natgillin/translations-raw huggingface dataset:
Underretning af apotekerne om forbrugerpriser m.v. på apoteksforbeholdte lægemidler 
Notification of consumer prices, etc. of pharmacy-only medicinal products to the pharmacies.
Anmeldelse af medicinpriser 
Notification of medicine prices
anmeldelse af priser på lægemidler 
notification of medicine prices,
Præcisering af krav om godkendelse af leverandører 
Notification of medicines supply failure
Anmeldelse af pris og (hvis påkrævet) leveringsevne for en pakning. 
Notification of price and (if required) a supply estimate for a package.
Anmeldelse af priser og pakninger på cannabismellemprodukter via DKMAnet 
Notification of prices and packages of cannabis intermediate products via DKMAnet
Anmeldelse af priser og sortiment via DKMAnet 
Notification of prices and range via DKMAnet
Orientering af fremstiller 
Notification to manufacturer
Notifikationer i øvrigt. 
Notifications in general.
Anmeldelser om klassifikation af lokaler til genterapi og anmeldelse af projekter om anvendelse af levende, genetisk modificerede mikroorganismer til genterapi indsendes til Arbejdstilsynet, der så sender en kopi af anmeldelserne til høring i Miljøstyrelsen. 
Notifications on the classification of premises for gene therapy and notification of projects concerning the use of living, genetically modified microorganisms for gene therapy are to be submitted to the Danish Working Environment Authority, which will then send a copy of notifications for consultation to the Danish Environmental Protection Agency.
Anmeldelse i forbindelse med midlertidig eller lejlighedsvis ansættelse som farmaceut på et dansk apotek eller sygehusapotek skal fornys hvert år, såfremt du ønsker muligheden for denne type ansættelse opretholdt. 
Notifications related to the provision of temporary or occasional services as a pharmacist at a Danish pharmacy or hospital pharmacy, must be renewed once a year if you wish to maintain the possibility of providing such activities.
Orientering af Lægemiddelstyrelsen 
Notifications to the Danish Medicines Agency
Anmeldelser, som kan overføres med XML-fil 
Notifications, which may be transferred by an XML file
Notified bodies (bemyndigede organer) 
Notified Bodies
Bemyndigede organer er bemyndiget af myndighederne til at sikre, at fabrikanter af medicinsk udstyr har den påkrævede tekniske dokumentation og kvalitetskontrol for processer og produkter, der indebærer en væsentlig risiko. 
Notified bodies are authorised by the authorities to ensure that manufacturers of medical devices have the required technical documentation and perform quality control for processes and products that may pose a significant risk.
Bemyndigede organer er ansvarlige for at vurdere medicinsk udstyr i mellem- og højrisikoklassen , før produkterne kan markedsføres i EU. 
Notified bodies are responsible for assessing medium-risk and high-risk medical devices before the products can be placed on the market in the EU.
Bemyndigede organer er ansvarlige for at vurdere medicinsk udstyr i mellem- og højrisikoklassen, før produkterne kan markedsføres i EU. 
Notified bodies are responsible for assessing medium-risk and high-risk medical devices before the products can be placed on the market in the EU.
De bemyndigede organer skal opbevare oplysninger om dyrenes geografiske oprindelse. 
Notified bodies shall retain information on the geographical origin of the animals.
Anmeldte forsøg fordelt på terapiområder MedDRA1 kode for terapiområde 
Notified trials by therapeutic area MedDRA1 therapeutic area code
Anmeld eller ansøg om tilladelse før tilknytningen starter 
Notify or apply for permission before you establish a relationship
Anmeld eller ansøg om tilladelse til tilknytning (blanket) 
Notify or apply for permission to establish a relationship (e-form) (in Danish only)
Anmeld økonomisk støtte (blanket) 
Notify us about financial support (e-form) (in Danish only)
Anmeld økonomisk støtte fra en virksomhed – brug denne blanket 
Notify us about financial support from a company – use this form
Navneordenes former, grundled i ubestemt form 
Noun forms, subject in the indefinite form
Navneordenes former: ubestemt til bestemt 
Noun forms: indefinite to definite
Novartis anfører, at det er vanskeligt at forstå, at Lægemiddelstyrelsen i én afdeling strengt håndhæver, at lægemiddelfirmaer på ingen måde må promovere lægemidler uden for indikationsområdet, når Medicintilskudsnævnet grupperer lægemidlerne uden respekt for de forskellige indikationer. 
