FrancophonIA/ELRC3.0 huggingface dataset:
English: The company presented the results of two main studies involving 12 boys aged 7 to 13 years with DMD who had a genetic mutation amenable to exon 51 skipping.
Danish: Virksomheden fremlagde resultaterne fra to hovedstudier af 12 drenge i alderen 7-13 år med DMD, som havde en genetisk mutation, der var modtagelig over for exon 51 skipping-teknologien.
English: Patients with DMD do not produce a protein called dystrophin.
Danish: Patienter med DMD producerer ikke proteinet dystrofin.
English: The medicine allows exon 51 to be skipped over and so promote the production of a shortened form of dystrophin.
Danish: Lægemidlet gør det muligt at udelade exon 51gensegmentet og dermed fremme produktionen af en afkortet form af dystrofin.
English: After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 20 September 2018.
Danish: CHMP gennemgik begrundelsen for anmodningen og revurderede udtalelsen, og bekræftede den 20. september 2018 afslaget på ansøgningen om markedsføringstilladelse.
English: This means that the patients' DMD gene can make a working form of the dystrophin protein when a part of the gene called exon 51 is not used.
Danish: Det betyder, at patienternes DMD-gen kan danne en fungerende form af proteinet dystrofin, når en del af det såkaldte exon 51-gensegment ikke anvendes.
English: The main measure of effectiveness was the change in the distance walked during a 6-minute walking test after 24 weeks.
Danish: Virkningen blev hovedsageligt målt på ændringen i den distance, patienterne kunne gå i en 6-minutters gangtest efter 24 uger.
English: In the first study, Exondys was compared with placebo (a dummy treatment) for the first 24 weeks, after which all patients were treated with Exondys.
Danish: I det første studie blev Exondys sammenlignet med placebo (et ikke-aktivt stof) i de første 24 uger, hvorefter alle patienterne blev behandlet med Exondys.
English: Exondys was expected to be used for treating Duchenne muscular dystrophy (DMD) in patients aged from 4 years with mutation (change) in the DMD gene that allows treatment involving ‘exon 51 skipping'.
Danish: Exondys skulle anvendes til behandling af Duchennes muskeldystrofi (DMD) hos patienter i alderen fra 4 år og opefter med en mutation (forandring) i DMD-genet, der muliggør behandling med den såkaldte exon 51 skipping-teknologi.
English: It was to be available as a concentrate for solution for infusion (drip) into a vein.
Danish: Det skulle markedsføres som et koncentrat til infusionsvæske til indgivelse gennem et drop i en vene.
English: How does Exondys work?
Danish: Hvordan virker Exondys?
English: The financial impact of the scheme was in excess of € 140,000.
Danish: Ordningens finansielle virkning lå på over 140.000 EUR.
English: The draft conclusions concern the issue of relative effectiveness.
Danish: Forslaget til konklusioner vedrørte spørgsmålet om relativ effektivitet.
English: The workshop was successful with 170 delegates from around 50 countries attending.
Danish: Workshoppen var en succes med deltagelse af 170 repræsentanter fra omkring 50 lande.
English: All bodies which had a role in responding to the pandemic participated.
Danish: Alle organer, der spillede en rolle i forbindelse med pandemiens bekæmpelse, deltog.
English: The policy will be published in November 2010.
Danish: Politikken vil blive offentliggjort i november 2010.
English: The European Commission is seeking a solution for the support and coordination of the EU level tasks.
Danish: Europa-Kommissionen søger en løsning til støtte for og koordinering af opgaverne på EU-plan.
English: Minor Use Minor Species policy: Annual report 2010
Danish: Minor Use Minor Species-politik: Årsberetning 2010
English: The traceability is a complex issue, particularly for medicinal products due to their wide distribution.
Danish: Sporbarhed er et komplekst emne, især for lægemidler som følge af deres vidtrækkende distribution.
English: The existing and new responsibilities, notably the new responsibilities in the field of pharmacovigilance, will increase pressure on financial resources.
Danish: De eksisterende og nye ansvarsområder, navnlig de nye ansvarsområder inden for lægemiddelovervågning, vil øge presset på de finansielle ressourcer.
English: The European Commission already gave its agreement to the draft policy in accordance with Article 110 of the Staff Regulations.
Danish: Europa-Kommissionen havde allerede givet sit samtykke til udkastet til denne strategi i henhold til artikel 110 i vedtægten for tjenestemænd.
