FrancophonIA/ELRC3.0 huggingface dataset:
English: [EMA/MB/575364/2010] The Management Board noted the proposal for a written procedure for the adoption of the aforementioned policy which will be launched after the Agency receives the opinion of the European Data Protection Supervisor.
Slovenian: [EMA/MB/575364/2010] Upravni odbor se je seznanil s predlogom pisnega postopka za sprejetje zgoraj navedene politike, ki bo uvedena, ko bo agencija prejela mnenje evropskega nadzornika za varstvo podatkov.
English: The Management Board adopted the procedure for the selection of the Executive Director.
Slovenian: Upravni odbora je sprejel postopek za izbiro izvršnega direktorja.
English: [EMA/MB/603657/2010] The Management Board adopted the transfer of € 4.4 million of ‘provisional appropriation' (€ 5.4 million) that was set aside for possible variations in fee income.
Slovenian: [EMA/MB/603657/2010] Upravni odbor je sprejel prerazporeditev 4,4 milijona EUR „začasnih sredstev“ (5,4 milijona EUR), namenjenih morebitnim spremembam pri prihodkih od pristojbin.
English: • [EMA/496888/2010] Update report on the Agency's implementation of the EU telematics strategy
Slovenian: • [EMA/496888/2010] Dopolnjeno poročilo o izvajanju telematske strategije EU, ki jo izvaja agencija
English: Future accommodation of the Agency
Slovenian: Prihodnji prostori agencije
English: Amendments to Fees payable to the European Medicines Agency and other measures
Slovenian: Spremembe pristojbin, ki se plačujejo agenciji EMA, in drugi ukrepi
English: The current Executive Director will make the appointment.
Slovenian: Imenovanje bo opravil sedanji izvršni direktor.
English: As experience is gathered, the CVMP may need to further clarify the borderline between MUMS and other products.
Slovenian: Po pridobitvi izkušenj bo morebiti potrebno, da odbor za zdravila za uporabo v veterinarski medicini (CVMP) dodatno razjasni mejo med manjšo uporabo in manj pomembnimi živalskimi vrstami ter drugimi proizvodi.
English: • The HMA's endorsement of the draft Memorandum of Understanding on the monitoring of the scientific level and independence of the evaluation carried out by the NCAs for the Agency.
Slovenian: • potrditvijo vodij agencij za zdravila osnutka memoranduma o soglasju o spremljanju znanstvene ravni in neodvisnosti vrednotenja, ki so ga za agencijo pripravili nacionalni pristojni organi;
English: [EMA/MB/575243/2010] The Executive Director had established the Audit Advisory Committee to oversee and advice him on internal controls, financial and risk management, and audits in order to help secure good governance and effective accountability and transparency.
Slovenian: [EMA/MB/575243/2010] Izvršni direktor je ustanovil odbor za presojo in svetovanje za nadzor in svetovanje o notranjem nadzoru, finančnem poslovodenju in obvladovanju tveganj ter presojah kot pomoč pri zagotavljanju dobrega vodenja, učinkovite odgovornosti in preglednosti.
English: Resource consequences, should new responsibilities be granted, need to be examined.
Slovenian: Če bi bile podeljene nove pristojnosti, je treba proučiti, kakšne so posledice za vire.
English: The members noted the update report from the Heads of Medicines Agencies (HMA) on a number of topics, including:
Slovenian: Člani so se seznanili s posodobljenim poročilom vodij agencij za zdravila o različnih temah, vključno s:
English: All three concerned parties - European Commission, ECDC and EMA - have been working together to propose a solution.
Slovenian: Pri tem sodelujejo vse tri zadevne stranke, in sicer Evropska komisija ter agenciji ECDC in EMA.
English: • Presentation on the EMA Policy on the Handling of Conflicts of Interest for Scientific Committee
Slovenian: • Predstavitev politike agencije EMA o obravnavi primerov navzkrižja interesov članov in strokovnjakov znanstvenega odbora
English: [EMA/MB/578243/2010] Taking into account that a new Executive Director will not be selected in time to take office from 1 January 2011, the Board discussed the appointment of an acting Executive Director and recommended the appointment of Andreas Pott, Head of Administration.
