natgillin/translations-raw huggingface dataset:
Du skal underrette Sundhedsstyrelsen og Komitésystemet, hvis der opstår ny viden, der har betydning for forsøgspersonernes sikkerhed, mens forsøget gennemføres.
The Danish Health and Medicines Authority and the Scientific Ethical Committee System must be informed if new knowledge of importance to the safety of trial subjects emerges while the trial is conducted.
Sundhedsstyrelsen vurderer, at fordelene ved vaccinerne fortsat opvejer de mulige risici.
The Danish Health and Medicines Authority assesses that the benefits of the vaccines still outweigh the possible risks.
Styrelsen kan forbyde forhandling og udlevering af et lægemiddel og påbyde, at det trækkes tilbage fra markedet, hvis virksomheden ikke er i besiddelse af en gældende § 39-tilladelse.
The Danish Health and Medicines Authority can prohibit any distribution and dispensing of a medicinal product and order that a product be withdrawn from the market if the company does not hold a valid section 39 authorisation.
På baggrund af data i studiet vurderer Sundhedsstyrelsen, at der ikke på nuværende tidspunkt er anledning til at ændre anbefalingerne for brug af smertestillende medicin under graviditeten.
The Danish Health and Medicines Authority does not find that the research data call for an immediate change of the recommendations for use of painkillers during pregnancy.
Lægemiddelstyrelsen har ingen planer om at udarbejde en dansk version.
The Danish Health and Medicines Authority does not plan to prepare a Danish version.
Sundhedsstyrelsen opfordrer til at anvende denne mulighed.
The Danish Health and Medicines Authority encourages applicants to make use of this opportunity.
Sundhedsstyrelsen forventer, at der bliver inkluderet 16.882 danske forsøgspersoner i de 294 forsøg som er ansøgt i 2013.
The Danish Health and Medicines Authority estimates that 16,882 Danish trial subjects will participate in the 294 trials that were applied for in 2013.
Sundhedsstyrelsen forventer at arbejdet er afsluttet i september 2014.
The Danish Health and Medicines Authority expects that this work is completed in September 2014.
Lægemiddelstyrelsen følger Kommissionens ”Guidance concerning the Braille requirements for labelling and the package leaflet”.
The Danish Health and Medicines Authority follows the Commission's “Guidance concerning the Braille requirements for labelling and the package leaflet”.
Lægemiddelstyrelsen følger Kommissionens ”Guidance concerning the Braille requirements for labelling and the package leaflet”.
The Danish Health and Medicines Authority follows the Commission’s “Guidance concerning the Braille requirements for labelling and the package leaflet”.
Sundhedsstyrelsen har bedt virksomheden tilbagekalde medicinen (batchen).
The Danish Health and Medicines Authority has asked the company to recall the medicine (the batch).
Vi har i Sundhedsstyrelsen efterfølgende besluttet, at vi selv varetager udsendelse af DHPC.
The Danish Health and Medicines Authority has decided that we will send out the DHPCs.
Sundhedsstyrelsen har overholdt de fastsatte sagsbehandlingstider med 98%, og 10% har været behandlet gennem den fælles europæiske procedure VHP.
The Danish Health and Medicines Authority has met 98% of the fixed assessment times, and 10% have been reviewed through the common European Voluntary Harmonisation Procedure (VHP).
Sundhedsstyrelsen har deltaget i forhandlingerne om forslaget og deltager nu i europæiske og nationale arbejdsgrupper for at forberede ikrafttrædelse af forordningen.
The Danish Health and Medicines Authority has participated in the negotiations on the proposal and is now represented in European and national working groups to prepare the coming into force of the regulation.
Sundhedsstyrelsen har udarbejdet en midtvejsstatus for aktiviteter i handlingsplanen for regionernes brug af lægemidler til igangsætning af fødsler.
The Danish Health and Medicines Authority has prepared a midterm review of the activities in the action plan for Danish regions' use of medicines for the induction of labour.
