natgillin/translations-raw huggingface dataset:
In 2006, the EMEA received 64 quality-defect reports concerning human medicinal products and 3 quality-defect reports concerning veterinary medicinal products.
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.
Therapeutic areas concerned: cancer still dominates
Terapevtska področja: še vedno prevladuje rak
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).
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).
Further requests for enhancements have been received.
Prejeti so bili dodatni zahtevki za izboljšanja;
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.
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;
Continuing its preparedness efforts for pandemic influenza, the Agency has achieved several milestones in 2006 related to both human and animal health.
Agencija je nadaljevala prizadevanja glede pripravljenosti na pandemijo influence in v letu 2006 dosegla več mejnikov, povezanih z zdravjem ljudi in živali.
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.
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;
Centrally authorised recombinant hepatitis B vaccines (HBVAXPRO and Procomvax), in relation to the efficacy of the vaccines.
rekombinantnih cepiv proti hepatitisu B, za katera je bilo izdano dovoljenje po centraliziranem postopku (HBVAXPRO in Procomvax), v zvezi z učinkovitostjo cepiv.
Alleviation of contra-indications and concomitant strengthening of warnings for beta-interferoncontaining medicinal products used in the treatment of multiple sclerosis.
zmanjšanje kontraindikacij in hkratna okrepitev opozoril za zdravila, ki vsebujejo interferon beta in se uporabljajo pri zdravljenju multiple skleroze.
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.
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.
Nine of the variations concerning pharmaceuticals related to changes in quality and 5 related to clinical changes.
Devet sprememb se je nanašalo na farmacevtske izdelke, povezane s spremembami kakovosti, pet pa na klinične spremembe.
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'.
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“.
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.
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.
Totals:
Skupaj:
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).
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).
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.
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.
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.
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.
The number of post-authorisation opinions adopted was also significantly higher (20%) than in the previous year.
Tudi število sprejetih mnenj po izdaji dovoljenja za promet z zdravilom je bilo bistveno višje (20 %) kot prejšnje leto.
Information and communication on veterinary topics
Zagotavljanje informacij in obveščanje o veterinarskih temah
Average number of days for centralised procedures (positive opinions), 2004-2006
Povprečno število dni za centralizirane postopke (pozitivna mnenja) v letih 2004-2006
2.7 Herbal medicines Community herbal monographs
2.7 Zdravila rastlinskega izvora Monografije rastlin Skupnosti
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.
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.
The number of initial parallel-distribution notifications received in 2006 was 1,408 (113% more than in 2005).
Število začetnih obvestil o vzporedni distribuciji, prejetih leta 2006, je znašalo 1.408 (113 % več kot leta 2005).
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.
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.
Requests for enhancements have been received.
Prejeti so bili zahtevki za izboljšanja;
The system for the centralised procedure is nearly complete, with adjustments for postauthorisation procedures being planned for early 2007.
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.
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.
nova kontraindikacija za uporabo zaviralcev PDE-5 pri bolnikih z izgubo vida na enem očesu zaradi nearteritisne sprednje ishemične nevropatije vidnega živca;
The CVMP continued to extrapolate maximum residue limits (MRLs) to further species, at the request of companies concerned.
CVMP je na zahtevo zadevnih družb nadaljeval ekstrapolacijo najvišjih mejnih vrednoti ostankov na dodatne vrste.
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.
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.
3.3 Maximum residue limits Fewer maximum-residue-limit applications submitted than expected
3.3 Najvišje mejne vrednosti ostankov Manj oddanih vlog za najvišje mejne vrednosti ostankov od pričakovanih
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.
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.
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.
Upravni odbor EMEA je decembra 2006 dodatno razširil pilotni program za brezplačno znanstveno svetovanje za veterinarska zdravila za manjšo uporabo in manj pomembne vrste.
A particularly high number of extensions of indication - 41 (46% more than in 2005) - were introduced in 2006, providing additional treatment options for patients.
Leta 2006 je bilo uvedenih posebej veliko razširitev terapevtskih indikacij - 41 (46 % več kot leta 2005), kar zagotavlja dodatne možnosti zdravljenja za bolnike.
The Agency received 79 applications for initial marketing authorisation in 2006, including one concerning a medicinal product intended exclusively for use outside the EU.
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.
Positive opinion for first pandemic-influenza ‘mock-up' vaccine
Pozitivno mnenje za prvo „modelno“ cepivo za pandemijo influence
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.
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;
More than 95% of marketing-authorisation holders of centrally authorised products are now in production with the system.
V sistemu zdaj sodeluje več kot 95 % imetnikov dovoljenj za promet z zdravilom, za katero je bilo izdano dovoljenje po centraliziranem postopku.
* The figures for 2004 and 2005 have been revised to taken into account the reports submitted for non-centrally authorised products.
