FrancophonIA/ELRC3.0 huggingface dataset:
English: The Management Board re-elected Pat O'Mahony as its Chair for a new three-year term, by unanimous vote.
Danish: Bestyrelsen genvalgte enstemmigt Pat O'Mahony til formand for en ny treårig periode.
English: Members suggested that a questionnaire be prepared to gather and share information on what practices are put in place in NCAs with regards to the handing of conflicts of interest.
Danish: Medlemmerne foreslog, at der blev udarbejdet et spørgeskema for at indsamle og dele oplysninger om, hvilken praksis de nationale kompetente myndigheder anvendte med hensyn til håndtering af interessekonflikter.
English: Lessons learned during the volcanic eruption
Danish: Hovedpunkter Erfaringer fra vulkanudbruddet
English: Einar Magnússon (Iceland) Brigitte Batliner (Liechtenstein) Gro Ramsten Wesenberg (Norway)
Danish: Einar Magnússon (Island) Brigitte Batliner (Liechtenstein) Gro Ramsten Wesenberg (Norge)
English: The Board stressed that it is essential for the national competent authorities to recover the costs fully.
Danish: Bestyrelsen understregede, at det var af afgørende betydning, at de nationale kompetente myndigheder fik dækket alle omkostninger.
English: A further update will be provided in October.
Danish: En ny ajourføring ville følge i oktober.
English: Report from the European Commission
Danish: Rapport fra Europa-Kommissionen
English: [EMA/MB/210895/2010] The agenda was adopted with amendments to agenda item 14.
Danish: [EMA/MB/210895/2010] Dagsordenen blev vedtaget med ændringer af dagsordenspunkt 14.
English: The updated document will be presented at the HMA meeting in July and submitted to the Management Board for adoption by written procedure.
Danish: Det ajourførte dokument ville blive forelagt cheferne for de nationale lægemiddelstyrelser på mødet i juli og fremsendt til bestyrelsen til vedtagelse ved skriftlig procedure.
English: HMA supported the constitution of a permanent group of medical devices competent authorities.
Danish: Cheferne for de nationale lægemiddelstyrelser støttede nedsættelsen af en permanent gruppe af kompetente myndigheder inden for medicinsk udstyr.
English: The report will now be presented to the HMA in July and published on the Agency's website.
Danish: Rapporten ville nu blive forelagt cheferne for de nationale lægemiddelstyrelser i juli og offentliggjort på agenturets websted.
English: A workshop will be organised on 6-7 September 2010 as part of the consultation process, to which a wide range of EU and third-country regulators and stakeholders will be invited.
Danish: Der ville som led i høringsprocessen blive afholdt en workshop den 6.-7. september 2010, som en lang række myndigheder og interessenter fra EU og tredjelande ville blive inviteret til at deltage i. Bestyrelsen noterede sig den foreslåede dagsorden for workshoppen.
English: 10bis Appointment of Accounting Officer ad interim
Danish: 10bis Udnævnelse af midlertidig regnskabsfører
English: The HMA aims to complete the paper by the end of this year.
Danish: Cheferne for de nationale lægemiddelstyrelser stilede mod at færdiggøre dokumentet inden udgangen af indeværende år.
English: During its discussion, the Board reflected on the issue that a significant amount of work done by the national competent authorities is not compensated in the current fee system.
Danish: Under drøftelsen kom bestyrelsen ind på den omstændighed, at de nationale kompetente myndigheder udførte et stort stykke arbejde, som ikke blev godtgjort i forbindelse med den nuværende gebyrordning.
English: Providing such access demands significant resources for the Agency.
Danish: Det krævede betydelige ressourcer af agenturet at give en sådan aktindsigt.
English: The members noted the update report from the Heads of Medicines Agencies (HMA) on a number of topics, including:
Danish: Medlemmerne noterede sig den ajourførte rapport fra cheferne for de nationale lægemiddelstyrelser om en lang række emner, herunder:
English: [EMA/MB/302460/2010] The Management Board had adopted revised contractual arrangements which contain a number of key performance indicators.
Danish: [EMA/MB/302460/2010] Bestyrelsen havde vedtaget reviderede kontraktordninger, som indeholdt en række centrale resultatindikatorer.
English: • [EMEA/MB/298753/2010] Summary of transfers of appropriations in the budget 2010.
Danish: • [EMEA/MB/298753/2010] Sammendrag af bevillingsoverførsler på budgettet for 2010.
