FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency will consider this information in the context of the ongoing revision of the Agency's policy governing the handling of conflicts of interest and will inform the corresponding parties accordingly.
Danish: Agenturet ville overveje disse oplysninger i forbindelse med den løbende gennemgang af agenturets politik for håndtering af interessekonflikter og ville informere parterne i overensstemmelse hermed.
English: The proposal also links to the ongoing work at HMA-EMEA level, where a joint training team looks into a strategy aimed at further enhancing skills of the regulators.
Danish: Forslaget skulle også hænge sammen med det arbejde, der blev udført på HMA-EMEA-niveau, hvor et fælles uddannelsesudvalg arbejdede med en strategi, som yderligere skulle forbedre myndighedernes kvalifikationer.
English: The CHMP has provided an explanatory note about the rationale for benefit-risk assessment of the vaccines, and published the information on the Agency's website.
Danish: CHMP havde fremsendt en forklarende note om begrundelsen for en vurdering af fordele/risici ved vaccinerne og offentliggjort oplysningerne på agenturets websted.
English: The Management Board wrote to the Commission regarding this issue in June and provided a response to the European Commission's letter in August.
Danish: Bestyrelsen skrev til Europa-Kommissionen om dette spørgsmål i juni og besvarede dens brev i august.
English: A proposed framework on the interaction with HCPs' organisations will be discussed at the October meeting of the working group.
Danish: Et forslag til rammer om samspil med sundhedsmedarbejderorganisationer ville blive drøftet på arbejdsgruppens møde i oktober.
English: The letter informed the Board, inter alia, that these persons were members of an editorial team for a book, which was sponsored by a pharmaceutical company.
Danish: Det fremgik bl.a. af brevet, at de pågældende var medlem af et redaktionshold bag en bog, som var sponsoreret af en lægemiddelvirksomhed.
English: The proposal should be finalised for the March 2010 Management Board meeting.
Danish: Det endelige forslag ville foreligge til bestyrelsens møde i marts 2010.
English: Lisette Tiddens-Engwirda was nominated as chair of the committee.
Danish: Lisette Tiddens-Engwirda blev valgt til formand.
English: A reflection paper, which will be presented at the December meeting, will provide proposals on further involvement of patients' and consumers' organisations in the Agency's activities, including in the scientific review process.
Danish: Et arbejdsdokument, som ville blive fremlagt på mødet i december, ville indeholde forslag til yderligere inddragelse af patient- og forbrugerorganisationer i agenturets aktiviteter, herunder den videnskabelige revisionsproces.
English: This topic will be addressed during the future review of the Fee Regulation.
Danish: Spørgsmålet ville blive drøftet i forbindelse med den næste revision af gebyrforordningen.
English: It was asked that for future versions of the telematics master plan the document should be tabled with track changes for a more easy comparison with previous versions.
Danish: For fremtidige udgaver af telematikmasterplanen bad man om at få forelagt dokumentet med "vis ændringer", således at det blev lettere at sammenligne med tidligere udgaver.
English: Some deviations from the work programme were recorded, relating to the number and complexity of referrals in the veterinary field, which requires significant scientific resources, and to lower-thanplanned productivity of the Committee on Herbal Medicinal Products (HMPC).
Danish: Der var konstateret nogle afvigelser fra arbejdsprogrammet i relation til antallet og kompleksiteten af henvisninger på veterinærområdet, hvilket krævede betydelige videnskabelige ressourcer, og til Udvalget for Plantelægemidlers produktivitet, som var lavere end forventet.
English: Mandate of the Ad Hoc Pharmacovigilance Inspectors Working Group
Danish: Mandat til ad hoc-arbejdsgruppen for lægemiddelovervågningsinspektører
English: The authority will be informed about the concerns expressed by the Board with regards to the suitability of the nominee.
Danish: Myndigheden ville blive informeret om bestyrelsens bekymringer vedrørende den udnævntes egnethed.
English: Amendments to the CV template for experts and to the EMEA letter inviting nominations were introduced.
Danish: Der blev indført ændringer i cv-modellen for eksperter og i EMEA's brev om udnævnelser.
