FrancophonIA/ELRC3.0 huggingface dataset:
English: You can search for a medicine by entering its name under ‘search for medicines' on the website's homepage or in the ‘Find medicine' section, by:
Danish: Du kan søge efter et lægemiddel ved at indtaste lægemidlets navn under "Søg efter lægemiddel" ("Search for medicines") på webstedets startside eller under afsnittet "Find medicine”:
English: The European Patent Office may be able to provide information on a specific patent.
Danish: Det Europæiske Patentkontor vil eventuelt kunne give oplysninger om et specifikt patent.
English: The Agency has no control over these decisions.
Danish: Agenturet har ingen indflydelse på disse beslutninger.
English: The Agency has a role in preparing scientific opinions on the quality, safety and efficacy of herbal medicines, to help harmonise this information across the EU.
Danish: Agenturets rolle er at udarbejde videnskabelige udtalelser om plantelægemidlers kvalitet, sikkerhed og virkning for at medvirke til at harmonisere disse oplysninger i hele EU.
English: If you wish to use an acronym for the Agency, use 'EMA'.
Danish: Hvis du vil bruge et akronym for agenturet, skal det være "EMA".
English: Decisions on pricing and reimbursement are made at a national level following negotiations between governments and marketing authorisation holders.
Danish: Beslutninger om prisfastsættelse og tilskud træffes på nationalt plan efter forhandlinger mellem de respektive regeringer og indehaverne af markedsføringstilladelser.
English: What does the Agency not control?
Danish: Hvad kontrollerer agenturet ikke?
English: During the evaluation procedure, the Agency publishes information relevant to the evaluation timetable in the agenda and minutes of the meetings of its relevant scientific committees.
Danish: Under vurderingsproceduren offentliggør agenturet oplysninger, der er relevante i henhold til tidsplanen, i dagsordenen for og referatet af de videnskabelige udvalgs møder.
English: • searching by keyword;
Danish: • ved at bruge søgefunktionen med nøgleord (keyword)
English: Following a positive recommendation from the Agency, the European Commission takes around two months to approve a medicine.
Danish: Efter en positiv anbefaling fra agenturet tager det omkring to måneder for Europa-Kommissionen at godkende lægemidlet.
English: My medicine has been evaluated by the Agency but is not available in my country.
Danish: Mit lægemiddel er blevet vurderet af agenturet, men fås ikke i mit hjemland.
English: They are not evaluated by the Agency.
Danish: De vurderes ikke af agenturet.
English: You may not be able to obtain a complete list of available treatment options for a specific condition by searching on the Agency's website.
Danish: Det er ikke sikkert, at du kan få en fuld liste over tilgængelige behandlingsmuligheder for en specifik tilstand ved at søge på agenturets websted.
English: No, the Agency is unable to recommend academic courses in regulatory affairs, medicine or any other discipline.
Danish: Nej, agenturet kan ikke anbefale faglige kurser inden for reguleringsspørgsmål, medicin eller andet.
English: The Agency is also unable to give any financial assistance to patients who are trying to get hold of a medicine.
Danish: Agenturet er heller ikke i stand til at yde økonomisk støtte til patienter, som forsøger at få fat på et lægemiddel.
English: Can the Agency recommend academic courses?
Danish: Kan agenturet anbefale faglige kurser?
English: Currently, most of the information on the Agency's website is only available in English.
Danish: I øjeblikket findes de fleste af oplysningerne på agenturets websted kun på engelsk.
English: The Agency also supervises the safety of medicines in the EU after they have been authorised.
Danish: Agenturet overvåger endvidere sikkerheden af lægemidler i EU, efter at de er blevet godkendt.
English: The Agency publishes the names of the actives substance of medicines currently under evaluation but cannot say when the medicines will be approved.
Danish: Agenturet offentliggør navnene på de aktive stoffer i lægemidler, der er ved at blive vurderet, men kan ikke sige, hvornår lægemidlerne vil blive godkendt.
English: • browsing by therapeutic area or type of medicine.
Danish: • ved at gå til behandlingsområde (therapeutic area) eller lægemiddeltype (type of medicine).
English: To help us direct your query to the right people within the Agency, please indicate whether you are making your enquiry for personal reasons (e.g. a patient or carer, a student, a researcher, a healthcare professional, etc.) or on behalf of an organisation.