English: It was also put forward that a world-wide arrangement could be envisaged, e.g. within the context of ICH.
Danish: Det blev endvidere fremført, at man kunne overveje at indføre en ordning på verdensplan, f.eks. inden for rammerne af ICH.
English: • The adoption of the draft Strategy Paper II 2011-2015 for public consultation.
Danish: • Vedtagelse af udkastet til strategidokument II 2011-2015 til offentlig høring.
English: The Agency's revenue and expenditure for 2010 are also on target.
Danish: Agenturets indtægter og udgifter for 2010 var også på rette spor.
English: The Committee for Medicinal Products for Human Use recommended the suspension of Avandia.
Danish: Udvalget for Humanmedicinske Lægemidler havde anbefalet at suspendere Avandia.
English: All three concerned parties - European Commission, ECDC and EMA - have been working together to propose a solution.
Danish: Alle tre berørte parter - Europa-Kommissionen, ECDC og EMA - har arbejdet sammen om at finde en løsning.
English: EU legislation on Substances of Human Origin sets out responsibilities for the EU Member States and the Commission in this area.
Danish: EU-lovgivningen om stoffer af menneskelig oprindelse fastlægger ansvarsfordelingen mellem EUmedlemsstaterne og Kommissionen på dette område.
English: The regulation replaces the version provisionally adopted by the Board on 11 December 2008.
Danish: Forordningen erstatter den udgave, der blev midlertidigt vedtaget af bestyrelsen den 11. december 2008.
English: The new policy is built with three principles in mind: robustness, efficiency and transparency.
Danish: Den nye strategi er baseret på tre principper, nemlig stabilitet, effektivitet og gennemsigtighed.
English: The political process to examine the fee system will be lengthy and therefore it is important to proceed as soon as possible and envisage interim solutions.
Danish: Den politiske procedure med undersøgelse af gebyrordningen vil blive langvarig, og det er derfor vigtigt at komme i gang hurtigst muligt og overveje midlertidige løsninger.
English: The Agency demonstrated good performance against objectives set in the work programme.
Danish: Agenturet udviste gode resultater i forhold til de mål, der var fastsat i arbejdsprogrammet.
English: This practice reflected well on both agencies and needs to be maintained in future.
Danish: Denne fremgangsmåde kastede et positivt lys over begge agenturer og skal opretholdes i fremtiden.
English: Preparation for written procedure on adoption of the Agency's policy on protecting the dignity of the person and preventing any form of psychological or sexual harassment
Danish: Forberedelse af en skriftlig procedure om vedtagelse af agenturets strategi for beskyttelse af den personlige værdighed og forhindring af enhver form for psykisk og seksuel chikane
English: The European Commission anticipates that an extraordinary meeting can be convened for the last week of February 2011.
Danish: Europa-Kommissionen forventede, at der muligvis vil blive indkaldt til et ekstraordinært møde i sidste uge af februar 2011.
English: The Board will review an interim report on experience with the revised policy in 6 months time and a full report in 18-24 months time.
Danish: Bestyrelsen vil gennemgå en midlertidig rapport om erfaringerne med den reviderede strategi om seks måneder og en fuldstændig rapport om 18-24 måneder.
English: • Wider application of teleconferencing tools involving larger number of participants.
Danish: • Mere udbredt anvendelse af telekonferenceværktøjer i forbindelse med møder med et større antal deltagere.
English: The endorsed document follows the public consultation launched in December 2008 and takes into account recommendations from the European Ombudsman.
Danish: Det godkendte dokument fulgte efter den offentlige høring, der blev indledt i december 2008, og tog højde for Den Europæiske Ombudsmands henstillinger.
English: The amendment takes into account the size of the Agency and specialisation of staff.
Danish: Ændringen tog højde for agenturets størrelse og personalets specialisering.
English: 9bis Transfer of appropriations in the budget 2010 in accordance with Article 23 (2) of the Financial Regulation
Danish: Bevillingsoverførsler på budgettet for 2010 i henhold til finansforordningens artikel 23, stk. 2
English: The role of patients and consumers in the different scientific committees of the Agency will also be defined.
Danish: Patienternes og forbrugernes rolle i agenturets forskellige videnskabelige udvalg vil også blive fastlagt.
English: The policy will be implemented in the second quarter of 2011 once practical arrangements have been put in place.
Danish: Strategien vil blive indført i andet kvartal af 2011, når de praktiske aspekter er kommet på plads.
English: A further discussion will take place at the December meeting.