Novartis states that it is difficult to understand that the Danish Medicines Agency in one department strictly enforces the ban to promote medicinal products outside the indication area by pharmaceutical companies when the Committee groups the medicinal products without consideration being given to the different indications.
Novartis skriver, at Lægemiddelstyrelsen er forpligtet til at sikre at hensyn til compliance inddrages i afgørelsen. 
Novartis states that the Danish Medicines Agency is under an obligation to ensure that considerations for compliance are included in the decision.
Novartis skriver, at introduktion af generisk konkurrence ikke kan begrunde, at patienter, som har et særligt behandlingsmæssigt behov, ikke længere skal have mulighed for at få ordineret lægemidler med valsartan eller aliskiren. 
Novartis states that the introduction of generic competition cannot justify that it will no longer be possible to prescribe medicinal products containing valsartan or aliskiren to patients with specific treatment needs.
Nu er endnu en medarbejder fra Lægemiddelstyrelsens Afdeling for Forbrugersikkerhed 
Now yet another member of staff from the Danish Medicines Agency's
Lægemiddelstyrelsen har nu gennemgået tilskudsstatus for alle lægemidler mod halsbrand, sure opstød og mavesår med dette formål for øje. 
Now, the Danish Medicines Agency has reassessed the reimbursement status of all drugs for heartburn, sour eructations and ulcers with this aim in view.
Lægemiddelstyrelsen har nu gennemgået hjerte-karlægemidlernes tilskudsstatus med dette formål for øje. 
Now, the Danish Medicines Agency has reassessed the reimbursement status of cardiovascular medicinal products with this aim in view.
Nplate® (romiplostim) kan øge risikoen for sygdomsprogression, hvis det anvendes til patienter med myelodysplastisk syndrom (MDS) 
Nplate® (romiplostim) may increase the risk of disease progression in patients with myelodysplastic syndrome (MDS)
NSAID og mulig risiko for hjertebivirkinger 
NSAIDs and possible risk of cardiac adverse reactions
Nulojix® (belatacept) og øget hyppighed af akut transplantatafstødning i nogle specifikke tilfælde, side 4 
Nulojix® (belatacept) and increased incidence of acute graft rejection in certain specific cases (p 4)
Antal i 2005 
Number in 2005
Antal 
Number of
Antal indberetninger med angivelse af batchnr. 
Number of ADR reports providing batch number
Antal indberetninger med angivelse afbatchnummer. 
Number of ADR reports with indication of batch number
Antal ansøgninger om generelt tilskud 
Number of applications for general reimbursement
Antal ansøgninger om generelt tilskud behandlet af nævnet pr. månedligt møde i 2010. 
Number of applications for general reimbursement reviewed by the Committee per monthly meeting held in 2010.
Antal ansøgninger om generelt tilskud behandlet af nævnet pr. månedligt møde i 2009. 
Number of applications for general reimbursement reviewed by the Committee per monthly meeting in 2009.
Antal ansøgninger om individuelt tilskud 
Number of applications for individual reimbursement
Antallet af ansøgninger om individuelle tilskud til lægemidler i 2008 
Number of applications for individual reimbursement of medicinal products in 2008
Antallet af ansøgninger om individuelle tilskud til lægemidler i 2010 
Number of applications for individual reimbursement of medicines in 2010
Antallet af individuelle tilskudsansøgninger behandlet af nævnet pr. månedligt møde i 2009. 
Number of applications for individual reimbursement reviewed by the Committee per monthly meeting held in 2009.
Antallet af individuelle tilskudsansøgninger behandlet af nævnet pr. månedligt møde i 2010. 
Number of applications for individual reimbursement reviewed by the Committee per monthly meeting held in 2010.