English: [EMA/MB/289198/2010] Pending the receipt of the opinion of the Court of Auditors on provisional accounts, a written procedure will be launched shortly to adopt the Management Board opinion on the Agency's annual accounts for the year ended 31 December 2009.
Danish: [EMA/MB/289198/2010] I afventning af Revisionsrettens udtalelse om det foreløbige årsregnskab ville der om kort tid blive indledt en skriftlig procedure med henblik på vedtagelse af bestyrelsens udtalelse om agenturets årsregnskab for det regnskabsår, der afsluttedes den 31. december 2009.
English: [EMA/MB/298741/2010] The Management Board discussed two ongoing consultation procedures: one for the CVMP and one for the CHMP.
Danish: [EMA/MB/298741/2010] Bestyrelsen drøftede to igangværende høringsprocedurer: én i forbindelse med CVMP og én i forbindelse med CHMP.
English: Held in London on 10 June 2010
Danish: møde i London den 10. juni 2010
English: The Vice-Chair continued to chair the meeting during the election process of the Management Board Chair.
Danish: Næstformanden forsatte som mødeformand under valget af bestyrelsesformand.
English: [EMA/MB/311466/2010] The Management Board discussed the memorandum of understanding (MoU) which clarifies the responsibilities between the EMA and national competent authorities for monitoring of the scientific level and independence of evaluations.
Danish: [EMA/MB/311466/2010] Bestyrelsen drøftede aftalememorandummet, som præciserede ansvaret mellem EMA og de nationale kompetente myndigheder med hensyn til overvågningen af det videnskabelige niveau og vurderingernes uafhængighed.
English: • Improving linkage between HMA and medical devices competent authorities.
Danish: • Forbedring af forbindelsen mellem cheferne for de nationale lægemiddelstyrelser og kompetente myndigheder inden for medicinsk udstyr.
English: Management Board meeting dates 2011
Danish: Bestyrelsesmødedatoer for 2011
English: • [EMA/MB/281850/2010] Outcome of written procedures during the period from 26 February 2010 to 2 June 2010.
Danish: • [EMA/MB/281850/2010] Resultat af skriftlige procedurer i perioden fra den 26. februar 2010 til den
English: European Commission
Danish: Europa-Kommissionen
English: [EMA/MB/297535/2010; EMA/MB/168222/2010] The Management Board adopted the analysis and assessment of the annual activity report 2009.
Danish: [EMA/MB/297535/2010; EMA/MB/168222/2010] Bestyrelsen vedtog analysen og vurderingen af årsberetningen for 2009.
English: List of participants at the 67
Danish: Liste over deltagere ved bestyrelsens 67.
English: Documents for information
Danish: Dokumenter til orientering
English: [EMA/MB/338709/2010; EMA/712397/2009] The Management Board noted the draft reflection paper, which elaborates on four areas of action from the strategy paper 'Acceptance of clinical trials conducted in third countries for evaluation in Marketing Authorisation Applications'.
Danish: [EMA/MB/338709/2010; EMA/712397/2009] Bestyrelsen noterede sig udkastet til arbejdsdokument, som uddybede fire indsatsområder fra strategidokumentet vedrørende accept af kliniske forsøg gennemført i tredjelande i forbindelse med vurdering af ansøgninger om markedsføringstilladelse.
English: Update on future accommodation of the Agency
Danish: Den seneste udvikling med hensyn til agenturets fremtidige lokaler
English: [EMA/MB/13787/2009] The Management Board noted the update report on the implementation of EudraVigilance for veterinary products.
Danish: [EMA/MB/13787/2009] Bestyrelsen noterede sig den ajourførte rapport om gennemførelsen af EudraVigilance for lægemidler til dyr.
English: [EMA/MB/345587/2010] The Management Board discussed the new format of the EudraVigilance report.
Danish: [EMA/MB/345587/2010] Bestyrelsen drøftede EudraVigilance-rapportens nye format.
English: [EMA/MB/298674/2010] The Management Board adopted its meeting dates for 2011 and noted tentative meeting dates for 2012.
Danish: [EMA/MB/298674/2010] Bestyrelsen vedtog mødedatoerne for 2011 og noterede sig foreløbige mødedatoer for 2012.
English: [EMA/MB/311343/2010; EMA/255244/2010; EMA/MB/353273/2010] The Management Board discussed and agreed in principle on a way forward for introducing changes to the way the Agency handles potential conflicts of interests of experts involved in the evaluation of medicines.
