FrancophonIA/ELRC3.0 huggingface dataset:
English: The move towards developing more targeted and individualised medicines, continuous development and use of state-of-the-art knowledge and technologies in drug development, and integration of development and use of medicines and medical devices all contribute to the increasing complexity of the scientific advice and other Agency's activities.
Danish: Udviklingen hen mod mere målrettede og individualiserede lægemidler, de stadige fremskridt med udnyttelse af den nyeste viden og teknik i lægemiddeludvikling og integreringen af udviklingen og anvendelsen af lægemidler og medicinsk udstyr er alt sammen med til at gøre agenturets videnskabelige rådgivning og øvrige aktiviteter mere komplekse.
English: As a result, increased focus on ensuring that medicines tested and manufactured outside the EU meet the EU requirements will drive efforts to develop and strengthen collaboration with international partners regarding collaborative inspections, information exchange, capacity building and greater mutual reliance.
Danish: Der bliver derfor øget fokus på, at lægemidler, der afprøves og fremstilles uden for EU, opfylder EU-kravene, og dermed øget behov for at udvikle og styrke samarbejdet med internationale partnere om fælles inspektioner, informationsudveksling, kapacitetsopbygning og større gensidig tillid.
English: This will affect the way the scientific committees evaluate medicines, and consequently the workload of the Agency, both in its endeavour to support the scientific assessment of the committees and in its role as a key provider of training, technical and methodological guidance for the scientific work.
Danish: Dette vil påvirke de videnskabelige udvalgs arbejdsmåde ved vurderingen af lægemidler og dermed også agenturets arbejdsbelastning med dels at støtte udvalgenes videnskabelige vurderinger og dels have rollen som hovedleverandør af oplæring og teknisk og metodologisk vejledning til det videnskabelige arbejde.
English: Pharmacovigilance and clinical trials legislation
Danish: Lægemiddelovervågning og lovgivning om kliniske forsøg
English: The revision of the EU veterinary medicines legislation is expected to impact the Agency's activities once the legislation is adopted.
Danish: Dette forventes at få betydning for agenturets aktiviteter, når lovgivningen er vedtaget.
English: As part of this change, the volume of data and information to be managed and the number of procedures to be run will increase significantly over the next years.
Danish: Denne ændring vil i de kommende år medføre en betydelig stigning i den mængde data og oplysninger, der skal håndteres og det antal procedurer, der skal gennemføres.
English: The coming years will see an increasing need to consider aspects such as patients' values and preferences, the needs of other stakeholders (e.g. health-technology assessment bodies, or HTAs) when planning clinical research programmes and post-authorisation measures, the impact of 'real life' evidence data, and others.
Danish: I de kommende år bliver det nødvendigt at lægge øget vægt på aspekter som patienters værdier og præferencer og andre interessenters (f.eks. sundhedsvurderende instanser) behov ved planlægningen af kliniske forskningsprogrammer og foranstaltninger efter godkendelse foruden betydningen af evidens fra det virkelige liv m.m.
English: Veterinary medicines legislation
Danish: Lovgivningen om lægemidler til dyr
English: • Implement pharmacovigilance legislation and the clinical trials legislation.
Danish: • Lovgivningen om lægemiddelovervågning og om kliniske forsøg skal gennemføres.
English: The increasing complexity and globalisation of medicines supply chains will also require improved information exchange and closer, more streamlined cooperation among authorities, to ensure product and data integrity, and continuity of the medicines supply chain.
Danish: Også de stadigt mere komplekse og globaliserede leverandørkæder for lægemidler vil kræve bedre informationsudveksling og tættere, mere strømlinet samarbejde mellem myndighederne for at sikre produkt- og dataintegritet og kontinuitet i leverandørkæden for lægemidler.
English: Growing interdependencies between committees and scientific disciplines in the decision-making further emphasise the need to continuously simplify and align processes, improve quality assurance and quality control, increase robustness of the processes and reach higher efficiency of the evaluation procedures.
Danish: Den voksende gensidige afhængighed mellem udvalgenes beslutningsprocesser og de videnskabelige discipliner stiller endnu større krav om forenklede, ensrettede processer, bedre kvalitetssikring og kvalitetskontrol, mere robuste processer og mere effektive vurderingsprocedurer.
English: This translates into an increasing need for managing and sharing reliable data, in particular to support evidence-based regulatory decision-making grounded on science, improve the use of medicines and satisfy the demands for greater transparency and openness.
