FrancophonIA/ELRC3.0 huggingface dataset:
English: The Board reflected on the question of leadership for the identified tasks.
Danish: Bestyrelsen drøftede spørgsmålet om ledelse i forbindelse med de fastlagte opgaver.
English: The Board noted that the Agency plans to complete an overarching transparency policy in 2011.
Danish: Bestyrelsen noterede sig, at agenturet planlægger at fastlægge en overordnet gennemsigtighedspolitik i 2011.
English: The next step in the transparency process will be agreeing on a common approach for deletion of commercially confidential information from application files.
Danish: Næste trin i gennemsigtighedsprocessen bliver at fastlægge en fælles fremgangsmåde for sletning af kommercielt fortrolige oplysninger i ansøgningerne.
English: The arrangements outline the areas in which enhanced cooperation may take place, make provision for mutual consultation and coordination, and address confidentiality issues.
Danish: Aftalerne beskriver de områder, hvor et øget samarbejde kan finde sted, danner grundlag for bestemmelser vedrørende gensidig høring og samarbejde og behandler fortrolighedsspørgsmål.
English: The Board mandated the Executive Director to engage in further discussions with the Commission and with ECDC.
Danish: Bestyrelsen gav den administrerende direktør mandat til at drøfte sagen yderligere med Kommissionen og ECDC.
English: The Board therefore stressed that the European Medicines Agency should take a more prominent role in the vigilance and traceability of SoHO.
Danish: Bestyrelsen understregede derfor, at Det Europæiske Lægemiddelagentur bør indtage en mere fremtrædende rolle i forbindelse med overvågning og sporbarhed af stoffer af menneskelig oprindelse.
English: The meeting reflected on a wider issue: potential risks to supply of medicines in cases where patients become dependent on special delivery systems that lack intercompatibility across products.
Danish: Der blev drøftet et mere omfattende problem på mødet: potentielle risici i forbindelse med levering af lægemidler i de tilfælde, hvor patienter bliver afhængige af særlige leveringssystemer, hvor der mangler gensidig overensstemmelse mellem lægemidler.
English: Nominations to the Agency's scientific committees
Danish: Udnævnelser til agenturets videnskabelige udvalg
English: The legislation vests new or extended responsibilities on the Agency in various areas, including periodic safety update reports, adverse drug reactions, communication, risk management and audits of pharmacovigilance systems.
Danish: Lovgivningen pålægger agenturet nye eller udvidede ansvarsområder på forskellige områder, herunder periodiske opdaterede sikkerhedsindberetninger, lægemiddelbivirkninger, kommunikation, risikostyring og revisioner af lægemiddelovervågningssystemer.
English: The road map will be published in January 2011.
Danish: Køreplanen offentliggøres i januar 2011.
English: • Presentation: From vision to reality: Implementing the road map to 2015.
Danish: • Præsentation: Fra vision til virkelighed: Gennemførelse af køreplanen frem til 2015.
English: The following members agreed to participate in this work: Aginus Kalis, Marcus Müllner, Björn Lemmer, Tamás Paál, Rita Purcell, Guido Rasi, Lisette Tiddens and Gro Wesenberg.
Danish: Følgende medlemmer sagde ja til at deltage i dette arbejde: Aginus Kalis, Marcus Müllner, Björn Lemmer, Tamás Paál, Rita Purcell, Guido Rasi, Lisette Tiddens og Gro Wesenberg.
English: The Commission's proposal will be presented to the Management Board in March 2011.
Danish: Kommissionens forslag vil blive fremlagt for bestyrelsen i marts 2011.
English: Implementation of pharmacovigilance legislation
Danish: Gennemførelse af lovgivning om lægemiddelovervågning
English: Road map
Danish: Køreplan
English: The availability of contingency arrangements and ensuring that companies are prepared to solve such situations are essential.
Danish: Det er vigtigt at sørge for, at der findes nødordninger, og sikre, at virksomheder vil påtage sig at løse sådanne situationer.