English: The members noted the update report from the European Commission on a range of topics, including: the European Commission's work in the field of pandemic influenza, progress on the inter-service consultation on the variations regulation, the entry into force of the new regulation on maximum residue limits, and work in the field of health technology assessment.
Danish: Medlemmerne noterede sig den ajourførte rapport fra Europa-Kommissionen om en lang række emner: Europa-Kommissionens arbejde med pandemisk influenza, fremskridt med høringen af tjenestegrene om de forskellige forordninger, ikrafttrædelsen af den ny forordning om maksimale restkoncentrationer og arbejdet med vurderingen af sundhedsteknologi.
English: The Agency is now preparing a report based on the data received, and will submit the report to the December Management Board meeting, at which time the Board will also be able to discuss options for a possible decision in the future.
Danish: Agenturet udarbejdede nu en rapport på baggrund af disse data og ville indsende den til bestyrelsens møde i december, hvor denne også kunne drøfte mulighederne for at få truffet en beslutning.
English: The Management Board discussed that currently there is a lot of duplication in the area of health technology assessment (HTA) among Member States.
Danish: Bestyrelsen drøftede problemet med, at der p.t. foregik en masse dobbeltarbejde vedrørende vurderinger af sundhedsteknologi i medlemsstaterne.
English: The procedure will enable the Agency to inform the nominating authority of a potential conflict of interests of a nominee at the start of the nomination procedure.
Danish: Proceduren ville sætte agenturet i stand til at informere den udnævnende myndighed om en eventuel interessekonflikt i begyndelsen af udnævnelsesproceduren.
English: [EMEA/MB/518171/2009] The Board adopted the following meeting dates for 2010: 17 and 18 March, 10 June, 7 October and 16 December.
Danish: [EMEA/MB/518171/2009] Bestyrelsen vedtog følgende mødedatoer for 2010: 17. og 18. marts, 10. juni, 7. oktober og 16. december.
English: The mandate has been endorsed by the Heads of Medicines Agencies.
Danish: Mandatet var blevet godkendt af cheferne for de nationale lægemiddelstyrelser.
English: The patients' representative on the Board asked to address in the reflection paper the increasing difficulty of patients' representatives to participate in the Agency's activities due to resource constraints.
Danish: Patienternes repræsentant i bestyrelsen bad om, at man i arbejdsdokumentet inddrog de stedse større problemer, som patienternes repræsentanter havde med at deltage i agenturets aktiviteter på grund af ressourcebegrænsninger.
English: While recognising that the interests of the healthcare professionals (HCP) organisations are more diverse than those of the patients, the Board asked to continue to explore ways on how to best develop interaction with healthcare professionals.
Danish: I erkendelse af at sundhedsmedarbejderorganisationernes interesser er bredere end patientorganisationernes bad bestyrelsen om, at man fortsat undersøgte mulighederne for at udvikle samspillet med sundhedsmedarbejderne på bedste måde.
English: The experience with the revised CV template will be reviewed in the future.
Danish: Erfaringerne med den reviderede cv-model ville blive drøftet senere.
English: The revisions concern the fees for consultation on line-extensions for ancillary substances, including blood derivates, incorporated in medical devices; and the implementation of the new regulation on maximum residue limits.
Danish: Revisionerne vedrørte gebyrer for forlængelser af onlinekonsultationer for hjælpestoffer, herunder blodderivater i medicinske anordninger samt gennemførelsen af den nye forordning om maksimalgrænser for restkoncentrationer.
English: The Board expressed its willingness to meet with Commissioners to discuss the concerns expressed.
Danish: Bestyrelsen var rede til at mødes med medlemmer af Kommissionen for at drøfte spørgsmålet.
English: Feedback form the members is expected in a week's time, following which the proposal will be finalised and re-presented at the October Heads of Medicines Agencies meeting, and later submitted for adoption by the Board in December.
Danish: Feedbackskemaet fra medlemmerne forventedes at indløbe inden for den følgende uge, hvorefter forslaget ville blive fremlagt i endelig form på cheferne for de nationale lægemiddelstyrelsers møde i oktober og fremsendt til godkendelse i bestyrelsen i december.
English: The members noted the update report from the Heads of Medicines Agencies (HMA) on a number of topics, including: the development of the new HMA strategy paper, expected to be completed by the end of 2010; the ongoing discussion on transparency issues, with focus on commercially confidential information; and the reflection on the future of the veterinary medicines legislation.