Ansøgninger om individuelle tilskud, 2000-2006 
Number of applications for individual reimbursement, 2000-2006
Antal ansøgninger om individuelle tilskud 2002-2008 
Number of applications for individual reimbursement, 2002-2008
Status over antal ansøgninger om individuelle tilskud til lægemidler i 2006 
Number of applications submitted for individual reimbursement of medicinal products in 2006
Antal godkendte butikker 
Number of authorised shops
Antal sager i EU 
Number of cases in the EU
Antal sager med DK som deltager 
Number of cases with Danish participation
Antal sager med DK som deltager 
Number of cases with DK as participant
Antal sager med DK som referenceland 
Number of cases with DK as RMS
Antal sager uden DK som deltager 
Number of cases without DK as participant
kode for terapiområde 
Number of clinical trials
Til gengæld er neurologiske 
Number of clinical trials
Antal kliniske forsøg anmeldt til Lægemiddelstyrelsen År 
Number of clinical trials notified to the Danish Medicines Agency Year
Antal eksemplarer 
Number of copies
Antal DCP procedurer 
Number of DCP procedures
Antal ansatte 
Number of employees
Antal brugere af Fampyra® og indberettede bivirkninger 
Number of Fampyra® users and reported adverse reactions
Antal raske forsøgspersoner 
Number of healthy trial subjects
Antal humane DCP procedure 
Number of human DCP procedures
Antal humane DCP procedurer 
Number of human DCP procedures
Antal humane MRP procedurer 
Number of human mutual recognition procedures
Antal humane centrale procedurer 
Number of human procedures
Antal inspektioner fra 2005 til 2010 
Number of inspections in the period 2005 to 2010
Antal inspektioner af håndkøbsudsalg Politianmeldelser heraf 
Number of inspections of OTC outlets - of which reported to the police
Antal inspektioner af detailudsalg Politianmeldelser heraf Fordelt på tilladelsestyper: 
Number of inspections of retail outlets - of which reported to the police Broken down by type of authorisation:
Antal medlemmer 
Number of members
antal pakninger 
number of packages
Antal patienter i Danmark 
Number of patients in Denmark
Antal personer 
Number of people
Antal personer i behandling med misoprostol (A02BB01) 
Number of people teated with misoprostol (A02BB01)
Antal personer i behandling med antacida fraset magnesiumoxid (A02A) 
Number of people treated with antacids except magnesium hydroxides (A02A)
Antal personer i behandling med H2-receptor antagonister (A02BA) 
Number of people treated with H2-receptor antagonists (A02BA)
Antal personer 
Number of persons
Antal indberetninger af produktfejl 2006-2009 
Number of product defect reports from 2006-2009
Antal indberetninger 
Number of reports
Indberetninger om forfalskede lægemidler i perioden 2003-2007 
Number of reports about counterfeit medicinal products in the period 2003-2007.
Antal indberetninger af produktfejl 2006‐2010 
Number of reports involving product defects from 2006‐2010
Antal indberetninger om forfalskede lægemidler i perioden 2003-2008 
Number of reports of counterfeit medicines in the period 2003-2008.
Antal indberetninger om forfalskede lægemidler i perioden 2004-2009 
Number of reports of counterfeit medicines in the period 2004-2009.
Antal indberetninger af produktfejl 2005-2008 
Number of reports of product defects 2005-2008
Antal indberetninger af produktfejl 2002-2005 
Number of reports on product defects 2002-2005
Antal alvorlige indberetninger 
Number of serious ADR reports
Antal alvorlige indberetninger 
Number of serious reports
Antal formodede bivirkninger indberettet om de enkelte vacciner i andet halvår af 2013. 
Number of suspected adverse reactions reported for individual vaccines in the second half of 2013.
Skeletal malformation NOS 
Number of trials
Antal sager med DK som deltager 
Number of trials with DK as participant
Antal sager med DK som reference 
Number of trials with DK as RMS
Antal sager uden DK som deltager 
Number of trials without DK as participant
Antal forsøg Antal deltagere 
Number of trialsNumber of trial subjects
Antal valide ansøgninger 
Number of valid applications
Antal veterinære DCP procedurer 
Number of veterinary DCP procedures
Antal veterinære MRP procedurer 
Number of veterinary mutual recognition procedures
Antal veterinære centrale procedurer 
Number of veterinary procedures
Antal tilbagekaldelser 
Number of withdrawals
Antal tilbagekaldelser i perioden 2004-2009 
Number of withdrawals from 2004-2009
Antal tilbagekaldelser i perioden 2006-2011 
Number of withdrawals from 2006-2011
Antal tilbagekaldelser i perioden 2002-2005. 