English: The Management Board asked the group of topic coordinators to consider opinions that have been put forward, and to make a proposal to streamline the procedure at a future meeting.
Danish: Bestyrelsen bad gruppen af emnekoordinatorer overveje de udtalelser, der er blevet fremsat, og fremlægge et forslag til forbedring af proceduren på et kommende møde.
English: Management Board consultation procedure for nominations to Committees for Medicinal Products for Human and Veterinary Use (CHMP and CVMP)
Danish: Bestyrelsens høringsprocedure for udnævnelser til Udvalget for Lægemidler til Mennesker (CHMP) og Udvalget for Veterinærlægemidler (CVMP)
English: • [EMA/MB/821069/2010] Periodic report on signal detection activities and EudraVigilance - Interim report - 01/01/10 to 30/06/10.
Danish: • [EMA/MB/821069/2010] Periodisk rapport om signalstyringsaktiviteter og EudraVigilance foreløbig rapport - 01/01/10 to 30/06/10.
English: The Executive Director informed the Board that the Agency has received a qualified opinion from the Court of Auditors for the first time.
Danish: Den administrerende direktør informerede bestyrelsen om, at agenturet for første gang har fået en erklæring med forbehold fra Revisionsretten.
English: • Progress on review of the veterinary medicines legislation.
Danish: • Fremskridt med hensyn til revisionen af lovgivning vedrørende lægemidler til dyr.
English: European Commission Paola Testori Coggi Pedro Ortun Silvan
Danish: Europa-Kommissionen Paola Testori Coggi Pedro Ortun Silvan
English: EudraVigilance access policies for medicinal products for human and veterinary use
Danish: Politikker for EudraVigilance-aktindsigt i forbindelse med lægemidler til mennesker og dyr
English: [EMA/MB/691944/2010] The Board noted that the Agency will continue the development of all projects planned during the preliminary draft budget stage, in spite of significant reduction of available appropriations in the draft budget 2011.
Danish: [EMA/MB/691944/2010] Bestyrelsen noterede sig, at agenturet vil fortsætte udviklingen af alle de projekter, der er planlagt i forbindelse med udarbejdelsen af det foreløbige budgetforslag, selvom antallet af disponible bevillinger i budgetforslaget 2011 er reduceret betydeligt.
English: If an issue arises, the replacement of products becomes difficult in such situations.
Danish: Hvis der opstår et problem, bliver det i sådanne situationer vanskeligt at levere erstatningslægemidler.
English: Brigitte Batliner (Liechtenstein) Gro Ramsten Wesenberg (Norway)
Danish: Brigitte Batliner (Liechtenstein) Gro Ramsten Wesenberg (Norge)
English: The Board adopted the Agency's budget, establishment plan and staff policy plan for 2011.
Danish: Bestyrelsen vedtog agenturets budget, stillingsfortegnelse og personalepolitiske plan for 2011.
English: • Presentation: Implementation of the new pharmacovigilance legislation.
Danish: • Præsentation: Gennemførelse af den nye lovgivning vedrørende lægemiddelovervågning.
English: Held in London on 16 December 2010
Danish: møde i London den 16. december 2010
English: Members exchanged information about the handling of the quality defects of certain medicinal products for peritoneal dialysis.
Danish: Medlemmerne udvekslede oplysninger om håndteringen af kvalitetsmangler ved bestemte lægemidler til peritonealdialyse.
English: Taking into account the opinion of topic coordinators, the Board gave a mandate to the Executive Director to look in more detail at options.
Danish: Under hensynstagen til udtalelsen fra emnekoordinatorerne gav bestyrelsen den administrerende direktør beføjelse til at undersøge muligheder mere indgående.
English: The Management Board noted the proposal for the following two sessions for 16 March 2011: health technology assessment and the implementation of the pharmacovigilance legislation.
Danish: Bestyrelsen planlægger at afholde et møde af to dages varighed i marts Bestyrelsen tog forslaget til følgende to møder den 16. marts 2011 til efterretning: medicinsk teknologivurdering og gennemførelsen af lovgivning vedrørende lægemiddelovervågning.