Slovenian: Imenovanje vršilca dolžnosti izvršnega direktorja [EMA/MB/578243/2010] Ob upoštevanju, da novi izvršni direktor ne bo izbran pravočasno, da bi delovne naloge začel opravljati s 1. januarjem 2011, je odbor razpravljal o imenovanju vršilca dolžnosti izvršnega direktorja in priporočil Andreasa Potta, vodjo administracije.
English: The report concluded that the new scheme is achieving the objective of incentivising the development and authorisation of new veterinary medicinal products for MUMS.
Slovenian: V poročilu je ugotovljeno, da novi program dosega cilj spodbujanja razvoja in odobritve zdravil za uporabo v veterinarski medicini za manjšo uporabo in manj pomembne živalske vrste.
English: [EMA/MB/528780/2010; EMA/MB/216485/2009; EMA/MB/281870/2010] The Management Board adopted the revised EMA Financial Regulation and implementing rules.
Slovenian: [EMA/MB/528780/2010; EMA/MB/216485/2009; EMA/MB/281870/2010] Upravni odbor je sprejel pregledano finančno uredbo za agencijo EMA in izvedbena pravila.
English: In addition to the annual report, any other reports from the AAC will be presented to the Board.
Slovenian: Odbor za presojo in svetovanje bo upravnemu odboru poleg letnega poročila predložil tudi vsa druga poročila.
English: [EMA/MB/400828/2009] The Board noted that the vacancy notice for the selection of the Executive Director of the EMA will be published on 27 October 2010 with a closing date for applications on 24 November 2010.
Slovenian: [EMA/MB/400828/2009] Upravni odbor se je seznanil, da bo obvestilo o prostem delovnem mestu za izvršnega direktorja agencije EMA objavljeno 27. oktobra 2010 in da bo rok za prijavo 24. november 2010.
English: [EMA/MB/568706/2010] The Management Board adopted the proposed revision to the Agency's internal control standard on sensitive functions.
Slovenian: [EMA/MB/568706/2010] Upravni odbor je sprejel predlagani pregled standarda notranjega nadzora agencije o občutljivih funkcijah.
English: The Board endorsed the AAC approach to its remit in March 2005.
Slovenian: Upravni odbor je marca 2005 potrdil, da je pristop odbora za presojo in svetovanje v njegovi pristojnosti.
English: [EMA/MB/599720/2010] The Management Board endorsed the EudraVigilance status report for Human medicinal products for 2009.
Slovenian: [EMA/MB/599720/2010] Upravni odbor je potrdil Poročilo o stanju sistema EudraVigilance za zdravila za uporabo v humani medicini za leto 2009.
English: [EMA/MB/818152/2009] The Management Board adopted the amendments to the implementing rules on the Agency's fees.
Slovenian: [EMA/MB/818152/2009] Upravni odbor je sprejel spremembe izvedbenih pravil o pristojbinah, ki se plačujejo agenciji.
English: The Agency receives financial statements of each of the organisations during the evaluation of their eligibility to work with the EMA.
Slovenian: Med ocenjevanjem upravičenosti posamezne organizacije za delo z agencijo EMA, ta pošlje agenciji svoj izkaz stanja.
English: A report proposing an operational level solution will be prepared following these discussions and will be presented to the Management Boards of the ECDC and EMA in November and December 2010 respectively.
Slovenian: Na podlagi teh razprav sta bili upravnima odboroma agencij ECDC in EMA novembra in decembra 2010 predloženi poročili s predlogom rešitve na operativni ravni.
English: [EMA/MB/578660/2010] The Board noted the nomination to the CVMP.
Slovenian: [EMA/MB/578660/2010] Odbor se je seznanil z imenovanjem v odbor CVMP.
English: [EMA/MB/404038/2010] The Management Board noted the final minutes, adopted by written procedure on 4 August 2010.