Number of withdrawals in the period 2002-2005.
Antal tilbagekaldelser i perioden 2002-2008 
Number of withdrawals in the period 2002-2008.
Antal forfalskede lægemidler i perioden 2003-2006 
Number of withdrawals in the period 2003-2006.
Tal kan kun indgå i navne for kombinationspræparater. 
Numbers can only be included in names of combination products.
Sygeplejersker 
Nurses
sygeplejersker med tilknytning til medicovirksomhed 
nurses having a relationship with a medical device company
sygeplejerskers tilknytning til medicovirksomheder 
nurses having a relationship with medical device companies
Sygeplejersker skal kun indberettes af medicovirksomheder. 
Nurses should only be reported by medical device companies.
Sygeplejersker i klinisk arbejde i Danmark er kun omfattet ved tilknytning til medicovirksomheder. 
Nurses undertaking clinical duties in Denmark are only covered by the notification duty if they have relationships with medical device companies.
Sygeplejersker i hjemmeplejen oplever, at administreringen af medicin er besværliggjort, da patientens medicin findes flere steder dels som dosisdispenseret medicin og dels som almindelig medicin. 
Nurses working in the home nursing services experience that medicine management has become more difficult because the patient's medicine is located in different places, either in the form of dose dispensed medicine or in the form of ordinary medicine.
Sygeplejerskers tilknytning til medicovirksomheder 
Nurses' association with medical companies
Sygeplejersker inkl. studerende 
Nurses, incl. students
o Fremstilling og/eller indførsel af lægemidler og mellemprodukter o Engrosforhandling af lægemidler inden for EU/EØS o Detailforhandling af ikke-apoteksforbeholdte lægemidler uden for apotek, herunder 
o Manufacture and/or importation of medicines and intermediates o Wholesale distribution of medicines within the EU/EEA o Retail sale of non-pharmacy restricted medicines outside pharmacies, including over-the-counter
Der anføres indvendinger mod præparatskift, herunder risiko for manglende blodtrykskontrol og komplikationer som følge heraf og risiko for bivirkninger ligesom præparatskift af velbehandlede patienter generelt beklages. 
Objections are raised against changes of product, including the risk of lacking blood-pressure control and consequent complications as well as the risk of adverse reactions, and general regrets are raised concerning change of product for well-treated patients.
Mål og indsatser 
Objectives and focus areas
Mål og indsatsområder 
Objectives and focus areas
Pligt til at meddele os, når medarbejderantallet overstiger 500 
Obligation to inform us if the number of employees exceeds 500
Pligt til indberetning om alvorlige forsyningsvanskeligheder for lægemidler 
Obligation to report serious medicine supply difficulties
Pligt til at behandle syge dyr/fisk 
Obligation to treat sick animals/fish
profilering, bør dog være tilladt, når EU-ret eller medlemsstaternes nationale ret, som den dataansvarlige er 
obligation to which the controller is subject or for the performance of a task carried out in the public interest or
Forpligtelser ved opdatering af active substance master files (ASMF/DMF) 
Obligations regarding updates of Active Substance Master Files (ASMF/DMF)
Obs. Hvis du søger data for sygehussektoren og ATC kode L01 eller J01 er der vigtig information, du bør læse i ”Datagrundlag og beskrivelse” under punktet ”Fejlindberetninger, afvigelser mv." 
Obs. If you are searching data for the hospital sector and ATC code L01 or J01 you are advised to read the important information in "Data basis and description" in the section "Reporting errors, deficiencies etc."
forbindelse med behandlingen, deres vurdering med hensyn til risikoens oprindelse, karakter, sandsynlighed og 
obtain human intervention, to express his or her point of view, to obtain an explanation of the decision reached
Rekvirering af EudraCT-nummer 
Obtaining a EudraCT number
Vi har naturligvis pligt til at sikre os, at oplysningerne er korrekte og valide, før vi træffer beslutning om fx at suspendere en markedsføringstilladelse. 