Sundhedsstyrelsen har udarbejdet ny status for Pradaxa® (dabigatran etexilat) og Xarelto® (rivaroxaban), side 5
The Danish Health and Medicines Authority has prepared a new status report for Pradaxa® (dabigatran etexilate) and Xarelto® (rivaroxaban) (p 5)
Sundhedsstyrelsen har tidligere informeret om EU-gennemgangen: EU's bivirkningskomité bekræfter fordelene ved alle typer p-piller
The Danish Health and Medicines Authority has previously informed about the PRAC review: PRAC confirms the benefits of all combined hormonal contraceptives (in Danish)
Sundhedsstyrelsen fastholder anbefaling om influenzavaccination, side 5
The Danish Health and Medicines Authority maintains influenza vaccine recommendation (p 5)
Lægemiddelstyrelsen kan hjælpe med at svare på spørgsmål til enkelte dele af ansøgningen samt procedurespørgsmål, men vi kan ikke evaluere hele dossieret inden ansøgning.
The Danish Health and Medicines Authority may assist by answering questions about some parts of the application as well as procedural questions; however, we cannot evaluate the entire dossier until the application is submitted.
Sundhedsstyrelsen har jævnlige koordinationsmøder med: Sekretariaterne for den nationale og de regionale etiske kommitter, De lægevidenskabelige Selskaber og Lægeforeningen, GCP enhederne, Lægemiddelindustriens udvalg for klinisk udvikling og Genterapi udvalget (miljøstyrelsen, arbejdstilsynet og sundhedsstyrelsen).
The Danish Health and Medicines Authority meets regularly with: The secretariats of the national and regional ethics committees, the Organization of Danish Medical Societies and the Danish Medical Association, the GCP units, the pharmaceutical industry's committee for clinical research and gene therapy committee (Danish Environmental Protection Agency, Danish Working Environment Authority and the Danish Health and Medicines Authority).
Sundhedsstyrelsen har overholdt de fastsatte sagsbehandlingstider med 88 %, og 25 % af ansøgningerne har været behandlet gennem den fælles europæiske procedure VHP.
The Danish Health and Medicines Authority met 88% of the fixed assessment times, and 25% of the applications were reviewed through the common European Voluntary Harmonisation Procedure (VHP).
Sundhedsstyrelsen overvåger og kontrollerer produktfejl på lægemidler på det danske marked for at beskytte mennesker og dyrs sundhed.
The Danish Health and Medicines Authority monitors and checks product defects of medicines on the Danish market to safeguard people as well as animals.
Sundhedsstyrelsen deltager nu i europæiske og nationale arbejdsgrupper for at forberede ikrafttrædelse af forordningen.
The Danish Health and Medicines Authority now participates in European and national working groups to prepare the coming into force of the regulation.
Sundhedsstyrelsen har deltaget i forhandlinger i rådsregi om det af EU Kommissionen fremsatte forslag til nye europæisk lovgivning om kliniske forsøg med lægemidler, som er blevet vedtaget i foråret 2014.
The Danish Health and Medicines Authority participated in the negotiations in the Council for the European Commission's proposal for new European legislation on clinical trials of medicinal products, which was adopted in the spring of 2014.
Sundhedsstyrelsen deltager i forhandlingerne om dette forslag i rådsregi.
The Danish Health and Medicines Authority participates in the negotiations for this proposal in the Council.
Sundhedsstyrelsen modtog 306 ansøgninger og afgjorde 294. 291 forsøg fik en tilladelse i 2013.
The Danish Health and Medicines Authority received 306 applications and reviewed 294. 291 trials were authorised in 2013.
Sundhedsstyrelsen foretager en grundig behandling af alle indberetninger, og vurderer i samarbejde med markedsføringsindehaveren, eller dennes repræsentant, hvorvidt produktfejlen kan føre til en tilbagekaldelse.
The Danish Health and Medicines Authority thoroughly evaluates all reports and assesses in cooperation with the marketing authorisation holder or representative whether the product defect could lead to a withdrawal.