Danish: Medlemmerne noterede sig den ajourførte rapport fra cheferne for de nationale lægemiddelstyrelser om en lang række emner: Udviklingen af et nyt strategidokument for cheferne for de nationale lægemiddelstyrelser, som forventedes at foreligge inden udgangen af 2010 med fokus på kommercielt fortrolige oplysninger samt overvejelser over fremtiden for lovgivning om veterinærlægemidler.
English: Report on interaction with patients' organisations
Danish: Rapport om samspil med patientorganisationer
English: [EMEA/433259/2009] The Board noted the outcome of the written procedure on consultation on the nomination to the CVMP and considered the nomination as insufficient.
Danish: [EMEA/433259/2009] Bestyrelsen bemærkede sig resultatet af den skriftlige procedure om høringen vedrørende udnævnelsen af et medlem til CVMP og fandt, at udnævnelsen var utilstrækkelig.
English: The findings will be presented to the EMEA Management Board topic coordinators and to the Management Board in December.
Danish: Resultaterne ville blive forelagt bestyrelsens emnekoordinatorer og bestyrelsen selv i december.
English: [EXT/548688/2009] Further to the decision of the Telematics steering committee and the proposal of the European Commission, the Management Board adopted the decision to create the EMEA Management Board Telematics Committee (MBTC) as a subgroup of the Management Board.
Danish: [EXT/548688/2009] I overensstemmelse med telematikstyringsudvalgets beslutning og EuropaKommissionens forslag vedtog bestyrelsen at ændre telematikudvalget (MBTC) til en undergruppe under bestyrelsen.
English: The first discussion on the draft road map at the HMA level is planned for later this year, in time to submit the document for discussion at the EMEA Management Board in December.
Danish: Den første drøftelse af udkastet til køreplan blandt cheferne for de nationale lægemiddelstyrelser forventedes at finde sted senere på året, således at der kunne fremsendes et dokument til diskussion i EMEA's bestyrelse i december.
English: EMEA/MB/642672/2009/EN/Adopted 13 November 2009
Danish: EMA/MB/151652/2010/DA Vedtaget 13. november 2009
English: [EMEA/69619/2009] The Management Board adopted the 2009 part of the telematics master plan.
Danish: [EMEA/69619/2009] Bestyrelsen vedtog 2009-delen af telematikmasterplanen.
English: The Board was invited to send comments with regards to the outlined proposal ahead of its presentation in December.
Danish: Bestyrelsen blev bedt om at fremlægge bemærkninger til forslaget forud for fremlæggelsen i december.
English: [EMEA/MB/366757/2009] The Management Board noted the adoption of the minutes by written procedure on 28 July 2009.
Danish: [EMEA/MB/366757/2009] Bestyrelsen noterede sig vedtagelsen af referatet gennem den skriftlige procedure den 28. juli 2009.
English: [A6-0162_2009_EN] European Parliament decision on discharge to the Executive Director of the EMEA [EMEA/MB/528743/2009] Update report on EMEA implementation of EU telematics strategy.
Danish: [A6-0162_2009_EN] Europa-Parlamentets beslutning om decharge til EMEA's administrerende direktør [EMEA/MB/528743/2009] Ajourført rapport om EMEA's gennemførelse af EU's telematikstrategi [EMEA/472819/2009*, EMEA/MB/569756/2009] Rapporter om gennemførelsen af EudraVigilance for humanmedicinske og veterinærmedicinske lægemidler.
English: [EMEA/MB/517930/2009] Outcome of written procedures: - On consultation on changes in the membership of the CHMP and CVMP scientific committees; - Final accounts 2008; - Minutes of the 64th meeting of the Management Board;
Danish: [EMEA/MB/517930/2009] Resultat af skriftlige procedurer: - Om høring om ændringer i medlemskabet af CHMP- og CVMP-udvalgene - Endeligt regnskab for 2008 - Referat af bestyrelsens 64.
English: Vacancy notice for the Executive Director's function
Danish: Opslag om stillingen som administrerende direktør
English: The Board asked to convene the committee and present its terms of reference at the December meeting.