Danish: Dette vil give øget behov for behandling og deling af pålidelige data til at støtte den regulatoriske beslutningstagning på videnskabeligt evidensgrundlag, forbedre anvendelsen af lægemidler og imødekomme behovet for øget gennemsigtighed og åbenhed.
English: Therefore, the EMA will continue its collaboration with its EU and international partners on a number of initiatives aimed at limiting the development of AMR.
Danish: Agenturet vil derfor med partnere i og uden for EU fortsætte samarbejdet om en række initiativer til begrænsning af udviklingen af antimikrobiel resistens.
English: Factors such as advances in and growing complexity of medicines development, globalisation, the increasing role of social media as an information source, growing expectation for transparency, key legislation changes and continuous striving for increased efficiency, all impact the Agency's work.
Danish: Agenturets arbejde påvirkes af faktorer såsom lægemiddeludviklingens fremskridt og voksende kompleksitet, globaliseringen, de sociale mediers stigende betydning som informationskilde, øgede forventninger til gennemsigtighed, vigtige lovændringer og vedholdende indsats til effektivisering.
English: The revision of the EU's veterinary medicines legislation, with the aim of significantly simplifying the regulatory requirements, while maintaining a high level of protection of human and animal health, is expected to impact the Agency's activities once the legislation is adopted.
Danish: Med revisionen af EU's lovgivning om lægemidler til dyr tilsigtes en væsentlig forenkling af de regulatoriske krav samtidig med opretholdelse af et højt beskyttelsesniveau for menneskers og dyrs sundhed og miljøet.
English: Efficiency is key to the successful delivery of the Agency's activities and to coping with the growing number of responsibilities and increasing complexity of the regulatory procedures.
Danish: Agenturet skal arbejde effektivt for at kunne varetage sine opgaver og stigende ansvarsområder i stadigt mere komplicerede reguleringsprocedurer.
English: To address these developments, the Agency continues to consolidate and enhance its collaboration with and support to the NCAs through a number of initiatives, including a revised training and competence development programme in cooperation with national authorities, promoting the national experts programme, and prioritising its information technology development programme with projects that support the work, effectiveness and efficiency of the NCAs.
Danish: Dette sker ved initiativer som et revideret kursus- og kompetenceudviklingsprogram i samarbejde med nationale myndigheder, fremme af de nationale ekspertprogrammer og prioritering af agenturets program for informationsteknologisk udvikling med projekter, der støtter de konpetente nationale myndigheders arbejde, gennemslagskraft og effektivitet.
English: This means the environment trends, workload forecasts and implementation of a number of objectives and activities described in this work programme will impact the national authorities and their work as well.
Danish: Derfor vil også disse myndigheders arbejde blive påvirket af udviklingen på miljøområdet, den forventede arbejdsbelastning og gennemførelsen af en række målsætninger og aktiviteter i dette arbejdsprogram.
English: To deliver on its responsibilities, the EMA works closely with the NCAs.
Danish: EMA arbejder tæt sammen med de konpetente nationale myndigheder for at varetage sine opgaver.
English: substance management service
Danish: Viceadministrerende direktør
English: Organization (WHO), thus highlighting AMR as a global health crisis of similar importance to pandemics of an infectious disease.
Danish: Problemets alvor erkendes også med udarbejdelsen af den globale handlingsplan for antimikrobiel resistens i verdenssundhedsorganisationen (WHO), som understreger, at antimikrobiel resistens er en global sundhedskrise af samme betydning som pandemier af smitsomme sygdomme.
English: At the same time, the ability to manage the increasing workload is on occasion limited by the current capacity of the Network, and finding sustainable solutions for maintaining and increasing the Network's capacity will be an important focus area.
Danish: Det bliver derfor et vigtigt fokusområde at opretholde og øge netværkets kapacitet med bæredygtige løsninger.
English: As the EMA enhances its efforts to share knowledge and information with the NCAs, patients, healthcare professionals, media and other stakeholders, the central coordination role of the Agency becomes more important.
Danish: I takt med ECHA's forstærkede indsats til videndeling og information i forhold til de konpetente nationale myndigheder, patienter, sundhedspersoner og andre interessenter ventes efterspørgslen efter data at stige.
English: The increasing use of internet and social media when searching for medicines-related information raises the importance of EMA using these communication channels more widely, to ensure easy, consistent and timely access to authoritative, reliable and understandable information on medicines.