Sundhedsstyrelsen advarer mod at anvende slankemidlerne 'Slimex 15' og 'Slimex 15 new Formula, som sælges på internettet.
The Danish Health and Medicines Authority warns against taking the weight-loss products Slimex 15 and Slimex 15 New Formula that are sold on the internet.
Sundhedsstyrelsens analyse af melatonin-brugere under 25 år
The Danish Health and Medicines Authority's analysis of melatonin users under the age of 25
Sundhedsstyrelsens årsrapport for overvågning af bivirkninger 2012, side 10
The Danish Health and Medicines Authority's annual pharmacovigilance report 2012 (p 10)
Sundhedsstyrelsens rapport om NSAID'er - en undersøgelse af antal brugere, indberettede formodede bivirkninger og utilsigtede hændelser
The Danish Health and Medicines Authority's report on NSAIDs – a study of the number of users, reported suspected adverse reactions and inadvertent incidents
Sundhedsstyrelsen, SKAT og politiet har deltaget i den netop overståede Operation PANGEA VIII - en verdensomspændende aktion med fokus på at bekæmpe ulovligt salg af medicin på internettet og gøre forbrugerne opmærksomme på de risici, som findes ved køb af medicin på nettet.
The Danish Health and Medicines Authority, the Danish customs and tax authorities (SKAT) and the Danish Police participated in the recent Operation PANGEA VIII - a global operation combating illegal online sale of medicines and making consumers aware of the risks associated with buying medicines online.
Fra Danmark deltog Sundhedsstyrelsen, SKAT, politiet og Fødevarestyrelsen i aktionen, med assistance fra Lægemiddelindustriforeningen og Dansk Brand- og Sikringsteknisk Institut.
The Danish Health and Medicines Authority, the Danish customs and tax authorities (SKAT), the Danish Police and the Danish Veterinary and Food Administration participated in the operation and were assisted by the Danish Association of the Pharmaceutical Industry and the Danish Institute of Fire and Security Technology.
Sundhedsstyrelsen: Information om livmoderhalskræft og HPV-vaccination
The Danish Health and Medicines Authority: Information about cervical cancer and HPV vaccination
Sundhedsstyrelsen forventer, at der bliver inkluderet 16.882 danske forsøgspersoner i de 294 forsøg som er ansøgt i 2013.
The Danish Health Authority estimates that 16,882 Danish trial subjects will participate in the 294 trials that were applied for in 2013.
Fra Sundhedsstyrelsen gives følgende anbefalinger:
The Danish Health Authority gives the following recommendations:
Sundhedsstyrelsen har overholdt de fastsatte sagsbehandlingstider med 98 %, og 10 % har været behandlet gennem den fælles europæiske procedure VHP.
The Danish Health Authority has met 98% of the fixed assessment times, and 10% have been reviewed through the common European Voluntary Harmonisation Procedure (VHP).
Sundhedsstyrelsen har udarbejdet årsrapport for 2013 om kliniske forsøg med lægemidler på mennesker.
The Danish Health Authority has published its annual report 2013 on clinical trials of medicines in humans.
Sundhedsstyrelsen har bibeholdt fokus på ulovlige produkter og forfalskninger i 2012.
The Danish Health Authority maintained focus on illegal products and counterfeits in 2012.
Sundhedsstyrelsen har overholdt de fastsatte sagsbehandlingstider med 88 %, og 25 % af ansøgningerne har været behandlet gennem den fælles europæiske procedure VHP.
The Danish Health Authority met 88% of the fixed assessment times, and 25% of the applications were reviewed through the common European Voluntary Harmonisation Procedure (VHP).
Sundhedsstyrelsen modtog i 2013 det højeste antal bivirkninger nogensinde.
The Danish Health Authority received the highest number of adverse reactions ever in 2013
Sundhedsstyrelsen anbefaler, at alle piger bliver vaccineret mod HPV i 12-års alderen.
