FrancophonIA/ELRC3.0 huggingface dataset:
English: It is based on a closelycoordinated regulatory network of national competent authorities in the Member States of the EEA working together with the EMA and the European Commission.
Danish: Det er baseret på et nøje koordineret reguleringsnetværk af nationale kompetente myndigheder i EØS-medlemsstaterne, som arbejder sammen med EMA og Europa-Kommissionen.
English: • scientific support for advanced-therapy medicines;
Danish: • videnskabelig støtte til lægemidler til avanceret terapi
English: • whose authorisation would be in the interest of public or animal health at EU level.
Danish: • hvis godkendelse ville være begrundet i hensynet til folkesundheden eller dyrs sundhed på EU
English: Today, the great majority of new, innovative medicines pass through the centralised authorisation procedure in order to be marketed in the EU.
Danish: I dag gennemgår langt hovedparten af nye, innovative lægemidler den centrale godkendelsesprocedure for at blive markedsført i EU.
English: For more information, see Transparency.
Danish: Yderligere oplysninger: Gennemsigtighed.
English: EMA has encouraged the formation of multinational assessment teams since 2013 for initial marketing authorisation applications.
Danish: EMA har opfordret til oprettelse af internationale vurderingsgrupper siden 2013, for så vidt angår oprindelige ansøgninger om markedsføringstilladelse.
English: The Agency works by:
Danish: Agenturet arbejder ved at:
English: It has a supervisory role with general responsibility for budgetary and planning matters, the appointment of the Executive Director and the monitoring of the Agency's performance.
Danish: Den har en tilsynsfunktion med et generelt ansvar for budget- og planlægningsspørgsmål, udnævnelse af den administrerende direktør og overvågning af EMA's resultater.
English: • suspected side effects reported with medicines;
Danish: • formodede bivirkninger, der er indberettet i forbindelse med lægemidler
English: The Agency screens each expert's declaration of interests (DoI) and assigns each DoI an interest level based on whether the expert has any interests, and whether these are direct or indirect.
Danish: Agenturet screener hver enkelt eksperts interesseerklæring og fastsætter et interesseniveau for hver interesseerklæring ud fra en vurdering af, om eksperten har nogen interesser, og om disse er direkte eller indirekte.
English: It adopts the Agency's financial regulation and its implementing rules, which are binding texts for the Agency, the Board and the Executive Director.
Danish: Den vedtager agenturets finansforordning og gennemførelsesbestemmelserne hertil, som er bindende retsakter for agenturet, bestyrelsen og den administrerende direktør.
English: Under the centralised authorisation procedure, pharmaceutical companies submit a single marketingauthorisation application to EMA.
Danish: I forbindelse med den centrale godkendelsesprocedure indgiver medicinalfirmaerne en ansøgning om en enkelt markedsføringstilladelse til EMA.
English: The Agency's code of conduct extends the requirements for impartiality and the submission of annual DoIs to all staff members working at the Agency.
Danish: Agenturets adfærdskodeks indeholder krav om upartiskhed og årlig indsendelse af interesseerklæringer, der gælder for alle medarbejdere i agenturet.
English: After assigning an interest level, the Agency uses the information provided to determine if an expert's involvement should be restricted or excluded in specific activities of the Agency, such as the evaluation of a particular medicine.
Danish: Efter fastsættelse af et interesseniveau anvender agenturet oplysningerne til at afgøre, om en eksperts deltagelse i specifikke aktiviteter i agenturet, f.eks. vurderingen af et bestemt lægemiddel, bør begrænses eller udelukkes.
English: Tthe Management Board revised its rules on how the Agency handles potential competing interests of staff members in October 2016.
Danish: Bestyrelsen reviderede i oktober 2016 reglerne om, hvordan agenturet håndterer mulige modstridende interesser hos medarbejderne.
English: This allows the marketing-authorisation holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorisation.
Danish: Dette giver indehaveren af markedsføringstilladelsen mulighed for at markedsføre lægemidlet og udlevere det til patienter og sundhedspersoner i hele EU på grundlag af en enkelt markedsføringstilladelse.
English: EMA and the national authorities depend on standards, processes and Information Technology (IT) systems that allow important information on medicines to be shared between European countries and analysed together.