Danish: Emnet vil blive drøftet igen på decembermødet.
English: • Revision of the clinical trials directive.
Danish: • Revision af direktivet om kliniske forsøg.
English: Proposed changes will be introduced and the report will be published on the website.
Danish: De foreslåede ændringer vil blive indføjet, og rapporten vil blive offentliggjort på webstedet.
English: European Commission initiative on vigilance of substances of human origin
Danish: Europa-Kommissionens initiativ vedrørende et overvågningssystem for stoffer af menneskelig oprindelse
English: The fee system should be re-examined to assure appropriate financing of the Agency and the network.
Danish: Gebyrordningen bør tages under fornyet behandling for at sikre tilstrækkelig finansiering af agenturet og netværket.
English: The new EMA Financial Regulation follows the revision of the Framework Financial Regulation (EC, EURATOM) No 2343/2002 in 2008 and takes into account comments made by the European Commission.
Danish: Den nye finansforordning for EMA fulgte efter revisionen af rammefinansforordningen (EF, Euratom) nr. 2343/2002 i 2008 og tog højde for de af Europa-Kommissionen fremsatte bemærkninger.
English: The rules come into effect on 7 October 2010 and will be published on the Agency's website.
Danish: Bestemmelserne skal træde i kraft den 7. oktober 2010 og vil blive offentliggjort på agenturets websted.
English: The members noted the update report from the European Commission on a range of topics, including:
Danish: Medlemmerne noterede sig den ajourførte rapport fra Europa-Kommissionen om en lang række emner, herunder:
English: The Board also endorsed the publication of the meeting document with a few amendments.
Danish: Bestyrelsen godkendte endvidere offentliggørelsen af mødedokumentet med enkelte ændringer.
English: It is anticipated that the first meeting of the group will take place towards the end of 2010 or in early 2011.
Danish: Det forventedes, at gruppens første møde vil finde sted i slutningen af 2010 eller i starten af 2011.
English: As experience is gathered, the CVMP may need to further clarify the borderline between MUMS and other products.
Danish: I takt med de indhøstede erfaringer kan CVMP blive nødt til at klarlægge grænsen mellem MUMS og andre produkter.
English: This aim can be achieved in the context of the transparency policy and the implementation of the pharmacovigilance legislation.
Danish: Dette mål vil kunne nås i kraft af gennemsigtighedsstrategien og gennemførelsen af lægemiddelovervågningslovgivningen.
English: The released part of the provisional appropriation will be used to finance and bring forward ICT projects that might be insufficiently financed in 2011 due to reductions in the EU contribution for 2011.
Danish: Den frigivne del af den formålsbestemte reserve vil blive anvendt til at finansiere og sætte skub i ICT-projekter, der risikerer at modtage utilstrækkelig finansiering i 2011 som følge af nedgangen i EU's bidrag i 2011.
English: The amendment concerns the replacement of mandatory mobility with ex-post controls and/or focused audits every two years for sensitive functions.
Danish: Ændringen vedrørte erstatningen af obligatorisk mobilitet med ex post-kontroller og/eller målrettet revision hvert andet år i forbindelse med følsomme stillinger.
English: The EMA's involvement in this process relates to the fact that a part of substances of human origin are processed to advanced therapies, which are then covered by specific legislation.
Danish: EMA's inddragelse i denne proces skyldes, at en del af stofferne af menneskelig oprindelse forarbejdes til avancerede terapier, som er omfattet af specifik lovgivning.
English: The transfer follows the evaluation of its budgetary situations as at 31 August 2010 which showed favourable budget trend.
Danish: Overførslen fulgte efter evalueringen af agenturets budgetmæssige situation pr. 31. august 2010, som udviste en favorabel budgettendens.
English: Revision of EMA Financial Regulation and its Implementing Rules
Danish: Revision af finansforordningen for EMA og dens gennemførelsesbestemmelser
English: Draft agenda for 7 October 2010 meeting
Danish: Forslag til dagsorden for mødet den 7. oktober 2010
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.
Danish: Der vil blive udarbejdet en rapport om en løsning på operationelt plan efter disse drøftelser, og den vil blive forelagt ECDC's og EMA's bestyrelser i henholdsvis november og december 2010.
English: The Agency anticipates that the EU contribution for the Agency will not increase and is likely to decrease as a proportion of the Agency's budget.
Danish: Agenturet regnede med, at EU's bidrag til agenturet ikke vil stige, og at dets andel af agenturets budget sandsynligvis vil falde.