The Danish Health Authority recommends that all girls are vaccinated against HPV at the age of 12.
Det er Sundhedsstyrelsen, der anbefaler Sundheds- og ældreministeren, hvilke sygdomme børn bør vaccineres imod.
The Danish Health Authority recommends the diseases children should be vaccinated against to the Danish Minister for Health.
Sundhedsstyrelsen vurderer fortsat, at fordelene ved at blive vaccineret langt opvejer de mulige skadevirkninger ved vaccinen.
The Danish Health Authority still estimates that the benefits of vaccination by far outweigh any possible adverse reactions from the vaccine.
Sundhedsstyrelsens anbefalinger for brug af ciprofloxacin og andre fluorokinoloner
The Danish Health Authority's recommendations for use of ciprofloxacin and other fluoroquinolones
Dansk Hypertensionsselskab anfører, at tilskuddet til en række nyttige kombinationspræparater fjernes med mulig forringelse af patient compliance til følge.
The Danish Hypertension Society states that the reimbursement for a number of useful combination products will be removed, resulting in a possible deterioration of patient compliance.
Danmark udgør et lille marked for medicin i global sammenhæng.
The Danish market for medicines is small seen in a global perspective.
Den danske medicintilskudsordning indebærer ikke nogen form for diskrimination til skade for varer, der importeres fra andre medlemsstater, og bevirker ikke, at afsætningen af importerede varer bliver urentabel, umulig eller mere vanskelig end afsætningen af indenlandske varer ligesom den heller ikke bevirker, at bestemte importmønstre umuliggøres eller bliver mere bekostelige end andre.
The Danish medicinal reimbursement system entails no type of harmful discrimination to goods imported from other member states and does not entail that the sale of imported goods becomes unprofitable, impossible or more difficult than the sale of domestic goods, and nor does it entail that certain import patterns are made impossible or become more costly than others.
Endvidere omfatter lægemiddelloven svangerskabsforebyggende midler.
The Danish Medicines Act also regulates contraceptives.
Lægemiddelloven trådte i kraft den 17. december 2005, og en markedsføringstilladelse vil således tidligst kunne bortfalde i henhold til "sunset clause" den 17. december 2008.
The Danish Medicines Act entered into force on 17 December 2005, and hence the earliest date when a marketing authorisation can cease to be valid under the "sunset clause" is 17 December 2008.
Lægemiddelloven nr. 506 af 20. april 2013.
The Danish Medicines Act no. 506 of 20 April 2013 (in Danish only).
Lægemiddelloven danner den lovmæssige ramme om lægemiddelvirksomheders indberetnings- og informationspligt, når de knytter sundhedspersoner til virksomheden.
The Danish Medicines Act provides the legal framework for pharmaceutical companies’ reporting obligation and duty to inform when they establish a relationship with a healthcare professional.
Lægemiddellovens regler om "sunset clause" omfatter alle lægemidler, for hvilke Lægemiddelstyrelsen har udstedt en markedsføringsgodkendelse.
The Danish Medicines Act's rules on the "sunset clause" apply to all medicinal products for which the Danish Health and Medicines Authority has issued a marketing authorisation.
Lægemiddelstyrelsen har i marts og april 2017 modtaget to uafhængige henvendelser fra yngre mænd om formodede bivirkninger i forbindelse med brug af det bredspektrede antibiotikum ciprofloxacin.
The Danish Medicines Agency (DKMA) has in March and April 2017 received two independent reports from younger men about suspected adverse reactions in connection with the use of the broad-spectrum antibiotic ciprofloxacin.
Lægemiddelstyrelsen accepterer, at lægemiddelfremstillere køber sig til auditrapporter.
The Danish Medicines Agency accepts that pharmaceutical manufacturers acquires audit reports.
Lægemiddelstyrelsen vil kunne acceptere, at dato, der anføres under pkt. 6 i indlægssedlen, er dato for afslutningsdagen af den regulatoriske proces.