Danish: EMA og de nationale myndigheder baserer sig på standarder, processer og it-systemer, som gør det muligt at udveksle vigtige oplysninger om lægemidler mellem europæiske lande, og at analysere dem sammen.
English: The Agency's policy on the handling of competing interests of scientific experts, including committee members allows the Agency to identify cases where the potential involvement of an expert as a member of a committee, working party or other group or in any other Agency activity needs to be restricted or excluded due to interests in the pharmaceutical industry.
Danish: Agenturets politik for håndtering af modstridende interesser hos videnskabelige eksperter, herunder udvalgsmedlemmer, sætter agenturet i stand til at identificere tilfælde, hvor en eksperts eventuelle deltagelse som medlem af et udvalg, arbejdsgruppe eller anden gruppe eller i en anden af agenturets aktiviteter bør begrænses eller udelukkes på grund af interesser i lægemiddelindustrien.
English: The Agency maintains a public European expert list containing details on all experts who can be involved in EMA work.
Danish: Agenturet vedligeholder en offentlig fortegnelse over europæiske eksperter med oplysninger om alle eksperter, som kan deltage i EMA's arbejde.
English: EMA has in place a breach-of-trust procedure, which sets out how the Agency deals with incorrect or incomplete DoIs by experts and committee members.
Danish: EMA har vedtaget en tillidsbrudprocedure, der fastlægger, hvordan agenturet håndterer ukorrekte eller ufuldstændige interesseerklæringer fra eksperter og udvalgsmedlemmer.
English: Ensuring the independence of its scientific assessments is a high priority for EMA.
Danish: Det er en høj prioritet for EMA at sikre, at dets videnskabelige vurderinger er uafhængige.
English: EMA's Committee for Medicinal products for Human Use (CHMP) or Committee for Medicinal products for Veterinary Use (CVMP) carry out a scientific assessment of the application and give a recommendation on whether the medicine should be marketed or not.
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) eller Udvalget for Veterinærlægemidler (CVMP) foretager en videnskabelig vurdering af ansøgningen og kommer med en anbefaling til, hvorvidt lægemidlet bør markedsføres.
English: EMA brings together scientific experts from across Europe by working closely with the national regulatory authorities in European Union (EU) Member States, in a partnership known as the European medicines regulatory network (For more information, see Chapter 5).
Danish: EMA samler videnskabelige eksperter fra hele Europa ved at arbejde tæt sammen med de nationale regulerende myndigheder i medlemsstaterne i Den Europæiske Union (EU), i et partnerskab kaldet det europæiske netværk for regulering af lægemidler (læs nærmere i Kapitel 5).
English: It has a key role to play in the 'discharge' (sign-off) process of the Agency's accounts by the European Union's budgetary authority.
Danish: Den spiller en central rolle i forbindelse med Den Europæiske Unions budgetmyndigheds decharge (godkendelse) for agenturets regnskab.
English: EMA and its regulatory network partners run a scheme to enable multinational teams to assess applications for human and veterinary medicines.
Danish: EMA og dets netværk af regulatoriske partnere har fastlagt en ordning, der gør det muligt for internationale grupper at vurdere ansøgninger for lægemidler til mennesker og dyr.
English: The policy on handling competing interests for Management Board members and breach-of-trust procedure aligns with the policy on handling competing interests and breach-of-trust procedure for scientific committee members and experts.
Danish: Politikken for håndtering af modstridende interesser hos bestyrelsesmedlemmer og tillidsbrudproceduren er ensrettet med politikken for håndtering af modstridende interesser og tillidsbrudproceduren for medlemmer af videnskabelige udvalg og eksperter.
English: • advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines;
Danish: • lægemidler til avanceret terapi, f.eks. genterapi, somatisk celleterapi eller lægemidler fremstillet ud fra manipuleret væv
English: These national authorities supply thousands of European experts to take part in EMA's scientific committees, working parties and other groups.
Danish: Disse nationale myndigheder stiller flere tusinde europæiske eksperter til rådighed i EMA's videnskabelige udvalg, arbejdsgrupper og andre grupper.
English: These European experts serve as members of the Agency's scientific committees, working parties or in assessment teams supporting their members.
Danish: Disse europæiske eksperter er medlemmer af agenturets videnskabelige udvalg og arbejdsgrupper eller indgår i vurderingshold, der støtter deres medlemmer.
English: • control or have information on pharmaceutical patents.