English: By introducing the new policy, the Agency aims to ensure the widest possible access to its documents whilst respecting a number of principles set out in the policy, including the protection of commercial confidential information and personal data.
Danish: Med indførelsen af den nye politik agtede agenturet i videst muligt omfang at sikre adgang til dets dokumenter under overholdelse af en række principper, som fastsættes i politikken, herunder beskyttelse af kommercielt fortrolige oplysninger og personoplysninger.
English: It was emphasised that the same principles are applied for all experts, those from national authorities, academia and civil society representatives, working in the EMA's committees.
Danish: Det blev understreget, at det er de samme principper, der gælder for alle eksperter - eksperter fra de nationale myndigheder, den akademiske verdens og civilsamfundets repræsentanter - som arbejder i EMA's udvalg.
English: The Board noted that the conclusions in the HAI report are based only on information found on the internet.
Danish: Bestyrelsen noterede sig, at konklusionerne i HAI-rapporten udelukkende var baseret på oplysninger fundet på internettet.
English: Sponsoring of patients' organisations by pharmaceutical industry - proposed actions
Danish: Lægemiddelindustriens sponsorering af patientorganisationer - foreslåede tiltag
English: The management were satisfied that both the Agency and the US Food and Drug Administration cooperated in this matter and made a coordinated announcement of respective decisions.
Danish: Ledelsen konstaterede med tilfredshed, at agenturet og de amerikanske sundhedsmyndigheder, The Food and Drug Administration, havde arbejdet sammen i denne sag og var kommet med en koordineret meddelelse om deres respektive beslutninger.
English: It aims at balancing out the need to secure Europe's best scientific experts for the evaluation and supervision of medicines while ensuring that these experts have no financial or other interests in the pharmaceutical industry that could affect their impartiality.
Danish: Den har til formål at skabe balance mellem behovet for at sikre sig Europas bedste videnskabelige eksperter til vurdering og overvågning af lægemidler og samtidig sikre sig, at disse eksperter ikke har hverken finansielle eller andre interesser i lægemiddelindustrien, der kan påvirke deres upartiskhed.
English: The financial and workload impact of the scheme and the Agency's and the network's ability to respond will continue to be monitored and reviewed if needed.
Danish: Ordningens finansielle virkning, dens indvirkning på arbejdsbyrden og agenturets og netværkets reaktionsevne vil fortsat blive overvåget og om nødvendigt revideret.
English: The effects of the policy will be monitored and further changes introduced as needed.
Danish: Strategiens virkninger vil blive overvåget, og yderligere ændringer vil blive indført efter behov.
English: The current Executive Director will make the appointment.
Danish: Den nuværende administrerende direktør vil forestå udnævnelsen.
English: The establishment of a Joint CVMP/CHMP ad-hoc Expert Group on the application of the 3Rs (Replacement, Reduction and Refinement) in the development of medicinal products
Danish: Nedsættelse af en fælles CVMP/CHMP-ad hoc-ekspertgruppe vedrørende anvendelsen af 3R-princippet (Replacement, Reduction, Refinement) i udviklingen af lægemidler
English: The latter outlines how principles set out in the policy will be interpreted.
Danish: Dokumentet beskrev, hvordan politikkens principper vil blive fortolket.
English: • Draft Council conclusions on Innovation and Solidarity in the Pharmaceutical Sector prepared by the Presidency
Danish: • Forslag til Rådets konklusioner om innovation og solidaritet i lægemiddelsektoren udarbejdet af formandskabet
English: Amendment to the Agency's internal control standard on sensitive functions
Danish: 10. Ændring af agenturets interne kontrolstandard vedrørende følsomme stillinger
English: The Agency receives financial statements of each of the organisations during the evaluation of their eligibility to work with the EMA.
Danish: Agenturet modtager årsregnskaber fra samtlige organisationer i forbindelse med vurderingen af deres berettigelse til at arbejde sammen med EMA.
English: The meeting also considered future interactions between the two groups and a concept of performance indicators applicable to members of a management board.
Danish: På mødet overvejede man ligeledes det fremtidige samspil mellem de to grupper og en idé om resultatindikatorer for medlemmer af en bestyrelse.
English: The Board discussed that due to the nature of the Agency's operations any future options should provide for a maximum degree of flexibility for expansion or reduction.