Slovenian: Zapisnik 67. seje, ki je potekala 10. junija 2010 [EMA/MB/404038/2010] Upravni odbor se je seznanil s končnim zapisnikom, ki je bil s pisnim postopkom sprejet 4. avgusta 2010.
English: Audit Advisory Committee contribution paper to the Management Board
Slovenian: Poročilo odbora za presojo in svetovanje upravnemu odboru
English: Consumers' Organisations (PCOs) during 2009 and includes information about the status of implementation of the actions and recommendations that were identified in previous reports.
Slovenian: Dokument opisuje sedanji napredek medsebojnega delovanja med agencijo EMA ter organizacijami bolnikov in potrošnikov v letu 2009 ter vključuje informacije o stanju izvajanja ukrepov in priporočil iz prejšnjih poročil.
English: [EMA/MB/577848/2010; EMA/577855/2010] The Management Board endorsed the annual report on the operation of the Minor Use Minor Species (MUMS) policy and the proposal to continue with the scheme for an additional year.
Slovenian: [EMA/MB/577848/2010; EMA/577855/2010] Upravni odbor je potrdil letno poročilo o delovanju politike glede manjše uporabe in manj pomembnih živalskih vrst (MUMS) ter predlog za podaljšanje programa za dodatno leto.
English: [EMA/MB/511582/2010] The Management Board noted the mid-year report 2010.
Slovenian: [EMA/MB/511582/2010] Upravni odbor se je seznanil z vmesnim poročilom za leto 2010.
English: Apology reveived
Slovenian: Opravičilo
English: [EMA/MB/588579/2010; EMA/MB/589332/2010] The Management Board endorsed the Agency's updated policy on the handling of conflicts of interests of Scientific Committee members and experts, and noted the document providing an overview of the allowable interests for the EMA scientific activities.
Slovenian: [EMA/MB/588579/2010; EMA/MB/589332/2010] Upravni odbor je potrdil dopolnjeno politiko o obravnavi primerov navzkrižja interesov članov ter strokovnjakov znanstvenega odbora in se seznanil z dokumentom o pregledu dovoljenih interesov za znanstvene dejavnosti agencije EMA.
English: Management Board procedure for the selection of the Executive Director
Slovenian: Postopek upravnega odbora za izbiro izvršnega direktorja
English: [EMA/MB/579729/2010] The Management Board noted the report.
Slovenian: [EMA/MB/579729/2010] Upravni odbor se je seznanil s poročilom.
English: • The upcoming meeting with the European Generics Association (EGA) in the margins of the HMA
Slovenian: • prihodnjim sestankom z evropskim združenjem za generična zdravila (EGA) ob robu sestanka vodij agencij za zdravila dne 26. oktobra;
English: The proposal received a favourable opinion from the European Commission.
Slovenian: Evropski komisar je predlog odobril.
English: [EMA/MB/581808/2010; EMA/MB/581875/2010] The Management Board endorsed the EMA Policy on access to documents (related to medicinal products for human and veterinary use) and noted the document outlining outputs of the policy.
Slovenian: [EMA/MB/581808/2010; EMA/MB/581875/2010] Upravni odbor je potrdil politiko agencije EMA o dostopu do dokumentov (v povezavi z zdravili za uporabo v humani in veterinarski medicini) in se seznanil z dokumentom, ki opisuje učinke politike.
English: Held in London on 7 October 2010
Slovenian: V Londonu,7.
English: [EMA/MB/559867/2010] The Management Board endorsed the proposal to establish a joint CVMP/CHMP ad-hoc expert group on the application of the 3Rs in the development of medicinal products.
Slovenian: [EMA/MB/559867/2010] Upravni odbor je potrdil predlog o ustanovitvi skupne strokovne skupine odborov CVMP in CHMP za uporabo zamenjave, zmanjšanja in izboljšane uporabe živali pri razvoju zdravil.