Danish: For at hjælpe os med at lede din forespørgsel frem til de rette personer inden for agenturet bedes du angive, om du spørger af personlige årsager (f.eks. som patient eller omsorgsgiver, studerende, forsker, sundhedsmedarbejder osv.) eller på vegne af en organisation.
English: Questions about the evaluation of other substances
Danish: Spørgsmål om vurderingen af andre stoffer
English: How can I search for a medicine on the Agency's website?
Danish: Hvordan kan jeg søge efter et lægemiddel på agenturets websted?
English: No, EMA does not directly fund research.
Danish: Nej, agenturet yder ikke direkte finansiel støtte til forskning.
English: However, the Agency can be consulted on medical devices that contain medicinal substances.
Danish: Agenturet kan dog blive hørt om medicinsk udstyr, der indeholder lægemidler.
English: What does the Agency do?
Danish: Hvad laver agenturet?
English: are prepared by the Committee on Herbal Medicinal Products (HMPC) and contain information about what a herbal medicine is used for, restrictions on its use, its undesirable effects and its interactions with other medicines.
Danish: Disse "fællesskabsdrogemonografier" udarbejdes af Udvalget for Plantelægemidler (HMPC) og indeholder oplysninger om, hvad et plantelægemiddel anvendes til, begrænsninger vedrørende dets brug, dets bivirkninger og interaktion med andre lægemidler.
English: In the European Union (EU), advertising of prescription-only medicines directly to patients and consumers is forbidden.
Danish: I EU er det forbudt at reklamere for receptpligtige lægemidler direkte over for patienter og forbrugere.
English: Only medicines evaluated by the Agency are available on the website.
Danish: Der er kun adgang til lægemidler, der er blevet vurderet af agenturet, på webstedet.
English: Why can I not find information about a particular medicine on your website?
Danish: Hvorfor kan jeg ikke finde oplysninger om et bestemt lægemiddel på webstedet?
English: The search is currently only available in English.
Danish: Søgefunktionen findes p.t. kun på engelsk.
English: In addition you may be eligible to take part in a clinical trial.
Danish: Det kan også være, at du er egnet til at deltage i en klinisk undersøgelse.
English: The Agency is not involved in these decisions and does not have any information on pricing or reimbursement arrangements in Member States.
Danish: Agenturet er ikke involveret i disse beslutninger og er ikke i besiddelse af oplysninger om prisfastsættelse eller tilskudsordninger i medlemsstaterne.
English: The Agency is also not in a position to provide medical advice or to confirm whether your symptoms are being caused by your medicine.
Danish: Agenturet er ikke i stand til at yde lægefaglig rådgivning eller bekræfte, om dine symptomer skyldes din medicin eller ej.
English: How are competing interests monitored?
Danish: Hvordan overvåges modstridende interesser?
English: The European Medicines Agency cannot accept side effect reports directly from patients.
Danish: Det Europæiske Lægemiddelagentur tager ikke imod indberetninger af bivirkninger direkte fra patienter.
English: Questions about the Agency
Danish: Spørgsmål om agenturet
English: The Agency also recommends that you report any suspected side effects to the national competent authority.
Danish: Agenturet anbefaler også, at du indberetter eventuelle bivirkninger til den nationale lægemiddelmyndighed.
English: Cosmetics are evaluated by authorities in each Member State.
Danish: Kosmetiske produkter vurderes af myndigheder i den enkelte medlemsstat.
English: Information on medicines authorised in individual Member States through national procedures can only be obtained through the national medicines regulatory authorities.
Danish: Oplysninger om lægemidler, der er godkendt i individuelle medlemsstater ved hjælp af nationale procedurer, kan kun fås gennem de nationale lægemiddelmyndigheder.
English: The Agency cannot advise individual patients on their treatment or condition.
Danish: Agenturet kan ikke rådgive individuelle patienter om deres behandling eller tilstand.
English: How are fees organised at the Agency?
Danish: Hvordan er opkrævningen af gebyrer tilrettelagt hos agenturet?
English: The Agency then sends this recommendation to the European Commission, which takes a binding decision on whether to grant a marketing authorisation.
Danish: Agenturet sender denne anbefaling til Europa-Kommissionen, der så træffer en bindende afgørelse om, hvorvidt der skal udstedes en markedsføringstilladelse.
English: For the Committee for Advanced Therapies, the Committee (CAT) for Orphan Medicinal Products (COMP) and the Paediatric Committee (PDCO), EMA publishes monthly meeting reports in the week following the committee's plenary meeting.