Danish: [EMA/MB/311343/2010; EMA/255244/2010; EMA/MB/353273/2010] Bestyrelsen drøftede og traf principbeslutning om, hvordan man kunne indføre ændringer af den måde, hvorpå agenturet håndterede eventuelle interessekonflikter hos eksperter, der deltog i vurderingen af lægemidler.
English: Human medicinal products
Danish: Lægemidler til mennesker
English: [EMA/MB/276960/2010; EMA/319831/2010] The Management Board noted the Agency's report to the European Commission providing the Agency's views on the experience with the Fee Regulation.
Danish: [EMA/MB/276960/2010; EMA/319831/2010] Bestyrelsen noterede sig agenturets rapport til EuropaKommissionen med angivelse af agenturets erfaringer med gebyrforordningen.
English: Report from the Heads of Medicines Agencies
Danish: Rapport fra cheferne for de nationale lægemiddelstyrelser
English: Election of the Management Board Chair
Danish: Valg af bestyrelsesformand
English: [EMA/MB/354158/2010] The Management Board endorsed the appointment of an ad interim accounting officer until the return to office of the accounting officer.
Danish: [EMA/MB/354158/2010] Bestyrelsen godkendte udnævnelsen af en midlertidig regnskabsfører indtil regnskabsførerens tilbagevenden til tjenesten.
English: [EMA/MB/372194/2010, EMA/MB/400828/2010] The Management Board noted the decision of the European Commission to re-open the vacancy announcement following advice of the European Commission legal service with regard to a wider publication of the vacancy.
Danish: [EMA/MB/372194/2010, EMA/MB/400828/2010] Bestyrelsen noterede sig Europa-Kommissionens beslutning om at genopslå stillingen efter rådgivning fra Europa-Kommissionens juridiske tjeneste med henblik på en bredere offentliggørelse af stillingsopslaget.
English: [EMA/MB/282448/2010] The Management Board heard the report on arbitration and referral activities of the CVMP.
Danish: [EMA/MB/282448/2010] Der blev aflagt rapport for bestyrelsen om CVMP's voldgifts- og henvisningsaktiviteter.
English: Representatives of patients' organisations
Danish: Repræsentanter for patientforeninger
English: Chair: Pat O'Mahony
Danish: Formand: Pat O'Mahony
English: Chairs of management boards of EU agencies
Danish: EU-agenturernes bestyrelsesformænd
English: Apologies
Danish: Afbud
English: • Agenda point 10_Advertisement of the vacancy notice for the recruitment of the Executive Director for the EMA.
Danish: • Dagsordenens punkt 10: Stillingsopslag med henblik på ansættelse af administrerende direktør i
English: Representative of veterinarians' organisations
Danish: Repræsentanter for dyrlægeorganisationer
English: Veterinary medicinal products
Danish: Lægemidler til dyr
English: The whole report can be found on the website of the Commission: http://ec.europa.eu/health/files/pharmacos/news/emea_final_report_vfrev2.pdf
Danish: Hele rapporten findes på Kommissionens websted: http://ec.europa.eu/health/files/pharmacos/news/emea_final_report_vfrev2.pdf Europa-Kommissionen og agenturet ville afholde en konference den 30. juni 2010 for at drøfte resultaterne af evalueringen med interessenter.
English: London, 10 June 2010
Danish: 2. juni 2010
English: Minutes of the 67th meeting of the Management Board
Danish: Referat af bestyrelsens 67.
English: [EMA/MB/194352/2010] The Management Board noted the final minutes, adopted by written procedure on 26 April 2010.
Danish: møde den 17.-18. marts 2010 [EMA/MB/194352/2010] Bestyrelsen noterede sig det endelige referat, der blev vedtaget gennem den skriftlige procedure den 26. april 2010.
English: Representative of doctors' organisations
Danish: Repræsentanter for lægeorganisationer
English: Kent Woods
Danish: Det Forenede Kongerige Kent Woods Europa-Parlamentet
English: • The progress on the HMA strategy paper.
Danish: • Fremskridt med strategidokumentet fra cheferne for de nationale lægemiddelstyrelser.
English: London, 22 October 2009 Doc.
Danish: London, den 22. oktober 2009 Dok.
English: However that trial was being stopped.
Danish: Denne undersøgelse var dog ved at blive stoppet.
English: It was expected to be available as tablets (50 and 150 mg).
Danish: Det forventedes at kunne fås som tabletter (50 og 150 mg).
English: What is Zunrisa?
Danish: Hvad er Zunrisa?
English: Questions and answers on the withdrawal of the marketing authorisation application for Zunrisa casopitant
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for Zunrisa casopitant
English: The effects of Zunrisa were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Zunrisa blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: If you are a patient in this trial and need more information about your treatment, contact the doctor who is treating you.