English: The Management Board was given a presentation about the outcome of the feasibility study, and continued its reflection on options for the accommodation of the Agency following the expiry of the current lease.
Danish: Bestyrelsen fik præsenteret resultatet af gennemførlighedsundersøgelsen og fortsatte drøftelsen af agenturets mulige lokaler efter udløbet af den nuværende lejekontrakt.
English: The Management Board heard the presentation on how the Agency is preparing for the implementation of the pharmacovigilance legislation.
Danish: Bestyrelsen fik forelagt en præsentation af, på hvilken måde agenturet forbereder gennemførelsen af lovgivningen vedrørende lægemiddelovervågning.
English: Evaluation of the Agency
Danish: Agenturets evaluering
English: Minutes of the 69th meeting of the Management Board
Danish: Referat af bestyrelsens 69.
English: Budget, establishment plan and staff policy plan 2011
Danish: Budget, stillingsfortegnelse og plan for personalepolitikken 2011
English: [EMA/MB/761407/2010] The Management Board adopted the 'Road map to 2015', which outlines the Agency's vision for the coming years.
Danish: [EMA/MB/761407/2010] Bestyrelsen vedtog "Køreplan frem til 2015", som beskriver agenturets visioner for de kommende år.
English: Members added a new point about potential quality defects of certain medicinal products for peritoneal dialysis.
Danish: Medlemmerne tilføjede et nyt punkt om potentielle kvalitetsmangler ved bestemte lægemidler til peritonealdialyse.
English: • Presentation: Road map to 2015.
Danish: • Præsentation: Køreplan frem til 2015.
English: The policies had been endorsed by the Heads of Medicines Agencies.
Danish: Disse politikker er blevet godkendt af cheferne for de nationale lægemiddelstyrelser.
English: The plan will be presented to the Board for adoption in March 2011.
Danish: Planen fremlægges for bestyrelsen til vedtagelse i marts 2011.
English: • [EMA/MB/694689/2010] Summary of transfers of appropriations in the budget 2010.
Danish: • [EMA/MB/694689/2010] Sammendrag af bevillingsoverførsler på budgettet for 2010.
English: Rannveig Gunnarsdóttir (Iceland)
Danish: Rannveig Gunnarsdóttir (Island)
English: Working arrangements
Danish: Arbejdsaftaler
English: The Board was informed that the European Ombudsman gave a positive evaluation of the Agency's access-to-documents policy.
Danish: Bestyrelsen blev informeret om, at Den Europæiske Ombudsmand godkendte agenturets politik for aktindsigt.
English: • [EMA/MB/739297/2010] Outcome of written procedures during the period from 17 October 2010 to
Danish: • [EMA/MB/739297/2010] Resultat af skriftlige procedurer i perioden fra den 17. oktober 2010 til den 24. november 2010.
English: (The Board noted that a shortlist of candidates will be presented to the Board by the end of March 2011 at the earliest.
Danish: (Bestyrelsen noterede sig, at den tidligst ved udgangen af marts 2011 vil få fremlagt en slutliste over kandidater).
English: • [EMA/674449/2010] Update report on the Agency's implementation of the EU telematics strategy.
Danish: • [EMA/674449/2010] Ajourført rapport om agenturets gennemførelse af EU's telematikstrategi.
English: [EMA/MB/703910/2010] The Management Board noted that it will be requested to adopt the nonautomatic carry-over of appropriations by written procedure.
Danish: [EMA/MB/703910/2010] Bestyrelsen noterede sig, at den vil blive anmodet om at vedtage den ikkeautomatiske overførsel af bevillinger gennem en skriftlig procedure.
English: 7 February 2011 EMA/MB/808316/2010 corr.
Danish: 7. februar 2011 EMA/440508/2011 corr.
English: The Agency had to compensate these positions by increasing the levels of contract agents and national experts for 2011.