English: Product suspension
Slovenian: Začasni umik zdravila
English: Doctors' organisations to Commissioner John Dallli on the proposed revised EMA Policy on the
Slovenian: • Dopis predstavnika Evropskega parlamenta upravnemu odboru in predstavnika organizacij zdravnikov komisarju Johnu Sallliju o predlagani revidirani politike agencije EMA o obravnavi primerov navzkrižja interesov članov in strokovnjakov znanstvenega odbora
English: • [EMA/MB/539466/2010] MBTC's Telematics Implementation Group: Chair's appointment procedure and role
Slovenian: • [EMA/MB/539466/2010] Skupina za izvajanje odbora za telematiko pri upravnem odboru agencije:
English: AOB
Slovenian: Razno
English: • Presentation on the EMA accommodation strategy
Slovenian: • Predstavitev strategije za iskanje prihodnjih prostorov agencije
English: The company applied for a change (variation) to the marketing authorisation to add a new indication to be recognised by Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom (the ‘concerned Member States').
Slovenian: Podjetje je zaprosilo za spremembo dovoljenja za promet z zdravilom, da bi vanj vključili novo indikacijo, ki bi jo priznali Avstrija, Belgija, Bolgarija, Ciper, Češka, Danska, Estonija, Finska, Francija, Grčija, Madžarska, Islandija, Irska, Italija, Latvija, Litva, Luksemburg, Nizozemska, Norveška, Poljska, Portugalska, Romunija, Slovaška, Slovenija, Španija, Švedska in Združeno kraljestvo („zadevne države članice“).
English: Why was Seresto reviewed?
Slovenian: Zakaj je bilo zdravilo Seresto pregledano?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom25 May 2018
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom25.
English: The company that markets the product is Bayer Vital GmbH.
Slovenian: Podjetje, ki zdravilo trži, je Bayer Vital GmbH.
English: Seresto is an antiparasitic collar containing 10% imidacloprid and 4.5% flumethrin.
Slovenian: Zdravilo Seresto je protiparazitna ovratnica, ki vsebuje 10 % imidakloprida in 4,5 % flumetrina.
English: Seresto is authorised in the European Union (EU) under the decentralised procedure with Germany as the reference Member State.
Slovenian: Zdravilo Seresto je bilo v Evropski Uniji (EU) odobreno po decentraliziranem postopku, pri čemer je bila Nemčija referenčna država članica.
English: Because these Member States were not able to reach an agreement, the German Federal Office of Consumer Protection and Food Safety (BVL) referred the matter to the CVMP for arbitration on 18 August 2017.
Slovenian: Ker zadevne države članice niso mogle doseči soglasja, je nemški zvezni urad za varstvo potrošnikov in varnost hrane (BVL) 18. avgusta 2017 zadevo napotil na odbor CVMP v arbitražo.
English: It is indicated for the treatment and prevention of infestations with fleas, ticks and lice in dogs and cats, and provides indirect protection against the diseases babesiosis and ehrlichiosis, which can be transmitted to dogs by ticks.
Slovenian: Zdravilo Seresto je namenjeno zdravljenju in preprečevanju infestacij z bolhami, klopi in ušmi pri psih in mačkah ter nudi posredno zaščito proti boleznima babeziozi in ehrlichiozi, s katerima lahko pse okužijo klopi.
English: Questions and answers on Seresto and its associated name Foresto EMA/392857/2018
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Seresto in povezanim imenom Foresto EMA/468950/2018
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that the efficacy of Seresto in the reduction of the risk of infection with Leishmania infantum via transmission by sand flies for up to 8 months had been sufficiently demonstrated and therefore the variation to the marketing authorisation can be approved in all concerned Member States.
Slovenian: Na podlagi vrednotenja trenutno razpoložljivih podatkov in znanstvene razprave znotraj Odbora je odbor CVMP odločil, da je učinkovitost zdravila Seresto pri zmanjševanju tveganja okužbe s parazitom Leishmania infantum po prenosu s flebotomi v do osmih mesecih zadostno dokazana, zato je odobril spremembo dovoljenja za promet z zdravilom Seresto v vseh zadevnih državah članicah.