Danish: Hvis du deltager i en klinisk undersøgelse og har behov for yderligere oplysninger om din behandling, bedes du kontakte den læge, der giver dig behandlingen.
English: When substance P attaches to these receptors, it can cause nausea and vomiting.
Danish: Når substans P binder sig til disse receptorer, kan det forårsage kvalme og opkastninger.
English: Zunrisa is a medicine that contains the active substance casopitant.
Danish: Zunrisa er et lægemiddel, der indeholder det aktive stof casopitant.
English: The active substance in Zunrisa, casopitant, is a ‘neurokinin 1 (NK1) receptor antagonist'.
Danish: Det aktive stof i Zunrisa, casopitant, er en neurokinin-1-(NK1)-receptorantagonist.
English: What was Zunrisa expected to be used for?
Danish: Hvad forventedes Zunrisa anvendt til?
English: The Committee also asked the company to reconsider the target population for patients having surgery to ensure it adequately reflected the kind of patients who were involved in the studies.
Danish: Udvalget bad også virksomheden om at genoverveje målpopulationen for patienter, der bliver opereret, for at sikre, at den i tilstrækkelig grad afspejler den type patienter, som deltog i undersøgelserne.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues.
Danish: Efter at CHMP havde vurderet virksomhedens besvarelse af spørgsmålene på listen, var der fortsat visse uafklarede spørgsmål.
English: How is Zunrisa expected to work?
Danish: Hvordan forventes Zunrisa at virke?
English: It blocks a chemical in the body called substance P from attaching to the NK1 receptors.
Danish: Det forhindrer et stof i kroppen, der kaldes substans P, i at binde sig til NK1-receptorerne.
English: The patients received Zunrisa with ondansetron or ondansetron alone.
Danish: Patienterne fik Zunrisa sammen med ondansetron eller ondansetron alene.
English: The company presented data from large studies in cancer patients receiving chemotherapy.
Danish: Virksomheden fremlagde data fra omfattende undersøgelser af kræftpatienter, der får kemoterapi.
English: The company informed the CHMP that at the time of the withdrawal one clinical trial with Zunrisa was ongoing.
Danish: Virksomheden informerede CHMP om, at der på det tidspunkt, hvor tilbagetrækningen fandt sted, var en klinisk undersøgelse med Zunrisa under gennemførelse.
English: The patients were given a combination of Zunrisa with two other medicines (dexamethasone and ondansetron) or the combination without Zunrisa.
Danish: Patienterne fik en kombination af Zunrisa og to andre lægemidler (dexamethason og ondansetron), eller også fik de denne kombination uden Zunrisa.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Zunrisa?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Zunrisa eller i programmer for anvendelse af Zunrisa med særlig udleveringstilladelse?
English: On 25 September 2009, Glaxo Group Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zunrisa, for the prevention of nausea and vomiting in patients undergoing surgery or receiving chemotherapy.
Danish: Den 25. september 2009 meddelte Glaxo Group Ltd officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Zunrisa til forebyggelse af kvalme og opkastninger hos patienter, der bliver opereret eller får kemoterapi.
English: The company also presented data from studies in patients at a high risk of having nausea and vomiting after surgery.
Danish: Virksomheden fremlagde ligeledes data fra undersøgelser af patienter, som havde høj risiko for at få kvalme og opkastninger efter en operation.
English: The main measure of effectiveness for the study was the number of patients who did not vomit or needed to be given any rescue medication in the first 24 hours after surgery.
Danish: Det primære effektmål for undersøgelsen var det antal patienter, der ikke kastede op eller havde brug for et hurtigt virkende lægemiddel inden for de første 24 timer efter operationen.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Zunrisa could not have been approved for use with other medicines in the prevention of nausea and vomiting in patients receiving chemotherapy or in those undergoing surgery.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Zunrisa ikke kunne have været godkendt til brug sammen med andre lægemidler med henblik på forebyggelse af kvalme og opkastninger hos patienter, der får kemoterapi eller bliver opereret.
English: The main measure of effectiveness was the number of patients who did not vomit or needed to be given rescue medication for vomiting in the first five days following the start of a cycle of chemotherapy.
Danish: Det primære effektmål var antallet af patienter, som ikke kastede op eller havde brug for at få et hurtigt virkende lægemiddel mod opkastninger i de første fem dage efter starten på en kemoterapicyklus.