The Danish Medicines Agency accepts that the date stated under section 6 of the package leaflet is the end date of the regulatory process.
Lægemiddelstyrelsen anerkender, at det kan være en byrde for såvel læge som patient at skifte behandling.
The Danish Medicines Agency acknowledges that switching to another treatment may be a burden to both the general practitioner and the patient.
Lægemiddelstyrelsen fungerer som sekretariat for nævnet.
The Danish Medicines Agency acts as secretariat to the Committee.
Lægemiddelstyrelsen indtaster resultatet af inspektionen i den europæiske database for kliniske forsøg, EudraCT.
The Danish Medicines Agency adds the inspection findings to the European Clinical Trials Database, EudraCT.
Lægemiddelstyrelsen administrerer lovgivningen på området og har derfor myndighedsansvaret for at overvåge sikkerheden af medicinsk udstyr i hele dets livscyklus - fra det først afprøves i sundhedsvæsenet, og til det tages af markedet.
The Danish Medicines Agency administers legislation in this area and is responsible for monitoring the safety of medical devices throughout its life cycle - from the first test in the health service and until it is taken off the market.
Lægemiddelstyrelsen opfordrer personer, der har brugt Melanotan, til at stoppe med at tage det og eventuelt kontakte deres læge.
The Danish Medicines Agency advises patients who have taken Melanotan to stop using it and to contact their doctor if they have any concerns.
Lægemiddelstyrelsen opfordrer personer, der har indtaget Power 1 Walnut til at kontakte deres læge, uanset at de ikke har bemærket bivirkninger i forbindelse med indtagelse af produktet.
The Danish Medicines Agency advises persons who have taken Power 1 Walnut to contact their own doctor regardless of whether or not they have experienced any adverse reactions from the product.
Lægemiddelstyrelsen er enig i, at kombinationslægemidler kan understøtte god compliance i lægemiddelanvendelsen.
The Danish Medicines Agency agrees that combination products may support good compliance in the use of medicinal products.
Lægemiddelstyrelsen er enig med Medicintilskudsnævnet i, at kombinationslægemidler kan understøtte god compliance i lægemiddelanvendelsen, men Lægemiddelstyrelsen finder dog ikke, at dette forhold alene kan retfærdiggøre en pris, der væsentligt overstiger prisen for en kombination af en billigere ACE-hæmmer og amlodipin hver for sig.
The Danish Medicines Agency agrees with the Reimbursement Committee that combination products may support good compliance in the use of medicinal products, but the Danish Medicines Agency does not, however, find that this circumstance in itself can justify a price that significantly exceeds the price of a combination of a less expensive ACE inhibitor and amlodipine separately.
Lægemiddelstyrelsen er enig med Medicintilskudsnævnet i, at kombinationslægemidler kan understøtte god compliance i lægemiddelanvendelsen, men Lægemiddelstyrelsen finder dog ikke, at dette forhold alene kan retfærdiggøre en pris, der væsentligt overstiger prisen for en kombination af en billigere ACE-hæmmer og amlodipin indtaget hver for sig.
The Danish Medicines Agency agrees with the Reimbursement Committee that combination products may support good compliance in the use of medicinal products, but the Danish Medicines Agency does not, however, find that this circumstance in itself can justify a price that significantly exceeds the price of a combination of a less expensive ACE inhibitor and amlodipine separately.
Lægemiddelstyrelsen er enig med Medicintilskudsnævnet i, at kombinationslægemidler kan understøtte god compliance i lægemiddelanvendelsen, men Lægemiddelstyrelsen finder dog ikke, at dette forhold alene kan retfærdiggøre en pris, der væsentligt overstiger prisen for en kombination af en billigere ACE-hæmmer og indapamid hver for sig.
The Danish Medicines Agency agrees with the Reimbursement Committee that combination products may support good compliance in the use of medicinal products, but the Danish Medicines Agency does not, however, find that this circumstance in itself can justify a price that significantly exceeds the price of a combination of a less expensive ACE inhibitor and indapamide separately.