* Podatki za leti 2004 in 2005 so bili popravljeni in vključujejo poročila, predložena za izdelke, za katere so bila izdana dovoljenja po decentraliziranem postopku.
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.
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.
EudraGMP (EU database of manufacturing authorisations and of certificates of good manufacturing practice).
EudraGMP (zbirka podatkov EU o dovoljenjih za izdelavo in potrdilih o dobri proizvodni praksi).
2.5 Safety of medicines for human use Major safety reviews
2.5 Varnost zdravil za uporabo v humani medicini Glavne presoje varnosti
Highlights of the Management Board's work in 2006 included
Najpomembnejši vidiki dela upravnega odbora v letu 2006 so vključevali:
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.
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.
Among the positive opinions adopted, 11 concerned new orphan products and 2 concerned similar biological (biosimilar) products containing human DNA-recombinant growth hormone.
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.
EudraVigilance Veterinary
EudraVigilance za veterinarstvo
Procedure type
Vrsta postopka
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.
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.
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.
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.
Cancer still the main therapeutic area concerned
Rak še vedno najpomembnejše terapevtsko področje
Scientific advice increasingly sought for gene and cell-therapy products
Naraščajoče število zahtevkov za znanstveno svetovanje za proizvode za gensko in celično zdravljenje
For those new applications for which the Commission delivered a decision in 2006, the average CVMP assessment time was 183 days - noticeably shorter than the average of 193 days in 2005, partly due to the accelerated assessment of avian-influenza-vaccine applications.
Povprečen čas, ki ga je CVMP potreboval za ocenjevanje novih vlog, za katere je Komisija sprejela mnenje leta 2006, je znašal 183 dni, kar je bistveno manj kot povprečno število 193 dni leta 2005, delno zaradi pospešenega ocenjevanja vlog za cepivo proti aviarni influenci.
The EMEA adopted the first positive opinion for a pandemic-influenza ‘mock-up' vaccine in December 2006.
EMEA je decembra 2006 sprejela prvo pozitivno mnenje za „modelno“ cepivo za pandemijo influence.
Pharmacovigilance activities
Dejavnosti farmakovigilance
Neurology/Central nervous system
Nevrologija/Centralni živčni sistem
Positive opinions per therapeutic area (by ATC code), 2006
Pozitivna mnenja po terapevtskih področjih (glede na oznako ATC) v letu
The same review was conducted for non-centrally authorised pimecrolimus-containing medicinal products (Elidel) under Article 31 of Directive 2001/83/EC, with the same outcome.
Ista presoja je bila opravljena za zdravila, ki vsebujejo pimekrolimus in za katera je bilo izdano dovoljenje po decentraliziranem postopku (Elidel) v skladu s členom 31 Direktive 2001/83/ES, pri čemer je bil rezultat isti;
EudraPharm (database of medicinal products authorised in the European Union to support regulatory activities and to make information on medicinal products available to the public).
EudraPharm (zbirka podatkov o zdravilih, za katera je bilo izdano dovoljenje v Evropski uniji za podporo regulativnih dejavnosti in zagotovitev razpoložljivosti informaciji o zdravilih javnosti).
3.6 Arbitration and Community referrals
3.6 Arbitraža in napotitve Skupnosti
The EMEA has made considerable efforts to increase its outreach to patients and healthcare professionals by providing them more and better information about medicines, most notably with the launch of the EudraPharm database, and by encouraging their participation the Agency's work.
EMEA si je zelo prizadevala, da bi se bolj kot do sedaj približala bolnikom in zdravstvenim delavcem ter jim zagotovila več in boljše informacije o zdravilih, zlasti z vzpostavitvijo zbirke podatkov EudraPharm ter spodbujanjem bolnikov in zdravstvenih delavcev, naj sodelujejo pri delu Agencije.
FOREWORD BY THE CHAIRMAN OF THE MANAGEMENT BOARD
PREDGOVOR PREDSEDNIKA UPRAVNEGA ODBORA
Building and equipmentrelated expenditure (including EU telematics)
Izdatki za stavbe in opremo (vključno s telematiko EU) 34 454 000 EUR
A total of 10 referrals were made to the CVMP in 2006 in the framework of the mutual-recognition procedure.
Odboru za zdravila za uporabo v veterinarski medicini (CVMP) je bilo leta 2006 predloženih skupaj deset napotitev v okviru postopka medsebojnega priznavanja.
Recommendations for a core pharmacovigilance plan for pandemic-influenza vaccines were developed and approved in 2006.
Leta 2006 so bila razvita in odobrena priporočila za temeljni načrt farmakovigilance za cepiva proti pandemiji influence.
These related to an antimicrobial for turkeys and gamebirds (pheasants), a live vaccine for wild rabbits, and development of a vaccine for sheep, goats and cattle.