Danish: Budgetmyndigheden godkendte ikke de ønskede 48 stillinger Agenturet var nødt til at kompensere for disse stillinger ved at øge antallet af kontraktagenter og nationale eksperter i 2011.
English: Cooperation on substances of human origin (SoHO)
Danish: Samarbejde om stoffer af menneskelig oprindelse
English: Court of Auditors
Danish: Revisionsretten
English: [EMA/MB/751837/2010] The Management Board endorsed the hourly cost for 2011 of €40 (the same rate as in 2009 and 2010).
Danish: [EMA/MB/751837/2010] Bestyrelsen godkendte timeprisen for 2011 på 40 euro (samme sats som i 2009 og 2010).
English: The members noted the written update from the Heads of Medicines Agencies (HMA).
Danish: Medlemmerne tog den skriftlige opdatering fra cheferne for de nationale lægemiddelstyrelser til efterretning.
English: [EMA/MB/739310/2010] Following the comments received during the written consultation procedure, the Management Board endorsed the nomination to the CVMP and concluded the consultation procedure.
Danish: [EMA/MB/739310/2010] På baggrund af de kommentarer, der blev modtaget i forbindelse med den skriftlige høringsprocedure, godkendte bestyrelsen kandidaterne til CVMP og afsluttede høringsproceduren.
English: [EMA/MB/739310/2010] The Management Board discussed ways to streamline the consultation procedure.
Danish: [EMA/MB/739310/2010] Bestyrelsen drøftede måder at forbedre høringsproceduren på.
English: • Presentation: Project 2014 - Feasibility study on the future accommodation of the European Medicines Agency.
Danish: • Præsentation: Projekt 2014 - Gennemførlighedsundersøgelse af Det Europæiske
English: • Pharmacovigilance legislation (the publication is imminent and the new legislation will be applicable mid 2012).
Danish: • Lægemiddelovervågning (offentliggørelsen nærmer sig, og den nye lovgivning vil gælde fra midt i
English: [EMA/MB/784261/2010; EMA/MB/132208/2010; EMA/MB/637740/2010] Following the adoption of the EU budget, this agenda point was presented to the Management Board for adoption.
Danish: [EMA/MB/784261/2010; EMA/MB/132208/2010; EMA/MB/637740/2010] Efter vedtagelsen af EUbudgettet blev dette punkt fremlagt for bestyrelsen til vedtagelse.
English: [EMA/MB/660138/2010] The agenda was adopted with amendments.
Danish: [EMA/MB/660138/2010] Dagsordenen blev vedtaget med ændringer.
English: • Presentation: Developing a vigilance system for substances of human origin (SoHO) at European level - Technical introduction.
Danish: • Præsentation: Udvikling af et overvågningssystem for stoffer af menneskelig oprindelse på EU-plan
English: • [EMA/MB/743560/2010] Update report from the Management Board Telematics Committee.
Danish: • [EMA/MB/743560/2010] Ajourført rapport fra bestyrelsens telematikudvalg.
English: [EMA/MB/754407/2010; EMA/MB/777113/2010] The Management Board adopted the EudraVigilance access policies for medicinal products for human and veterinary use.
Danish: [EMA/MB/754407/2010; EMA/MB/777113/2010] Bestyrelsen vedtog politikkerne vedrørende EudraVigilance-aktindsigt i forbindelse med lægemidler til mennesker og dyr.
English: [EMA/MB/628133/2010] The Management Board adopted the minutes.
Danish: [EMA/MB/628133/2010] Bestyrelsen vedtog referatet.
English: Implementation of budget 2011 with provisional twelfth
Danish: Gennemførelse af budget 2001 med foreløbig 12.
English: [EMA/MB/482208/2010] The Management Board adopted the work programme 2011.
Danish: [EMA/MB/482208/2010] Bestyrelsen vedtog arbejdsprogrammet for 2011.
English: [EMA/MB/783955/2010; EMA/520678/2010] The Management Board endorsed the working arrangements with ECDC.