English: The proposed new indication was against the disease leishmaniosis, which is caused by the parasite Leishmania infantum and transmitted to dogs by sand flies.
Slovenian: Predlagana nova indikacija je bila proti bolezni leishmaniozi, ki jo povzroča parazit Leishmania infantum, na pse pa jo prenašajo flebotomi.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the change to the marketing authorisation for Seresto to add a new indication can be granted.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da se lahko odobri sprememba dovoljenja za promet z zdravilom Seresto z vključitvijo nove indikacije.
English: On 15 February 2018, the European Medicines Agency (the Agency) completed an arbitration procedure for Seresto and its associated name Foresto.
Slovenian: Evropska agencija za zdravila (v nadaljnjem besedilu: agencija) je 15. februarja 2018 zaključila arbitražo za zdravilo Seresto in povezano ime Foresto.
English: What is Seresto?
Slovenian: Kaj je zdravilo Seresto?
English: Seresto, sometimes under its associated name Foresto, is authorised in nearly all EU/EEA Member States.
Slovenian: Zdravilo Seresto je odobreno v skoraj vseh državah članicah EU/EGP, včasih pod povezanim imenom Foresto.
English: Questions and answers on Seresto and its associated name Foresto
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Seresto in povezanim imenom Foresto
English: The European Commission issued an EU-wide legally binding decision to implement the CVMP recommendations on Seresto on 25 May 2018.
Slovenian: Evropska komisija je 25. maja 2018 izdala končni pravno zavezujoč sklep za vse države članice EU, da uvedejo priporočila odbora CVMP o zdravilu Seresto.
English: The grounds for the referral were the concerns of the UK that the efficacy of the product in repelling sand flies had not been sufficiently demonstrated.
Slovenian: Razlog za napotitev v arbitražo so bili dvomi Združenega kraljestva o učinkovitosti zdravila, saj njegova sposobnost odbijanja flebotomov ni bila zadostno dokazana.
English: However, the CVMP recommended inclusion of the statement, in the product information of Seresto, that the demonstrated repellent efficacy against sand flies was variable.
Slovenian: Odbor CVMP je vseeno priporočil, da se v informacije o zdravilu Seresto doda navedba, da je bila dokazana učinkovitost zdravila pri odbijanju flebotomov spremenljiva.
English: 10 ml (3.5 mg/ml) 5 (5 x 1) vial (multipack)
Slovenian: 10 ml (3,5 mg/ml) 5 (5 x 1) vial (večje pakiranje)
English: blister (aclar/alu) 56 tablets blister (aclar/alu);card
Slovenian: Stična ovojnina Velikost pakiranja peroralna uporaba plastenka (HDPE) 56 tablet peroralna uporaba pretisni omot (aclar/alu)
English: Pack size bottle (HDPE)
Slovenian: peroralna uporaba pretisni omot (aclar/alu); zgibanka
English: 4 (1x4) vials
Slovenian: 4 (1x4) viale
English: 150 mg/ml Solution for injection
Slovenian: 150 mg/ml raztopina za injiciranje subkutana uporaba
English: It was expected to be available as a powder and solvent to make up a solution for injection (500, 1,000 and 1,500 units).
Slovenian: Na voljo naj bi bilo v obliki praška in vehikla za pripravo raztopine za injiciranje (500, 1000 in 1500 enot).
English: This causes problems with blood clotting, leading to bleeding into the joints, muscles and internal organs.
Slovenian: Posledica so težave s strjevanjem krvi, ki privedejo do krvavitev v sklepe, mišice in notranje organe.
English: The company expressed its intention to re-apply for marketing authorisation once the data were available.
Slovenian: Družba je navedla, da namerava ponovno vložiti vlogo za pridobitev dovoljenja za promet z zdravilom, ko bodo ti podatki na voljo.
English: Effectiveness was measured by the patients' assessment of how well bleeding was controlled, and by the number of bleeding episodes that occurred while receiving the medicine.