Ti zahtevki so se nanašali na protimikrobno snov za purane in divje ptice (fazane), živo cepivo za divje zajce in razvoj cepiva za ovce, koze in govedo.
In particular, the total number of type-II variations (including extensions of indication) finalised during 2006 was 35% greater.
Zlasti skupno število dokončno obdelanih vlog za spremembo tipa II (vključno z razširitvijo terapevtskih indikacij) v letu 2006 je bilo za 35 % višje.
EU TELEMATICS STRATEGY
TELEMATSKA STRATEGIJA EU
Eight initial marketing-authorisation applications were received, 5 of which were for pharmaceuticals and 3 for immunologicals.
Prejetih je bilo osem začetnih vlog za izdajo dovoljenja za promet z zdravilom, izmed katerih jih je bilo pet za farmacevtske izdelke in tri za imunološka zdravila.
Three scientific-advice requests were deemed eligible in 2006 for free advice under the provisions of the scheme for minor uses and minor species.
Trije zahtevki za znanstveno svetovanje so leta 2006 izpolnjevali pogoje za brezplačno svetovanje v skladu z določbami programa za manjše uporabe in manj pomembne vrste.
Several extensions of indication were also granted for the diagnosis or treatment of central-nervous-system disorders, diabetes and a range of diseases.
Več razširitev terapevtskih indikacij je bilo odobrenih za diagnozo ali zdravljenje motenj centralnega živčnega sistema, sladkorne bolezni in vrste drugih bolezni.
Cancer and nervous system still the predominant therapeutic areas concerned
Rak in živčni sistem še vedno prevladujoči terapevtski področji
Referral procedures concluded in 2006
Postopki napotitve, zaključeni leta 2006
Public-health benefits of medicines recommended for approval in 2006
Koristi zdravil, priporočenih za odobritev v letu 2006, za javno zdravje
Another new group - the EMEA/CHMP Working Group with Healthcare Professionals' Organisations' - was created in December to make recommendations and proposals for developing a framework of interaction with organisations representing healthcare professionals.
Decembra je bila ustanovljena še ena nova skupina, delovna skupina EMEA/CHMP za sodelovanje z organizacijami zdravstvenih delavcev, ki naj bi pripravljala priporočila in predloge za razvoj okvira sodelovanja z organizacijami, ki predstavljajo zdravstvene delavce.
There was 1 negative opinion (which was confirmed following a re-examination) for an antimicrobial for treatment of specific skin and softtissue infections and specific acute infections of the upper respiratory tract and the urinary tract in cats and dogs.
Sprejeto je bilo tudi eno negativno mnenje (ki je bilo potrjeno po ponovni preučitvi) za protimikrobno snov za zdravljenje posebnih kožnih okužb in okužb mehkega tkiva ter posebnih akutnih okužb zgornjega respiratornega trakta in sečnega trakta pri mačkah in psih.
Preparing guidance on pharmacovigilance for vaccines.
Priprava smernic o farmakovigilanci za cepiva.
The CVMP adopted positive opinions on the authorisation of 13 new veterinary medicines for treatment of a number of conditions in chickens, cats and dogs.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je sprejel pozitivna mnenja glede izdaje dovoljenj za 13 novih veterinarskih zdravil za zdravljenje več bolezni pri piščancih, mačkah in psih;
Preparing guidance on paediatric pharmacovigilance.
Priprava smernic o pediatrični farmakovigilanci.
COMP opinions by therapeutic area, 2006
Mnenja COMP po terapevtskih področjih v letu 2006
The CHMP adopted positive opinions in 3 conditional-approval procedures (concerning products for treatment of cancer, epilepsy and HIV infection) and approved a further 3 products under exceptional circumstances (concerning 1 product for cancer, 1 for an enzyme-deficiency disease, and 1 pandemicinfluenza mock-up vaccine).
Odbor za zdravila za uporabo v humani medicini (CHMP) je sprejel pozitivna mnenja v treh postopkih pogojne odobritve (za proizvode za zdravljenje raka, epilepsije in okužbe s HIV) in odobril nadaljnje tri proizvode v izjemnih okoliščinah (proizvod za rak, proizvod za bolezen pomanjkanja encimov in modelno cepivo proti pandemiji influence).
2.3 Initial evaluation New applications in 2006
2.3 Začetno vrednotenje Nove vloge v letu 2006
The average overall time required for approval of a marketing-authorisation application decreased significantly in 2006, with marked reductions compared to 2005 in the average times for the assessment, post-opinion and decision phases of the procedure.
Povprečni skupni čas, potreben za odobritev vloge za izdajo dovoljenja za promet, se je leta 2006 bistveno skrajšal, pri čemer so se v primerjavi z letom 2005 očitno skrajšali povprečni čas za fazo ocenjevanja, fazo po sprejetju mnenja in fazo odločanja.