Danish: • fører ikke tilsyn med og har ingen oplysninger om farmaceutiske patenter.
English: • evaluate applications for the authorisation of clinical trials.
Danish: • vurderer ikke ansøgninger om godkendelse af kliniske undersøgelser.
English: • the mutual-recognition procedure, whereby a marketing authorisation granted in one Member
Danish: • proceduren for gensidig anerkendelse, hvorved en markedsføringstilladelse, der er udstedt i én medlemsstat, kan anerkendes i andre EU-lande
English: Pharmaceutical companies or other medicines developers carry out the research and development of medicines, who then submit the findings and test results for their products to the Agency for evaluation;
Danish: Medicinalfirmaer eller andre lægemiddeludviklere udfører forskningen og udviklingen af lægemidler, og de forelægger derpå konklusionerne og testresultaterne for deres produkter for agenturet til vurdering.
English: • develop treatment guidelines.
Danish: • udarbejder ikke behandlingsretningslinjer.
English: EMA's scientific committees provide independent recommendations on medicines for human and veterinary use, based on a comprehensive scientific evaluation of data.
Danish: EMA's videnskabelige udvalg udarbejder uvildige anbefalinger vedrørende human- og veterinærmedicinske lægemidler på grundlag af en omfattende videnskabelig vurdering af data.
English: Handling competing interests
Danish: Håndtering af modstridende interesser
English: It bases these decisions on:
Danish: Beslutningerne træffes på grundlag af:
English: The concept enables rapporteurs and co-rapporteurs for EMA's scientific committees to include experts from other Member States in their assessment teams.
Danish: Ordningen sætter rapportører og medrapportører for EMA's videnskabelige udvalg i stand til at benytte sig af eksperter fra andre medlemsstater i deres vurderingsgrupper.
English: The network pools resources and expertise in the EU and gives EMA access to thousands of European scientific experts who take part in the regulation of medicines.
Danish: Netværket samler ressourcer og ekspertise i EU og giver EMA adgang til flere tusinde europæiske videnskabelige eksperter, der deltager i reguleringen af lægemidler.
English: They explain the allowable and non-allowable interests for staff, and include controls on the appointment of individuals as responsible for managing the evaluation of medicines.
Danish: Reglerne forklarer, hvilke interesser medarbejdere kan have og hvilke de ikke kan have, og omfatter tilsyn med udnævnelsen af enkeltpersoner som ansvarlige for vurdering af lægemidler.
English: The Agency takes care to ensure that its scientific experts, staff and Management Board do not have any financial or other interests that could affect their impartiality.
Danish: Agenturet søger at sikre, at dets videnskabelige eksperter, personale og bestyrelse ikke har nogen finansielle eller andre interesser, som kan påvirke deres upartiskhed.
English: These bodies are composed of European experts made available by national competent authorities of the EU Member States, which work closely with EMA in the European medicines regulatory network.
Danish: Disse organer består af europæiske eksperter, som stilles til rådighed af EU-medlemsstaternes nationale kompetente myndigheder, der arbejder tæt sammen med EMA i det europæiske netværk for regulering af lægemidler.
English: • control the advertising of medicines.
Danish: • fører ikke tilsyn med reklamer for lægemidler.
English: The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU.
Danish: Det Europæiske Lægemiddelagentur (EMA) er et decentralt agentur i Den Europæiske Union (EU) med ansvar for den videnskabelige vurdering af, tilsyn med og sikkerhedsovervågning af lægemidler, der er udviklet af medicinalfirmaer til brug i EU.
English: • two representatives of patients' organisations;
Danish: • to repræsentanter for patientorganisationer
English: What we don't do
Danish: Hvad er ikke vores opgave?
English: Scientific Committees
Danish: Videnskabelige udvalg
English: • the decentralised procedure, whereby a medicine that has not yet been authorised in the EU
Danish: • den decentrale procedure, hvorved et lægemiddel, der endnu ikke er blevet godkendt i EU, kan blive godkendt i flere EU-medlemsstater på samme tid.
English: National authorisation procedures
Danish: Nationale godkendelsesprocedurer
English: • develop laws concerning medicines.
Danish: • udarbejder ikke lovgivning vedrørende lægemidler.
English: • carry out research or develop medicines.
Danish: • udfører ikke forskning og udvikler ikke lægemidler.