Danish: Hvad angår de månedlige plenarmøder, der afholdes af Komitéen for Avancerede Terapier (CAT), Udvalget for Lægemidler til Sjældne Sygdomme (COMP) og Det Pædiatriske Udvalg (PDCO), offentliggør EMA mødereferater i ugen efter mødeafholdelsen.
English: Does the Agency control advertising of medicines?
Danish: Kontrollerer agenturet reklamer for lægemidler?
English: Medicines cannot be placed on the market without authorisation.
Danish: Lægemidler kan ikke markedsføres, hvis de ikke er godkendt.
English: Can the Agency fund my work?
Danish: Kan agenturet yde finansiel støtte til mit arbejde?
English: The Agency does not have information on sales figures or prescription numbers for any medicine.
Danish: Agenturet har ingen oplysninger om salgstal eller antallet af recepter for nogen lægemidler.
English: How can I get sales figures for a medicine?
Danish: Hvordan kan jeg få salgstallene for et lægemiddel?
English: A medicine that is authorised in the EU might not be authorised or marketed in countries outside the EU.
Danish: Det er ikke sikkert, at et lægemiddel, der er godkendt i EU, er godkendt eller markedsføres i lande uden for EU.
English: No, the Agency is unable to supply pens, mugs or other items branded with the Agency's logo.
Danish: Nej, agenturet kan ikke levere kuglepenne, krus elle andre ting med agenturets logo på.
English: Can the Agency provide me with information on patents on medicines?
Danish: Kan agenturet give mig oplysninger om patenter på lægemidler?
English: No. Advertising of medicines is controlled by medicines regulatory authorities in Member States and other national regulatory bodies, together with self-regulation by the pharmaceutical industry.
Danish: Reklamer for lægemidler kontrolleres af lægemiddelmyndighederne i medlemsstaterne og andre nationale regulerende myndigheder sammen med lægemiddelindustriens selvregulering.
English: The Agency does not maintain a list of medical specialists and is unable to advise individual patients on where to seek treatment.
Danish: Agenturet har ingen liste over speciallæger og kan ikke rådgive individuelle patienter om, hvor de skal søge behandling.
English: • browsing the A-to-Z list of human or veterinary medicines evaluated by the Agency;
Danish: • ved at gennemse den alfabetiske liste over human- eller veterinærmedicinske lægemidler (A-to-Z
English: Contact the medicines regulatory authorities in these countries to get more information on the availability of medicines in their territories.
Danish: Kontakt lægemiddelmyndighederne i disse lande for at få flere oplysninger om adgangen til lægemidler her.
English: Can you help me to get hold of a medicine?
Danish: Kan I hjælpe mig med at få fat på et lægemiddel?
English: How can I get onto a clinical trial?
Danish: Hvordan kan jeg komme med i en klinisk undersøgelse?
English: The Agency's responsibilities are limited to the evaluation of medicines for authorisation purposes and their supervision once they are authorised.
Danish: Agenturets opgaver er begrænset til vurderingen af lægemidler med henblik på godkendelse samt overvågningen af dem, når de er blevet godkendt.
English: Although medicines evaluated by EMA receive an authorisation valid in the whole of the EU, decisions on where a medicine is marketed are made by the company that markets the medicine (the marketing-authorisation holder).
Danish: Selv om EMA udsteder lægemiddelgodkendelser, som er gyldige i hele EU, træffes beslutningen om, hvor et lægemiddel skal markedsføres, af den virksomhed, der markedsfører lægemidlet (indehaveren af markedsføringstilladelsen).
English: Can the Agency give me any advice on my treatment or medical condition?
Danish: Kan agenturet rådgive mig om min behandling eller sygdomstilstand?
English: This means that medicines that have received a central marketing authorisation via the Agency may not be available in all European Union (EU) Member States.
Danish: Det betyder, at lægemidler, der har opnået en central markedsføringstilladelse via agenturet, ikke nødvendigvis fås i alle EU-medlemsstater.
English: The outcome of the Agency's evaluation is used by the European Commission to decide whether a medicine can be authorised for marketing in the European Union (EU).
Danish: Europa-Kommissionen anvender resultatet af agenturets vurdering til at beslutte, om et lægemiddel kan godkendes til markedsføring i EU.
English: If you are experiencing a side effect or think you may be experiencing one, you should seek advice from a doctor or pharmacist.