Danish: Bestyrelsen argumenterede for, at som følge af arten af agenturets aktiviteter skulle alle fremtidige muligheder give en maksimal grad af fleksibilitet med hensyn til personaleforøgelse eller -nedgang.
English: Product suspension
Danish: Suspendering af produkter
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.
Danish: I beretningen konkluderedes det, at den nye ordning opfyldte målet om at fremme udviklingen af og udstedelsen af tilladelser til nye MUMS-veterinærlægemidler.
English: The Agency will meet with patients/consumers' and healthcare professionals' representatives to explain how the policy will be applied.
Danish: Agenturet vil mødes med repræsentanter for patienter/forbrugere og sundhedspersonale og forklare, hvordan strategien vil blive gennemført.
English: The European Commission had been informed of the proposal.
Danish: Europa-Kommissionen var blevet underrettet om dette forslag.
English: There should be an EU level interconnectivity between these areas to ensure a comprehensive approach to vigilance and traceability of products.
Danish: Der bør på europæisk plan skabes en indbyrdes forbindelse mellem disse områder for at sikre en samlet tilgang til produktovervågning ogsporbarhed.
English: The last meeting of the group discussed the ongoing inter-institutional review of the EU agencies with the participation of the chair of the EU executive directors group.
Danish: På det seneste møde mellem formændene drøftede man den igangværende interinstitutionelle revision af EU-agenturerne med deltagelse af formanden for EU's gruppe af administrerende direktører.
English: Kent Woods, the Board's observer in the Commission part of the selection process, together with a few members will prepare questions for the interview, assuring that the selection criteria were adequately explored.
Danish: Kent Woods, bestyrelsens observatør under Kommissionens del af udvælgelsesproceduren, vil sammen med et par medlemmer udarbejde spørgsmål til samtalen, som sikrer en passende hensyntagen til udvælgelseskriterierne.
English: The Management Board discussed ways to establish closer relation between the Committee and the Management Board.
Danish: Bestyrelsen drøftede måder, hvorpå man kunne skabe tættere forbindelser mellem udvalget og bestyrelsen.
English: • The preparation for the third cycle of Benchmarking of European Medicines Agencies and endorsement of its continuation.
Danish: • Forberedelse af tredje runde af fastsættelsen af referenceværdier for de europæiske lægemiddelstyrelser og godkendelse af dens fortsættelse.
English: The Board nominated the vice-chair, Lisette Tiddens-Engwirda, as the Board representative to the Committee.
Danish: Bestyrelsen udnævnte næstformand Lisette Tiddens-Engwirda som bestyrelsens repræsentant i udvalget.
English: The work has started whereby the Agency has communicated its experience of the fee system to the European Commission and presented the topic to its stakeholders at the conference in June 2010.
Danish: Agenturet har indledt dette arbejde, idet det har underrettet Europa-Kommissionen om dets erfaringer med gebyrordningen og har forelagt emnet for agenturets interessenter på konferencen i juni 2010.
English: The Agency held an international workshop, on 6-7 September 2010 as part of the public consultation on the draft Reflection paper on GCP and ethical requirements for clinical trials conducted in third countries and submitted in marketing authorisation applications to the Centralised Procedure.
Danish: Agenturet afholdt en international workshop den 6.-7. september 2010 som led i den offentlige høring om udkastet til arbejdsdokument om GCP-aspekter og etiske aspekter ved kliniske forsøg, der gennemføres i tredjelande og er indeholdt i ansøgninger om markedsføringstilladelse i forbindelse med den centraliserede procedure.
English: EMA Mid-year report 2010
Danish: EMA's halvårsrapport 2010
English: However, to further increase transparency in the area, the Board endorsed the proposal to make further improvements in related procedures and suggested including links to the websites of the concerned organisations to enable easier consultation by the public.
Danish: For yderligere at øge gennemsigtigheden på området godkendte bestyrelsen imidlertid forslaget om at foretage yderligere forbedringer af procedurerne og foreslog, at der blev medtaget links til de pågældende organisationers websteder for at gøre det lettere for offentligheden at indhente oplysninger om dem.
English: The group will contribute to the work aiming to encourage the development and regulatory acceptance of alternative approaches to animal testing, will reinforce the role of the Agency in the area of animal welfare and will facilitate communication with stakeholders.
Danish: Gruppen skal bidrage til det arbejde, der har til formål at fremme udviklingen og den lovgivningsmæssige accept af alternativer til dyreforsøg, styrke agenturets rolle inden for området dyrevelfærd og lette kommunikationen med interessenterne.