English: • National competent authorities (veterinary)
Danish: • Nationale kompetente myndigheder (veterinærmedicinske lægemidler)
English: • two representatives of the European Parliament;
Danish: • to repræsentanter for Europa-Parlamentet
English: Scientific experts
Danish: Videnskabelige eksperter
English: Organisation chart of the European Medicines Agency
Danish: Organisationsplan for Det Europæiske Lægemiddelagentur
English: The European Medicines Agency (EMA) takes care to ensure that its scientific experts, staff and Management Board do not have any financial or other interests that could affect their impartiality.
Danish: Det Europæiske Lægemiddelagentur søger at sikre, at dets videnskabelige eksperter, personale og bestyrelse ikke har nogen økonomiske eller andre interesser, som kan påvirke deres upartiskhed.
English: The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU.
Danish: Agenturet har ansvaret for den videnskabelige vurdering og overvågning og sikkerhedsovervågningen af lægemidler, der er udviklet af medicinalfirmaer til brug i EU.
English: For more information on the IT systems EMA manages together with the EU Member States, see EU Telematics.
Danish: Yderligere oplysninger om de it-systemer, som EMA forvalter sammen med EU-medlemsstaterne: EU's telematikstrategi.
English: These are available on the EMA website under Management Board members.
Danish: Interesseerklæringerne findes på EMA's websted under Bestyrelsesmedlemmer.
English: The European medicines regulatory network gives EMA access to experts from across the EU, allowing it to bring together the best-available scientific expertise in the EU for the regulation of medicines.
Danish: Det europæiske netværk for regulering af lægemidler giver EMA adgang til eksperter fra hele EU og giver det således mulighed for at trække på den bedst tilgængelige videnskabelige ekspertise i EU i forbindelse med regulering af lægemidler.
English: • two representatives of the European Commission;
Danish: • to repræsentanter for Europa-Kommissionen
English: The mission of the EMA is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the EU.
Danish: Det er EMA's mål at fremme den videnskabelige kvalitet i vurderingen og overvågningen af lægemidler og derigennem beskytte folkesundheden og dyrs sundhed i EU.
English: • one representative of veterinarians' organisations.
Danish: • en repræsentant for dyrelægeorganisationer.
English: Executive Director
Danish: Den administrerende direktør
English: The control of the advertising of non-prescription medicines in the EU is primarily conducted on a self-regulatory basis by industry bodies, supported by the statutory role of the national regulatory authorities in the Member States;
Danish: Kontrollen med reklamer for håndkøbsmedicin i EU sker hovedsageligt gennem selvregulering i brancheforeninger, der bistås af den nationale lægemiddelmyndighed i medlemsstaterne.
English: • issue marketing authorisations.
Danish: • udsteder ikke markedsføringstilladelser.
English: Pooling information
Danish: Indsamling af oplysninger
English: • the oversight of clinical trials;
Danish: • tilsyn med kliniske undersøgelser
English: Its day-to-day operations are carried out by the EMA staff, based inAmsterdam, overseen by EMA's Executive Director.
Danish: Den daglige drift af EMA, der har hjemsted i Amsterdam, forestås af dets personale under tilsyn af den administrerende direktør.
English: Pooling expertise
Danish: Samling af ekspertise
English: • Search veterinary medicines
Danish: • Søgning af veterinærmedicinske lægemidler
English: Scope of the centralised authorisation procedure
Danish: Anvendelsesområdet for den centrale godkendelsesprocedure
English: For more information, see Health-technology-assessment bodies;
Danish: Yderligere oplysninger: Sundhedsteknologivurderingsorganer
English: • evaluate medical devices.
Danish: • vurderer ikke medicinsk udstyr.
English: For more information see:
Danish: Yderligere oplysninger:
English: Breach-of-trust procedure
Danish: Tillidsbrudprocedure
English: Multinational assessment teams
Danish: Internationale vurderingsgrupper
English: • National competent authorities (human)
Danish: • Nationale kompetente myndigheder (humanmedicinske lægemidler)
English: For more information see Pharmacovigilance.
Danish: Yderligere oplysninger: Lægemiddelovervågning.