Danish: Hvis du oplever bivirkninger eller har en formodning om bivirkninger, skal du søge råd hos en læge eller på apoteket.
English: The Agency takes around a year to evaluate a medicine, at the end of which it issues a recommendation on whether the medicine should be approved.
Danish: Det tager omkring et år for agenturet at vurdere et lægemiddel, hvorefter agenturet udsteder en anbefaling om, hvorvidt lægemidlet bør godkendes.
English: The company producing a medicine can only market it once the medicine has received a marketing authorisation from the European Commission.
Danish: En virksomhed, der producerer et lægemiddel, kan først markedsføre lægemidlet, når det har fået en markedsføringstilladelse fra Europa-Kommissionen.
English: You may wish to consult the EU Clinical Trials Register for information on authorised clinical trials that are ongoing.
Danish: Det kan være en god idé at se i EU's register over kliniske undersøgelser for at få oplysninger om igangværende, godkendte kliniske undersøgelser.
English: For the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC), EMA publishes meeting highlights with evaluation outcomes of major public interest on the Friday following their monthly plenary meetings.
Danish: Med hensyn til de månedlige plenarmøder, som Udvalget for Lægemidler til Mennesker (CHMP) og Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC) afholder, offentliggør EMA de væsentligste punkter og vurderingsresultater af offentlig interesse fredagen efter mødeafholdelsen.
English: The medicines regulatory authorities in Member States may be able to provide information on sales of a medicine.
Danish: Lægemiddelmyndighederne i medlemsstaterne vil eventuelt kunne give oplysninger om salget af et lægemiddel.
English: You can also find information on side effects seen with a medicine in the package leaflet.
Danish: Du kan også finde oplysninger om mulige bivirkninger ved et lægemiddel i indlægssedlen.
English: Questions about clinical trials
Danish: Spørgsmål om kliniske undersøgelser
English: The Agency does not have up-to-date information on the availability of medicines in Member States.
Danish: Agenturet har ikke ajourførte oplysninger om adgangen til lægemidler i medlemsstaterne.
English: The Agency suggests that you discuss your treatment with a healthcare professional, such as a doctor or pharmacist.
Danish: Agenturet foreslår, at du drøfter din behandling med en sundhedsmedarbejder som f.eks. lægen eller apoteket.
English: To find information on nationally authorised medicines, contact the medicines regulatory agency in your country;
Danish: For at finde oplysninger om nationalt godkendte lægemidler skal du kontakte lægemiddelmyndigheden i dit land
English: For information on clinical trials, talk to your doctor or nurse.
Danish: Få mere at vide om kliniske undersøgelser hos din læge eller sygeplejerske.
English: To find out if a medicine is currently available in your country through a compassionate-use programme, check with your national medicines regulatory authority or the company responsible for the medicine.
Danish: For at finde ud af, om et lægemiddel aktuelt er tilgængeligt i dit land i forbindelse med et program for anvendelse med særlig udleveringstilladelse, skal du kontakte den nationale lægemiddelmyndighed eller den ansvarlige medicinalvirksomhed.
English: • homoeopathic medicines;
Danish: • Homøopatiske lægemidler
English: The Agency suggests that you discuss these issues with a healthcare professional, such as your doctor or pharmacist.
Danish: Agenturet foreslår, at du drøfter disse spørgsmål med en sundhedsmedarbejder, f.eks. lægen eller apoteket.
English: Questions about medical advice
Danish: Spørgsmål om lægefaglig rådgivning
English: How are cosmetics evaluated?
Danish: Hvordan vurderes kosmetiske produkter?
English: Questions about fees
Danish: Spørgsmål om gebyrer
English: Questions about medicines
Danish: Spørgsmål om lægemidler
English: In the European Union (EU), there are two ways of getting a marketing authorisation for a medicine: the centralised procedure, via the Agency, which results in a single marketing authorisation valid throughout the EU; national authorisation procedures, where individual EU Member States authorise medicines for use in their own territory.
Danish: I EU findes der to måder at få en markedsføringstilladelse for et lægemiddel på: Den centrale procedure, via agenturet, der fører til en enkelt markedsføringstilladelse, som gælder i hele EU
English: The Agency publishes information on the medicines it evaluates at the time it makes a recommendation as well as after the European Commission has issued a marketing authorisation.
Danish: Agenturet offentliggør oplysninger om et vurderet lægemiddel, når det udsteder sin anbefaling, samt når Europa-Kommissionen har udstedt en markedsføringstilladelse.