Lægemiddelstyrelsen er enig med Medicintilskudsnævnet i, at kombinationslægemidler kan understøtte god compliance i lægemiddelanvendelsen, men Lægemiddelstyrelsen finder dog ikke, at dette forhold alene kan retfærdiggøre en pris, der væsentligt overstiger prisen på de kombinationslægemidler og enkeltstoflægemidler, som kan erstatte de pågældende kombinationslægemidler med indhold af angiotensin-II antagonister.
The Danish Medicines Agency agrees with the Reimbursement Committee that combination products may support good compliance in the use of medicinal products, but the Danish Medicines Agency does not, however, find that this circumstance in itself can justify a price that significantly exceeds the price of the combination products and individual substances which can replace the combination products in question containing angiotensin II antagonists.
Lægemiddelstyrelsen er enig med Medicintilskudsnævnet i, at kombinationslægemidler kan understøtte god compliance i lægemiddelanvendelsen, men vi finder dog ikke, at den høje pris for kombinationen af metoprolol og felodipin kan retfærdiggøres.
The Danish Medicines Agency agrees with the Reimbursement Committee that combination products may support good compliance in the use of medicinal products, but we do not, however, find that the high price of the combination of metoprolol and felodipine can be justified.
Lægemiddelstyrelsen er enig med Medicintilskudsnævnet i, at kombinationslægemidler kan understøtte god compliance i lægemiddelanvendelsen, men vi finder dog ikke, at den høje pris for kombinationen af verapamil og trandolapril kan retfærdiggøres.
The Danish Medicines Agency agrees with the Reimbursement Committee that combination products may support good compliance in the use of medicinal products, but we do not, however, find that the high price of the combination of verapamil and trandolapril can be justified.
Lægemiddelstyrelsen er enig med Medicintilskudsnævnet i, at kombinationslægemidler kan understøtte god compliance i lægemiddelanvendelsen.
The Danish Medicines Agency agrees with the Reimbursement Committee that combination products may support good compliance in the use of medicinal products.
Lægemiddelstyrelsen er enig med Medicintilskudsnævnets lægefaglige vurdering af lægemidlerne og deres anvendelse.
The Danish Medicines Agency agrees with the Reimbursement Committee's medical assessment of the medicinal products and their use.
Målet er at give en begrundet indsigelse eller en tilladelse inden 30 arbejdsdage.
The Danish Medicines Agency aims to give grounds for non-acceptance or grant authorisation within 30 working days.
Lægemiddelstyrelsen vurderer også produktets dårlige sider, fx bivirkninger og interaktioner.
The Danish Medicines Agency also assesses the product's negative qualities, for example side effects and drug interactions.
Lægemiddelstyrelsen har også gebyrindtægter fra andre områder - herunder fra medicoindustrien for sager om medicinsk udstyr.
The Danish Medicines Agency also generates income from other areas - including from the medical device industry related to medical device cases.
Lægemiddelstyrelsen har også gebyrindtægter fra andre områder - herunder fra medicoindustrien for sager om medicinsk udstyr.
The Danish Medicines Agency also generates income from other areas – including from the medical device industry related to medical device cases.
Lægemiddelstyrelsen offentliggør også en liste over, hvilke virksomheder, der er omfattet af forsøgsordningen og dermed af reglerne om tilknytning.
The Danish Medicines Agency also publishes a list of companies comprised by the pilot programme and thus the rules on relationships.
Lægemiddelstyrelsen modtager også et stigende antal klager direkte fra patienter og sundhedsprofessionelle.
The Danish Medicines Agency also receives an increasing number of complaints directly from patients and healthcare professionals.
Vi modtager også meddelelser om produktfejl ved lægemidler fra udenlandske lægemiddelmyndigheder via det såkaldte ”Rapid Alert System”.
The Danish Medicines Agency also receives notifications about medicinal product defects from other national competent authorities via the 'Rapid Alert System'.