English: Centralised authorisation procedure
Danish: Central godkendelsesprocedure
English: • Search human medicines
Danish: • Søgning af humanmedicinske lægemidler
English: For more information see European Commission: Medicinal products for human use;
Danish: Yderligere oplysninger: EuropaKommissionen: Lægemidler til mennesker
English: Agency staff
Danish: Agenturets personale
English: • orphan designation of medicines for rare diseases;
Danish: • udpegelse af lægemidler til sjældne sygdomme
English: The completed DoIs for management staff are available on the EMA website under Agency structure.
Danish: De udfyldte interesseerklæringer for ledende medarbejdere kan ses på EMA's websted under Agenturets organisation.
English: • one representative of doctors' organisations;
Danish: • en repræsentant for lægeorganisationer
English: Management Board
Danish: Bestyrelse
English: For more information, see Medical devices.
Danish: Yderligere oplysninger: Medicinsk udstyr.
English: EMA does not:
Danish: EMA:
English: What we do
Danish: Hvad er vores opgave?
English: Management Board members
Danish: Bestyrelsesmedlemmer
English: • orphan medicines (medicines for rare diseases);
Danish: • lægemidler til sjældne sygdomme
English: • the nature of the interests declared;
Danish: • de oplyste interessers art
English: Complete control by day is illustrated below.
Danish: Fuldstændig kontrol pr. dag er illustreret nedenfor.
English: Symptomatic treatment should be given.
Danish: Der bør gives symptomatisk behandling.
English: This medicine should not be used by children or adolescents under 18 years.
Danish: Dette lægemiddel bør ikke anvendes til børn eller teenagere under 18 år.
English: *Spontaneous reports
Danish: *Spontane rapporter
English: This redness should go away over time.
Danish: Denne rødme bør gå væk med tiden.
English: If it does not, tell your doctor.
Danish: Hvis den ikke gør det, skal du fortælle det til lægen.
English: Exposure to sunlight
Danish: Eksponering over for sollys
English: Plasma protein binding is approximately 65%.
Danish: Plasmaproteinbindingsgraden er ca. 65 %.
English: Any increase in corticosteroid use during the study was reported as rescue treatment.
Danish: Al øget kortikosteroid-anvendelse i løbet af studiet blev rapporteret som nødbehandling.
English: The safety and efficacy of SANCUSO in children aged 0 to 18 years have not yet been established.
Danish: SANCUSO's sikkerhed og virkning hos børn i alderen 0 til 18 år er endnu ikke klarlagt.
English: The remainder of the dose is excreted as metabolites, with 49% in the urine and 34% in the faeces.
Danish: Den resterende dosis udskilles som metabolitter, 49 % i urinen og 34 % i fæces.
English: - Use only one transdermal patch at a time.
Danish: - Brug kun et depotplaster ad gangen.
English: These data help to clarify the mechanisms by which some of the ECG changes (particularly QT and QRS prolongation) associated with this class of substance can occur.
Danish: Disse data hjælper med at give klarhed over de mekanismer, hvorved nogle af EKG-ændringerne (især QT- og QRS-forlængelse), der er forbundet med denne stofklasse, kan opstå.
English: Constipation is a common side effect and may affect up to 1 in 10 people.
Danish: Forstoppelse er en almindelig bivirkning og kan forekomme hos op til 1 ud af 10 personer.
English: Granisetron distributes freely between plasma and red blood cells.
Danish: Granisetron distribueres frit mellem plasma og de røde blodlegemer.
English: This medicine is for transdermal use.
Danish: Dette lægemiddel er til transdermal anvendelse.
English: Date of first authorisation: 20 April 2012 Date of latest renewal: 9 January 2017
Danish: Dato for seneste fornyelse: 9. januar 2017.
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERINGOG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Within the system organ class, the adverse reactions are listed by frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: Inden for systemorganklassen er bivirkninger opstillet ifølge hyppighed ved hjælp af den følgende konvention: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: In the event of overdose, the transdermal patch should be removed.
Danish: I tilfælde af overdosering skal depotplastret fjernes.
English: Other possible side effects associated with granisetron products (frequency not known):
Danish: Andre bivirkninger associeret med granisetron-produkter (hyppighed ikke kendt):
English: The mean plasma half-life in healthy subjects is 4-6 hours and in patients is 9-12 hours.
Danish: Den gennemsnitlige halveringstid i plasma hos raske personer er 4-6 timer, og hos patienter er den 9-12 timer.