Danish: Bestyrelsen bad om at få indkaldt udvalget og fremlægge dets kommissorium på mødet i december.
English: Fergus Sweeney Mario Benetti Claus Christiansen Hans-Georg Eichler Anne-Sophie Henry-Eude Xavier Luria Arielle North Nerimantas Steikūnas Spiros Vamvakas
Danish: Fergus Sweeney Mario Benetti Claus Christiansen Hans-Georg Eichler Anne-Sophie Henry-Eude Xavier Luria
English: [EMEA/MB/565964/2009] The Board also noted the proposed future amendment of the fee implementing rules in relation to the new legislation on variations.
Danish: [EMEA/CHMP/565964/2009] Bestyrelsen bemærkede sig også den foreslåede ændring af gebyrgennemførelsesbestemmelserne i relation til den nye lovgivning om ændringer.
English: [EMEA/MB/503751/2009] The Management Board reviewed the progress of the implementation of the Agency's work programme 2009.
Danish: [EMEA/MB/503751/2009] Bestyrelsen drøftede fremskridtet med gennemførelsen af agenturets arbejdsprogram for 2009.
English: [EMEA/MB/575748/2009] The Board noted the mandate and the report on the first year of operation of the Ad Hoc Pharmacovigilance Inspectors Working Group.
Danish: [EMEA/MB/575748/2009] Bestyrelsen noterede sig mandatet og rapporten om det første arbejdsår for ad hoc-arbejdsgruppen for lægemiddelovervågningsinspektører.
English: The Management Board proposed to invite the chair of the HMPC to present the work of the Committee and the challenges it encounters at its December meetings.
Danish: Bestyrelsen foreslog at invitere formanden for Udvalget for Plantelægemidler til møderne i december for at præsentere udvalgets arbejde og de udfordringer, det stod over for.
English: While the Management Board is awaiting a reply from the Commission to its latest correspondence, the Board considers that this issue remains open, and expects that the publication of the vacancy notice will not proceed without the outstanding issue being resolved.
Danish: Bestyrelsen afventede nu Kommissionens svar på sit seneste brev og mente ikke, at sagen endnu var afklaret.
English: [EMEA/MB/517929/2009] The Board adopted the proposals aiming to improve the consultation process on nomination of scientific committee members.
Danish: [EMEA/MB/517929/2009] Bestyrelsen vedtog forslagene til forbedring af høringsprocessen for udnævnelse af videnskabelige udvalgsmedlemmer.
English: [EMEA/MB/589426/2009] The Management Board noted the report on interaction with patients' and consumers' organisations.
Danish: [EMEA/MB/589426/2009] Bestyrelsen noterede sig rapporten om samspillet med patient- og forbrugerorganisationer.
English: [EMEA/MB/320040/2009] Summary of transfers of appropriations in the budget 2009.
Danish: møde - Tillægsbudget 01-2009 [EMEA/MB/320040/2008] Sammendrag af bevillingsoverførsler på budgettet for 2009.
English: Minutes of the sixty-fourth meeting of the Management Board
Danish: Referat af bestyrelsens 64.
English: Management Board members reviewed and provided written comments on the proposed vacancy notice for the Executive Director's post.
Danish: Bestyrelsesmedlemmerne gennemgik forslaget til opslag vedrørende stillingen som administrerende direktør og fremlagde skriftlige bemærkninger dertil.
English: A correction was introduced under point 16 of the minutes (rules on attachment of staff).
Danish: 6 (regler for udstationering af personale).
English: − Thomas Lönngren;
Danish: EMEA udnævnte følgende repræsentanter: Thomas Lönngren;
English: Draft agenda for 1 October 2009 meeting
Danish: møde London, den 1. oktober 2009
English: − 2 members of the EMEA;
Danish: 3 medlemmer fra cheferne for de nationale lægemiddelstyrelser 2 medlemmer fra EMEA
English: Amendments to the fee implementing rules
Danish: Bestyrelsen vedtog revisionerne af gebyrgennemførelsesbestemmelserne.
English: [EMEA/MB/358420/2009] The agenda was adopted.
Danish: Forslag til dagsorden for mødet den 1. oktober 2009 [EMEA/MB/358420/2009] Dagsordenen blev vedtaget.