English: By blocking the receptors, casopitant was expected to prevent nausea and vomiting which often happens during chemotherapy or as a complication of surgery.
Danish: Det forventedes, at casopitant ved at blokere disse receptorer ville forhindre kvalme og opkastninger, som ofte optræder under kemoterapi eller som komplikation ved operation.
English: Zunrisa was expected to be used in combination with other medicines to prevent nausea and vomiting in patients receiving chemotherapy treatments (medicines to treat cancer) that are moderate or strong triggers of nausea and vomiting.
Danish: Zunrisa forventedes anvendt i kombination med andre lægemidler for at forebygge kvalme og opkastning hos patienter, der får kemoterapi (lægemidler til behandling af kræft), som i moderat eller svær grad udløser kvalme og opkastninger.
English: Zunrisa was also expected to be used with other medicines to prevent nausea and vomiting in patients undergoing surgery.
Danish: Zunrisa forventedes ligeledes anvendt sammen med andre lægemidler for at forebygge kvalme og opkastninger hos patienter, der bliver opereret.
English: After looking at the results of the main studies, the CHMP noted that, while the studies showed that Zunrisa was effective in some cancer patients receiving chemotherapy, its use in patients receiving chemotherapy treatments that are moderate triggers of nausea and vomiting was not fully supported by the results.
Danish: Efter at have set på resultaterne af hovedundersøgelserne bemærkede CHMP, at brugen af Zunrisa hos patienter, som fik kemoterapi, der i moderat grad forårsager kvalme og opkastninger, ikke var fuldt ud underbygget af resultaterne, selv om undersøgelserne viste, at Zunrisa var effektiv hos nogle kræftpatienter, der fik kemoterapi.
English: VIANI DISKUS and associated names (See Annex I)
Danish: VIANI DISKUS og tilknyttede navne (se bilag I)
English: Page 2/2 ©EMEA 2007
Danish: Side 2/2 ©EMEA 2007
English: International Non-Proprietary Name (INN): salmeterol / fluticasone
Danish: Internationalt fællesnavn (INN): salmeterol / fluticason
English: The final opinion was converted into a Decision by the European Commission on 4 July 2006.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 4. juli
English: The referral procedure started on 19 September 2005.
Danish: Proceduren for indbragte sager blev indledt den 19. september 2005.
English: The Rapporteur and Co-Rapporteur appointed were Dr D Lyons and Dr G Calvo Rojas, respectively.
Danish: Den udpegede rapportør og medrapportør var henholdsvis dr. D. Lyons og dr. G. Calvo Rojas.
English: In the MRP Sweden is the Reference Member State (RMS) and Austria, Belgium, Finland, France, Germany, Italy, Ireland, Luxembourg, Portugal, Spain and the United Kingdom are Concerned Member States (CMS).
Danish: I proceduren for gensidig anerkendelse er Sverige referencemedlemsstaten, og Østrig, Belgien, Finland, Frankrig, Tyskland, Italien, Irland, Luxembourg, Portugal, Spanien og Det Forenede Kongerige er de berørte medlemsstater.
English: BACKGROUND INFORMATION
Danish: BAGGRUND
English: PERSUANT TO ARTICLE 6(13) OF COMMISSSION REGULATION (EC) No 1084/2003 FOR
Danish: I HENHOLD TIL ARTIKEL 6, STK. 13, I KOMMISSIONENS FORORDNING (EF) NR. 1084/2003 FOR
English: SUMMARY INFORMATION ON REFERRAL OPINION
Danish: SAMMENFATTENDE OPLYSNINGER OM UDTALELSEN OM DEN INDBRAGTE SAG
English: *Note: the information given in this document and Annexes reflect only the CHMP Opinion dated 27 April 2006.
Danish: Bemærkning: Oplysningerne i dette dokument og bilagene afspejler udelukkende CHMP's udtalelse af 27. april 2006.
English: On 12 August 2005 the Marketing Authorisation Holders presented to the EMEA a referral under article 6(13) of Commission Regulation (EC) No 1084/2003.
Danish: Indehaverne af markedsføringstilladelserne indbragte den 12. august 2005 en sag for EMEA i henhold til artikel 6, stk. 13, i Kommissionens forordning (EF) nr. 1084/2003.
English: Supplementary information was provided by the Marketing Authorisation Holders on 3 February 2006 and written explanations were given on 30 March 2006.
Danish: Indehaverne af markedsføringstilladelserne fremsendte supplerende oplysninger den 3. februar 2006 og skriftlige redegørelser den 30. marts 2006.