and Drug Administration (FDA) to discuss issues of common interest.
Slovenian: EMEA je z nadaljevanjem dela na področju pripravljenosti na pandemijo influence: razvila načrt kriznega upravljanja pandemije influence, organizirala srečanje skupne projektne skupine EMEA in farmacevtske industrije, okrepila stike z Generalnim direktoratom za zdravje in varstvo potrošnikov Evropske komisije in z Evropskim centrom za preprečevanje in obvladovanje bolezni, redno komunicirala z ameriško Agencijo za hrano in zdravila (Food and Drug Administration - FDA) in z njo razpravljala o vprašanjih skupnega interesa.
English: Among the positive opinions adopted, 11 concerned new orphan products and 2 concerned similar biological (biosimilar) products containing human DNA-recombinant growth hormone.
Slovenian: Izmed sprejetih pozitivnih mnenj se jih je 11 nanašalo na nova zdravila sirote, dve pa na biološko podobne izdelke, ki vsebujejo človeški rekombinantni DNA rasni hormon.
English: EudraVigilance Veterinary
Slovenian: EudraVigilance za veterinarstvo
English: Procedure type
Slovenian: Vrsta postopka
English: Article 5(3)
Slovenian: Člen 5(3)
English: In the context of its efforts to improve availability of medicines for minor uses and minor species, the EMEA's proposal for a list of essential substances for the treatment of certain indications in equidae with no MRL but with a withdrawal period of at least six months was approved by the Commission.
Slovenian: Glede na vsa prizadevanja za izboljšanje razpoložljivosti zdravil za manjše uporabe in manj pomembne vrste je Komisija odobrila predlog EMEA za seznam osnovnih sestavin za zdravljenje določenih terapevtskih indikacij pri kopitarjih brez najvišje mejne vrednosti ostankov, vendar z najmanj 6-mesečno karenco.
English: A new development in 2006 was the receipt of the first applications for generics of centrally authorised products whose 10-year data-exclusivity period has ended: three such applications were received.
Slovenian: Novost v letu 2006 je bil prejem prvih vlog za generična zdravila izdelkov, za katere so bila izdana dovoljenja po centraliziranem postopku in ki se jim je izteklo 10-letno obdobje ekskluzivnosti podatkov: prejete so bile tri take vloge.
English: Cancer still the main therapeutic area concerned
Slovenian: Rak še vedno najpomembnejše terapevtsko področje
English: Scientific advice increasingly sought for gene and cell-therapy products
Slovenian: Naraščajoče število zahtevkov za znanstveno svetovanje za proizvode za gensko in celično zdravljenje