English: − Marcus Müllner;
Danish: Bestyrelsen udnævnte følgende medlemmer: Marcus Müllner;
English: Minutes from the 63rd meeting, held on 11 June 2009
Danish: møde den 11. juni 2009
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging
Danish: SIKLOS 1000 mg Filmovertrukket tablet
English: --1 Each dose (0.007 ml) of undiluted vaccine contains: - Eimeria acervulina, strain 003 - 332-450 sporulated oocysts - Eimeria maxima, strain 013 - 196 - 265 sporulated oocysts - Eimeria mitis, strain 006 - 293 - 397 sporulated oocysts - Eimeria praecox, strain 007 - 293 - 397 sporulated oocysts - Eimeria tenella, strain 004 - 276-374 sporulated oocysts
Danish: Eimeria acervulina, stamme 003 - 332 - 450 sporulerede oocyster Eimeria maxima, stamme 013- -196 - 265 sporulerede oocyster Eimeria mitis, stamme 006 - 293 - 397 sporulerede oocyster Eimeria praecox, stamme 007 - 293 - 397 sporulerede oocyster Eimeria tenella, stamme 004 - 276 - 374 sporulerede oocyster
English: The recommended starting dose of Pioglitazone Teva is 15 or 30 mg once a day.
Danish: Den anbefalede startdosis af Pioglitazone Teva er 15 eller 30 mg en gang dagligt.
English: The full EPAR for Pioglitazone Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Pioglitazone Teva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pioglitazone Teva on 26 March 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pioglitazone Teva den 26. marts 2012.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pioglitazone Teva.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Pioglitazone Teva skal anvendes.
English: The active substance in Pioglitazone Teva, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Danish: Det aktive stof i Pioglitazone Teva, pioglitazon, gør cellerne (fedt, muskel og lever) mere følsomme over for insulin, hvilket betyder, at kroppen bedre udnytter den insulin, den selv producerer.
English: Treatment with Pioglitazone Teva should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Danish: Behandlingen med Pioglitazone Teva skal tages op til fornyet vurdering efter tre til seks måneder og afbrydes hos patienter, der ikke har tilstrækkelig gavn af behandlingen.
English: This means that Pioglitazone Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Danish: Det betyder, at Pioglitazone Teva er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU), og som hedder Actos.
English: For more information about treatment with Pioglitazone Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pioglitazone Teva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The CHMP concluded that, in accordance with EU requirements, Pioglitazone Teva has been shown to have comparable quality and to be bioequivalent to Actos.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Pioglitazone Teva er af sammenlignelig kvalitet og er bioækvivalent med Actos.
English: Pioglitazone Teva is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Danish: Pioglitazone Teva anvendes til behandling af type 2-diabetes hos voksne (på 18 år og derover), især overvægtige.
English: This is a summary of the European public assessment report (EPAR) for Pioglitazone Teva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pioglitazone Teva.
English: Pioglitazone Teva is a medicine that contains the active substance pioglitazone.
Danish: Pioglitazone Teva er et lægemiddel, der indeholder det aktive stof pioglitazon.
English: Pioglitazone Teva is a ‘generic medicine'.
Danish: Pioglitazone Teva er et ‘generisk lægemiddel'.
English: Other information about Pioglitazone Teva
Danish: Andre oplysninger om Pioglitazone Teva
English: Pioglitazone Teva should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease).
Danish: Pioglitazone Teva bør ikke anvendes til patienter i dialyse (en blodrensningsteknik, der anvendes hos personer med nyresygdom).
English: Because Pioglitazone Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Danish: Da Pioglitazone Teva er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Actos.
English: Because Pioglitazone Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Pioglitazone Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Pioglitazone Teva can also be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Danish: Pioglitazone Teva kan også anvendes sammen med insulin til patienter, som ikke er tilfredsstillende reguleret med insulin alene, og som ikke kan tage metformin.
English: What are the benefits and risks of Pioglitazone Teva?
Danish: Hvilken fordel og risiko er der forbundet med Pioglitazone Teva?
English: Pioglitazone Teva is used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Danish: Pioglitazone Teva anvendes som enebehandling til patienter, hos hvem metformin (et andet lægemiddel mod diabetes) ikke er egnet.
English: The Committee recommended that Pioglitazone Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Pioglitazone Teva.