Danish: [EMA/MB/783955/2010; EMA/520678/2010] Bestyrelsen godkendte arbejdsaftalerne med ECDC.
English: • [EMA/MB/719548/2010] Ash cloud impact report.
Danish: • [EMA/MB/719548/2010] Rapport om konsekvenser af askeskyen.
English: 24 November 2010.
Danish: møde den 7. oktober 2010
English: [EMA/MB/784727/2010; EMA/MB/791259/2010] According to the legislation, the European Commission has to set up a system for vigilance and traceability of SoHO. ECDC had prepared a paper outlining the management of operational EU-level tasks related to substances of human origin.
Danish: [EMA/MB/784727/2010; EMA/MB/791259/2010] Europa-Kommissionen skal i henhold til lovgivningen iværksætte et system for overvågning og sporbarhed af stoffer af menneskelig oprindelse.
English: Apology received
Danish: Afbud
English: Other
Danish: Eventuelt
English: Representative of healthcare professionals' organisations
Danish: Repræsentanter for lægeorganisationer
English: Minutes from the 68th meeting, held on 7 October 2010
Danish: Referat af det 68.
English: These medicines should continue to be used as before.
Danish: Lægemidlerne bør fortsat anvendes som hidtil.
English: The European Commission issued a decision for Orlistat Art. 31 on 24 April 2012.
Danish: Europa-Kommissionen traf sin artikel 31-afgørelse vedrørende orlistat den 24. april 2012.
English: What is orlistat?
Danish: Hvad er orlistat?
English: Xenical and Alli are together estimated to have been used by over 53 million people worldwide, with over 20 million in the EU.
Danish: Xenical og Alli skønnes tilsammen at være blevet anvendt af over 53 millioner mennesker i hele verden, heraf over 20 millioner i EU.
English: A number of generic orlistat-containing medicines have also been authorised via national procedures in Belgium, Bulgaria, Denmark, Estonia, Latvia, Lithuania, Norway, Portugal, Slovakia, the Netherlands, and the United Kingdom.
Danish: Desuden er der godkendt en række generiske lægemidler indeholdende orlistat via nationale procedurer i Belgien, Bulgarien, Danmark, Estland, Letland, Litauen, Norge, Portugal, Slovakiet, Nederlandene og Det Forenede Kongerige.
English: Why was orlistat reviewed?
Danish: Hvorfor blev orlistat vurderet igen?
English: This risk has been closely monitored by the CHMP and measures to manage the known risks were put in place.
Danish: Denne risiko er blevet tæt overvåget af CHMP, og der er indført foranstaltninger til håndtering af de kendte risici.
English: The product information for Alli, which currently lists ‘hepatitis', will be updated accordingly.
Danish: Produktinformationen for Alli, der på nuværende tidspunkt angiver “hepatitis”, skal ajourføres i overensstemmelse hermed.
English: Patients should stop taking orlistat and inform their doctor if they experience any of these symptoms.
Danish: Patienterne bør ophøre med at bruge orlistat og fortælle det til lægen, hvis de får nogen af disse symptomer.
English: The amended information to doctors and patients are detailed here.
Danish: Den ændrede produktinformation til læger og patienter findes her.
English: Orlistat is an anti-obesity medicine, which does not affect appetite.
Danish: Orlistat er et lægemiddel, der anvendes mod fedme og ikke påvirker appetitten.
English: Since authorisation, there have been some reports of severe liver problems in users of these medicines.
Danish: Siden godkendelsen er der indberettet nogle tilfælde af alvorlige leverproblemer hos brugere af disse lægemidler.
English: The body does not absorb this fat and this helps the patient reduce their weight.
Danish: Kroppen absorberer ikke dette fedtstof, og derved bliver det lettere for patienten at tabe sig.
English: Two orlistat-containing medicines hold an EU-wide marketing authorisation.
Danish: To lægemidler indeholdende orlistat er godkendt til markedsføring i hele EU.