Slovenian: Učinkovitost so merili na podlagi ocene bolnikov o tem, kako dobro so bile nadzorovane krvavitve, in števila krvavitev, ki so se pojavile v času uporabe zdravila.
English: The company refined the manufacturing process for IXinity to remove these proteins, but it was not clear if the refined medicine would act in the same way as the original product in the studies, and the CHMP recommended further study in patients.
Slovenian: Družba je izboljšala postopek izdelave zdravila IXinity, da bi odstranila te beljakovine, vendar ni jasno, ali bi izboljšano zdravilo delovalo na enak način, kot je v študijah delovalo originalno zdravilo, zato je CHMP priporočil dodatno študijo pri bolnikih.
English: What is IXinity?
Slovenian: Kaj je zdravilo IXinity?
English: On 13 June 2013, Cangene Europe Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for IXinity, for the treatment and prevention of bleeding in patients with haemophilia B.
Slovenian: Družba Cangene Europe Ltd. je dne 13. junija 2013 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom IXinity, namenjenim zdravljenju in preprečevanju krvavitev pri bolnikih s hemofilijo B.
English: The company presented the results of studies involving 42 patients with moderate or severe haemophilia B who were given IXinity for treatment or prevention of bleeding, including some patients undergoing surgery.
Slovenian: Družba je predložila rezultate študij, v katerih je sodelovalo 42 bolnikov z zmerno ali hudo hemofilijo B, ki so prejemali zdravilo IXinity za zdravljenje ali preprečevanje krvavitev, vključno z nekaj bolniki, pri katerih je bil opravljen operativni poseg.
English: The company informed the CHMP that patients currently included in clinical trials would continue to receive IXinity and would be switched to the refined product once revised rules for the conduct of the trials had been approved.
Slovenian: Družba je CHMP obvestila, da bodo bolniki, ki trenutno sodelujejo v kliničnih preskušanjih, še naprej prejemali zdravilo IXinity, po odobritvi spremenjenih pravil za izvedbo preskušanj pa bodo prešli na izboljšano zdravilo.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that based on the currently available data the balance of the benefit and risks of the refined IXinity product was negative.
Slovenian: Posledično je CHMP v času umika menil, da je na podlagi trenutno razpoložljivih podatkov razmerje med koristmi in tveganji za izboljšano zdravilo IXinity negativno.
English: IXinity is a medicine that contains the active substance trenonacog alfa (recombinant human factor IX).
Slovenian: IXinity je zdravilo, ki vsebuje zdravilno učinkovino trenonakog alfa (rekombinantni humani faktor IX).
English: IXinity was expected to be used to prevent and treat bleeding episodes in patients at least 12 years of age with haemophilia B (an inherited bleeding disorder caused by lack of factor IX).
Slovenian: Zdravilo IXinity naj bi se uporabljalo za preprečevanje in zdravljenje krvavitev pri bolnikih, starih najmanj 12 let, s hemofilijo B (dedno motnjo strjevanja krvi zaradi pomanjkanja faktorja IX).
English: Although the studies had shown evidence of the effectiveness of IXinity, they had also revealed that patients developed an unexpectedly high level of antibodies against proteins from the cells used to make IXinity, which were also present in the medicine.
Slovenian: Čeprav so v študijah pridobili dokaze o učinkovitost zdravila IXinity, so opazili tudi, da so se pri bolnikih tvorile nepričakovano visoke ravni protiteles proti beljakovinam iz celic, uporabljenih za izdelavo zdravila IXinity, ki so bile prisotne v zdravilu.
English: Withdrawal of the marketing authorisation application for IXinity (trenonacog alfa)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom IXinity (trenonakog alfa)
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that IXinity could not have been approved for the prevention and treatment of bleeding episodes in patients with haemophilia B.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil CHMP, je odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila IXinity ni mogoče odobriti za preprečevanje in zdravljenje krvavitev pri bolnikih s hemofilijo B.