Danish: Dette gør det vigtigere at øge udbredelsen af disse kommunikationsmidler til ubesværet, konsistent og rettidig adgang til autoritativ, pålidelig og forståelig information om lægemidler.
English: The growing need for industry and academia to approach the regulators early in their endeavours increases the role of the Agency in facilitating such contact and ensuring early knowledge sharing.
Danish: Derved får agenturet en øget rolle med at fremme denne kontakt og tidlig videndeling.
English: The ever-increasing role of information technology in health-related matters, including use of e-health records and databases, mobile communications and social media by consumers and healthcare professionals, also demands that surveillance methods evolve to consider these developments.
Danish: Tilsvarende bør overvågningsmetoderne udvikles i takt med, at forbrugere og sundhedspersoner i stigende grad anvender IT i sundhedssammenhæng, herunder elektroniske patientjournaler og databaser, mobilkommunikation og sociale medier.
English: The expected growing need for industry and academia to approach the regulators early in their endeavours will increase the role of the Agency in facilitating such contact and early knowledge sharing.
Danish: Industrien og det videnskabelige samfunds har et voksende behov for på et tidligt tidspunkt i deres bestræbelser at komme i kontakt med de regulerende myndigheder.
English: Subtotal AST Total AST SC 6
Danish: Af den viceadministrerende direktør, Andreas Pott
English: The growing trend for patients and healthcare professionals to use the internet, mobile communications and social media when searching for medicines-related information raises the importance of using these communication channels more widely, to ensure easy, consistent and timely access to authoritative, reliable and understandable information on medicines.
Danish: Patienter og sundhedspersoner benytter i stigende omfang internet, mobilkommunikation og sociale medier, når de søger efter lægemiddelrelaterede oplysninger.
English: The increased demand for access to data and data integration will thus bring new challenges for the Agency.
Danish: Dette vil i forbindelse med bedre dataintegration forstærke agenturets centrale koordinerende rolle.
English: 24 September 2013
Danish: Den 24. september 2013
English: International non-proprietary name (INN): deltamethrin
Danish: Internationalt fællesnavn (INN): deltamethrin
English: Article 33(4) of Directive 2001/82/EC, as amended
Danish: Artikel 33, stk. 4, i direktiv 2001/82/EF, som ændret
English: For the pour-on product 24 concerned Member States are involved: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain.
Danish: For pour-onproduktet er der 24 berørte medlemsstater: Østrig, Belgien, Bulgarien, Cypern, Tjekkiet, Danmark, Estland, Frankrig, Tyskland, Grækenland, Ungarn, Island, Irland, Italien, Letland, Litauen, Luxembourg, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Slovenien og Spanien.
English: The opinion was converted into a Decision by the European Commission on 24 September 2013.
Danish: Udtalelsen blev den 24. september 2013 omarbejdet til en beslutning af Europa-Kommissionen.
English: The reference Member State is the United Kingdom for both products.
Danish: Det Forenede Kongerige er referencemedlemsstat for begge produkter.
English: The Committee appointed Dr C. Ibrahim as rapporteur and Ms H. Jukes as co-rapporteur.
Danish: Som rapportør og medrapportør udpegede udvalget henholdsvis Dr C. Ibrahim og fru H. Jukes.
English: The decentralised procedure started on 19 December 2011.
Danish: Den decentrale procedure blev indledt den 19. december 2011.
English: Potential serious risks were identified during the decentralised procedure by Germany and the Netherlands regarding the environmental safety of the product.
Danish: Under den decentrale procedure påpegede Tyskland og Nederlandene potentielle alvorlige risici vedrørende produktets miljøsikkerhed.
English: Written explanations were provided by the applicant on 22 May
Danish: Ansøgeren indsendte skriftlige redegørelser den 22. maj 2013.
English: For the spot-on product Belgium, France, Germany and the Netherlands are involved as concerned Member States.
Danish: For spot-onproduktet er Belgien, Frankrig, Tyskland og Nederlandene berørte medlemsstater.
English: The referral procedure started on 6 March 2013.
Danish: Henvisningsproceduren blev indledt den 6. marts 2013.
English: Day 60 of the CMD(v) procedure was on 14 February 2013, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Danish: proceduren i CMD(v) var den 14. februar 2013, og da de berørte medlemsstater ikke var i stand til at nå til enighed vedrørende produktet, blev proceduren indbragt for CVMP.