English: Consequently, the European Commission asked the CHMP to issue an opinion on orlistat and on whether the marketing authorisation for orlistat-containing medicines should be maintained, varied, suspended or withdrawn across the EU.
Danish: Europa-Kommissionen anmodede derfor CHMP om at udarbejde en udtalelse om orlistat og om, hvorvidt markedsføringstilladelserne for lægemidler indeholdende orlistat bør opretholdes, ændres, suspenderes eller inddrages i hele EU.
English: Orlistat blocks the action of gastrointestinal lipases (enzymes that digest fat).
Danish: Orlistat blokerer virkningen af gastrointestinale lipaser (enzymer, der nedbryder fedt).
English: Since 2001 it has been recognised that some patients taking orlistat could experience very rare liverrelated side effects.
Danish: Siden 2001 har man vidst, at nogle patienter, der får orlistat, kan få meget sjældne leverrelaterede bivirkninger.
English: The current European public assessment report for Alli can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den nuværende europæiske offentlige vurderingsrapport for Alli findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Xenical was authorised in 1998 and is available as capsules (120 mg) which can only be obtained with a prescription.
Danish: Xenical blev godkendt i 1998 og leveres som kapsler (120 mg), der kun udleveres mod recept.
English: The current European public assessment report for Xenical can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den nuværende europæiske offentlige vurderingsrapport for Xenical findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: • Patients should note that symptoms of hepatitis can include yellowing skin and eyes, itching, dark coloured urine, stomach pain and liver tenderness (indicated by pain under the front of the rib cage), sometimes with a loss of appetite.
Danish: • Patienterne bør være opmærksomme på, at symptomerne på hepatitis kan bestå i gulfarvning af hud og øjne, kløe, mørkfarvet urin, mavesmerter og ømhed i leveren (mærkes som smerter under forkanten af brystkassen), undertiden med appetitløshed.
English: • Patients and prescribers are reminded that the benefits of orlistat-containing medicines continue to outweigh the risks.
Danish: • Patienter og ordinerende læger gøres opmærksomme på, at fordelene ved orlistat fortsat overstiger risiciene.
English: Alli was authorised in 2007 and is available as capsules (60 mg) and chewable tablets (27 mg) which can be obtained without a prescription (‘over-the-counter').
Danish: Alli blev godkendt i 2007 og leveres som kapsler (60 mg) og tyggetabletter (27 mg), der udleveres uden recept (i håndkøb).
English: Overall, from 1997 to January 2011, 21 cases of severe liver toxicity were reported where Xenical was considered a possible cause, although other factors that could have caused the liver injury were present.
Danish: Samlet har der fra 1997 til januar 2011 været 21 tilfælde af svære leverskader, hvor Xenical blev anset for at være en mulig årsag, selv om der også var andre faktorer til stede, der kan have forårsaget leverskaderne.
English: There remains no clear evidence that orlistat causes these reactions.
Danish: Der er fortsat ingen klare beviser for, at det aktive stof er årsag til sådanne reaktioner.
English: The Committee concluded that the number of reported severe liver reactions in orlistat users was low and below the background rate expected in these people, given the large number of users.
Danish: Udvalget konkluderede, at antallet af indberettede alvorlige leverreaktioner hos brugere af orlistat var lavt, og at det var under den forventede baggrundsforekomst hos de pågældende, når det store antal brugere tages i betragtning.
English: • Patients who have any questions should speak to their doctor or pharmacist at a routine appointment.
Danish: • Patienter, der ønsker yderligere oplysninger, bør kontakte deres læge eller apotek.
English: The CHMP considered that there was no strong evidence that orlistat increased the risk of severe liver injury, and there was no known mechanism by which orlistat was expected to cause liver disorders.
Danish: CHMP fandt, at der ikke var stærke beviser for, at orlistat øger risikoen for alvorlige leverskader, og at der ikke var nogen kendt mekanisme, som giver formodning om, at orlistat kan forårsage leverlidelser.