English: You can also see information on clinical trials ongoing in Europe in the European Union Clinical Trials Register.
Danish: Du kan også finde oplysninger om igangværende kliniske undersøgelser i Europa i EU's register over kliniske undersøgelser på https://www.clinicaltrialsregister.eu/.
English: • patents on medicines;
Danish: • Patenter på lægemidler
English: • food supplements;
Danish: • Kosttilskud
English: Medical devices are evaluated by the medicines regulatory authorities in each Member State.
Danish: Medicinsk udstyr vurderes af lægemiddelmyndighederne i den enkelte medlemsstat.
English: How are medical devices evaluated?
Danish: Hvordan vurderes medicinsk udstyr?
English: Can you recommend a medical specialist for my condition?
Danish: Kan I anbefale en speciallæge, der kan behandle mig?
English: How are food supplements evaluated?
Danish: Hvordan vurderes kosttilskud?
English: Does the Agency have any information on the price or reimbursement of medicines in Member States?
Danish: Har agenturet oplysninger om prisen på eller tilskud til lægemidler i medlemsstaterne?
English: Can the Agency supply me with branded merchandise?
Danish: Kan agenturet levere merchandise med logo på?
English: • medical devices;
Danish: • Medicinsk udstyr
English: This document provides answers to the most frequently asked questions received by the European Medicines Agency (EMA).If the answer to your question is not here, please use our online form: Send a question to EMA.
Danish: Hvis du ikke finder svar på dit spørgsmål her, bedes du benytte vores online-blanket "Send a question to EMA" (send et spørgsmål til EMA).
English: However, some medicines can be supplied to individual patients under special conditions before they have been authorised.
Danish: Nogle lægemidler kan dog udleveres til enkelte patienter under særlige betingelser, inden de er godkendt, f.eks. i forbindelse med kliniske undersøgelser og programmer for anvendelse med særlig udleveringstilladelse, der reguleres af medlemsstaterne.
English: Does the Agency have information on the availability of medicines in Member States?
Danish: Har agenturet oplysninger om adgangen til lægemidler i medlemsstaterne?
English: In the European Union (EU), herbal medicines are authorised by medicines regulatory authorities in Member States.
Danish: I EU godkendes plantelægemidler af lægemiddelmyndighederne i medlemsstaterne.
English: Questions about the availability of medicines
Danish: Spørgsmål om adgangen til lægemidler
English: How are herbal medicines evaluated?
Danish: Hvordan vurderes plantelægemidler?
English: You can do this either by talking to a healthcare professional, or in some cases, you can report the side effects directly to the national competent authority using online patient reporting forms or by telephone.
Danish: I nogle tilfælde kan du også foretage direkte indberetning til den nationale lægemiddelmyndighed ved hjælp af onlineblanketter eller pr. telefon.
English: For information on how to report a side effect in your country, please consult the appropriate authority.
Danish: Du kan få flere oplysninger om, hvordan du indberetter bivirkninger i dit hjemland, ved at tage kontakt til den relevante lægemiddelmyndighed.
English: • the pricing of medicines;
Danish: • Prisfastsættelsen for lægemidler
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English: • the availability of medicines;
Danish: • Adgangen til lægemidler
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English: Medicines regulatory authorities in Member States may be able to provide you with this information.
Danish: Du kan eventuelt få disse oplysninger fra lægemiddelmyndighederne i medlemsstaterne.
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English: • herbal supplements;
Danish: • Urtekosttilskud
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English: The full EPAR for Ivabradine Zentiva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Ivabradine Zentiva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Also, the doctor should consider stopping treatment if the medicine has only a limited effect on reducing symptoms or reducing the heart rate.
Danish: Lægen bør desuden overveje at stoppe behandlingen, hvis lægemidlet kun har en begrænset virkning på symptomerne eller kun i begrænset omfang sænker hjertefrekvensen.
English: Ivabradine Zentiva is available as tablets (5 and 7.5 mg) and can only be obtained with a prescription.
Danish: Ivabradine Zentiva fås som tabletter (5 og 7,5 mg) og udleveres kun efter recept.
English: This is a summary of the European public assessment report (EPAR) for Ivabradine Zentiva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ivabradine Zentiva.
English: The Committee recommended that Ivabradine Zentiva be approved for use in the EU.
Danish: Udvalget anbefalede, at Ivabradine Zentiva godkendes til anvendelse i EU.