English: These are ‘hybrid' applications according to Art. 13(3) Directive 2001/82/EC, as amended, referring to the reference products Pfizer Pour On Insecticide 1% w/v Cutaneous Solution and Pfizer Spot On Insecticide 1% w/v Cutaneous Solution multidose registered in the United Kingdom.
Danish: Ansøgningerne er hybride ansøgninger i henhold til artikel 13, stk. 3, i direktiv 2001/82/EF, som ændret, og henviser til referenceprodukterne Pfizer Pour On Insecticide 1 % w/v Cutaneous Solution og Pfizer Spot On Insecticide 1% w/v Cutaneous Solution multidose, som er godkendt i Det Forenede Kongerige.
English: On 26 February 2013, the reference Member State, the United Kingdom, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Danish: Den 26. februar 2013 underrettede referencemedlemsstaten, Det Forenede Kongerige, Det Europæiske Lægemiddelagentur om, at CMD(v) ikke havde været i stand til at nå til enighed vedrørende produktet, og indbragte sagen for CVMP i medfør af artikel 33, stk. 4, i direktiv 2001/82/EF.
English: On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures
Danish: På dag 210 var disse spørgsmål fortsat uafklarede, hvorfor sagen den 17. december 2012 i henhold til artikel 33, stk. 1, i direktiv 2001/82/EF blev indbragt for koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede godkendelsesprocedurer - veterinær (CMD(v)).
English: Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle contain deltamethrin as active ingredient and is intended for use in cattle and sheep as a topical application for the treatment and prevention of infestations by lice and flies on cattle; ticks, lice, keds and established blowfly strike on sheep and lice and ticks on lambs.
Danish: Deltanil, pour-on, opløsning, 10 mg/ml, til kvæg og får samt Deltanil, spot-on, opløsning, 100 mg, til kvæg indeholder deltamethrin som aktivt stof og er bestemt til topikal anvendelse hos kvæg og får til behandling og forebyggelse af luse- og flueangreb på kvæg, af flåter, lus, fårelus og etablerede spyflue-angreb på får samt af lus og flåter på lam.
English: Therefore, the Committee adopted by majority a positive opinion on 17 July 2013 recommending the granting of the marketing authorisations for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle.
Danish: Udvalget vedtog derfor ved en flertalsafgørelse den 17. juli 2013 en positiv udtalelse, der anbefaler udstedelse af markedsføringstilladelse for Deltanil, pour-on, opløsning, 10 mg/ml, til kvæg og får samt Deltanil, spot-on, opløsning, 100 mg, til kvæg.
English: Opinion following an Article 33(4)0F referral for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle EMA/539462/2013
Danish: Udtalelse efter en artikel 33, stk. 40F-indbringelse for Deltanil, pour-on, opløsning, 10 mg/ml, til kvæg og får, samt Deltanil, spot-on, opløsning, 100 mg, til kvæg EMA/620974/2013
English: The applicant, Virbac, submitted an application for a decentralised procedure for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle.
Danish: Ansøgeren, Virbac, indgav en ansøgning efter den decentrale procedure for Deltanil, pour-on, opløsning, 10 mg/ml, til kvæg og får samt Deltanil, spot-on, opløsning, 100 mg, til kvæg.
English: Opinion following an Article 33(4)1 referral for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle
Danish: Udtalelse efter en artikel 33, stk. 41-indbringelse for Deltanil, pour-on, opløsning, 10 mg/ml, til kvæg og får, samt Deltanil, spot-on, opløsning, 100 mg, til kvæg
English: Based on the evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle is positive.
Danish: Efter vurdering af de foreliggende data fandt CVMP, at benefit/risk-forholdet er positivt for Deltanil, pour-on, opløsning, 10 mg/ml, til kvæg og får, og Deltanil, spot-on, opløsning, 100 mg, til kvæg.
English: 10 November 2011
Danish: Den 10. november 2011
English: 1 Article 78 of Directive 2001/82/EC
Danish: 1 Artikel 78 i direktiv 2001/82/EF
English: Opinion following an Article 78
Danish: Udtalelse efter en artikel 78
English: The final opinion was converted into a Decision by the European Commission on 3 November 2011.
Danish: Den endelige udtalelse blev den 3. november 2011 omarbejdet til en beslutning af EuropaKommissionen.
English: The procedure started on 5 May 2011.
Danish: Proceduren blev indledt den 5. maj 2011.
English: The rapporteur and co-rapporteur appointed were Dr JeanClaude Rouby and Dr David Murphy, respectively.
Danish: Som rapportør og medrapportør udpegedes henholdsvis dr. Jean-Claude Rouby og dr. David Murphy.
English: procedure for
Danish: 1-procedure vedrørende
English: A written explanation was provided by the representative of the marketing authorisation holder on 23 May 2011.
Danish: En skriftlig redegørelse blev fremlagt af indehaveren af markedsføringstilladelsen den 23. maj 2011.
English: HIPRABOVIS PNEUMOS Emulsion for injection for cattle and associated names
Danish: HIPRABOVIS PNEUMOS, injektionsvæske, emulsion, til kvæg, og tilknyttede navne
English: Due to concerns regarding reports of anaphylactic-type events following use of HIPRABOVIS PNEUMOS Emulsion for injection for cattle, France suspended the marketing authorisation for the product on 6 April 2011 triggering a procedure under Article 78 of Directive 2001/82/EC.
Danish: På grund af betænkelighed vedrørende indberetninger om hændelser af anafylaktisk art efter anvendelse af HIPRABOVIS PNEUMOS, injektionsvæske, emulsion, til kvæg, suspenderede Frankrig markedsføringstilladelsen for produktet den 6. april 2011 og indledte dermed en procedure i henhold til artikel 78 i direktiv 2001/82/EF.
English: HIPRABOVIS PNEUMOS Emulsion for injection for cattle is an inactivated vaccine for reduction of the clinical signs and lung lesions caused by Mannheimia haemolytica serotype A1 and Histophilus somni in calves from 2 months of age.
Danish: HIPRABOVIS PNEUMOS, injektionsvæske, emulsion, til kvæg, er en inaktiveret vaccine til reduktion af kliniske tegn og lungeforandringer forårsaget af Mannheimia haemolytica serotype A1 og Histophilus somni hos kalve fra 2-måneders alderen.
English: Based on the rapporteurs' assessment of the data available from pharmacovigilance reports and a laboratory study, the CVMP concluded that the underlying cause of the adverse events observed has yet to be determined; the data evaluated indicated an association between vaccination of cattle with HIPRABOVIS PNEUMOS Emulsion for injection for cattle and the occurrence of anaphylactic-type events; no corrective measures could be recommended; and the benefit-risk balance for the product was unfavourable.
Danish: På grundlag af rapportørernes vurdering af de foreliggende data fra lægemiddelovervågningsrapporter og en laboratorieundersøgelse konkluderede CVMP, at den underliggende årsag til de iagttagne bivirkninger endnu ikke er klarlagt, at de evaluerede data tyder på en sammenhæng mellem vaccination af kvæg med HIPRABOVIS PNEUMOS, injektionsvæske, emulsion, til kvæg, og optræden af hændelser af anafylaktisk art, at der ikke kunne anbefales afhjælpende foranstaltninger, og at benefit/risk-forholdet for produktet er ugunstigt.
English: The Committee, adopted on 14 July 2011, an opinion recommending the suspension of the marketing authorisations for HIPRABOVIS PNEUMOS Emulsion for injection for cattle and associated names until the marketing authorisation holder proposes appropriate measures to mitigate the risk of occurrence of such adverse events and demonstrates a favourable benefit-risk balance for the product when used according to the recommendations of the summary of product characteristics The list of product names concerned is given in Annex I. The scientific conclusions and grounds for suspension of the marketing authorisations are provided in Annex II.
Danish: Udvalget vedtog den 14. juli 2011 en udtalelse, der anbefaler suspendering af markedsføringstilladelserne for HIPRABOVIS PNEUMOS, injektionsvæske, emulsion, til kvæg, og tilknyttede navne, indtil indehaveren af markedsføringstilladelsen foreslår passende foranstaltninger til afbødning af risikoen for sådanne bivirkninger og godtgør, at benefit/risk-forholdet for produktet er gunstigt, når det anvendes i henhold til anbefalingerne i produktresuméet.
English: The text was valid at that time.
Danish: Teksterne var gyldige på det tidspunkt.
English: The following additional safety results were observed in the study:
Danish: Følgende yderligere sikkerhedsresultater blev observeret i undersøgelsen:
English: Less than 2% was recovered as unchanged drug.
Danish: Mindre end 2% blev genfundet som uforandret lægemiddel.