Obviously, we are obliged to ensure that the information is correct and valid before we can make a decision about e.g. the suspension of a marketing authorisation
Opstået indenfor 180 dage efter HPV-vaccine 
Occurring within 180 days after HPV vaccine administration
tredjeland, hvor den dataansvarlige er etableret, i sig selv er utilstrækkeligt til at fastslå en sådan hensigt, kan 
of a language generally used in the third country where the controller is established, is insufficient to ascertain
EU-retten eller medlemsstaternes nationale ret bør inden for rammerne af denne forordning fastsætte 
of academic, artistic or literary expression should be subject to derogations or exemptions from certain
Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC)) reviderede anbefalinger for brugen af betablokkere som førstevalg til hypertension. 
of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC)) have revised the recommendations for the use of beta blocking agents as first-line treatment for hypertension.
modstå utilsigtede hændelser eller ulovlige eller ondsindede handlinger, som kompromitterer tilgængeligheden, 
of confidence, accidental events or unlawful or malicious actions that compromise the availability, authenticity,
dataansvarlige ikke kan begrænse ved passende foranstaltninger med hensyn til tilgængelig teknologi og 
of data protection by design and by default should also be taken into consideration in the context of public
Garantierne bør navnlig vedrøre overholdelse af de generelle principper for 
of expert knowledge should be determined in particular according to the data processing operations carried out
Hvis sagen kræver yderligere undersøgelse eller koordinering med en anden tilsynsmyndighed, bør den registrerede undervejs underrettes herom. 
of investigation, corrective powers and sanctions, and authorisation and advisory powers, in particular in cases of
retsafgørelser eller administrative myndigheders afgørelser i tredjelande, der kræver, at en dataansvarlig eller en 
of monitoring and of carrying out the periodic reviews, the Commission should take into consideration the views
Af rent patientsikkerhedsmæssige grunde vil tilføjelse af f.eks. styrken for et kombinationspræparat dog i særlige tilfælde kunne accepteres. 
Of patient safety reasons, addition of, e.g., the strength of a combination product may be accepted in a few special cases.
sammenhængsmekanismen og derefter vedtaget af Kommissionen. 
of personal data and affects a large number of data subjects.
ingen af de andre grunde til overførsel kan finde anvendelse. 
of Personal Data and its Additional Protocol should be taken into account.
resultat eller personoplysningerne ikke anvendes til støtte for foranstaltninger eller afgørelser, der vedrører 
of personal data to third countries or international organisations, the independent supervisory authorities,
nødvendig og forholdsmæssig for at sikre overholdelse af denne forordning, idet der tages hensyn til 
of public interest recognised in Union or Member State law to which the controller is subject.
Af de 117 hændelser er de fire hyppigste forvekslinger: 
Of the 117 events, the four most common mix-ups are:
Ud af de 122 prøver blev 64 screenet for indhold af nikotin ved hjælp af en modificeret Ph.Eur. 
Of the 122 samples, 64 e-cigarettes were screened for nicotine using a modified Ph. Eur.
Af de 72 i kolonnen ”ikke acceptabel” i andet halvår 2010 er 42 virksomheder politianmeldt. hvilket svarer til 6,0 % af det samlede antal inspektioner i 2010. 
Of the 72 that were rated 'Unacceptable' in the second half of 2010, 42 companies were reported to the police, which corresponds to 6.0 % of the total number of inspections in 2010.
dets/dens anvendelsesområde, jf. retspraksis fra Den Europæiske Unions Domstol (»Domstolen«) og Den 
of the European Union (the ‘Court of Justice') and the European Court of Human Rights.
Af de godt 550.000 personer, der er i behandling med et diuretikum, var ca. 318.000 personer i behandling med kombinationen af bendroflumethiazid og kalium og ca. 170.000 personer i behandling med furosemid. 
Of the more than 550,000 persons being treated with a diuretic, approx. 318,000 persons were treated with the combination of bendroflumethiazide and potassium and approx. 170,000 persons with furosemide.
for mikrovirksomheder og små og mellemstore virksomheder indeholder denne forordning en undtagelse for 
of the specific situation of micro, small and medium-sized enterprises, this Regulation includes a derogation for
Dette bør omfatte specifik behandling, der foretages på tilsynsmyn­ 
of the supervisory authority, the member or members should act with integrity, refrain from any action that is
forpligtelse eller udførelse af en opgave i samfundets interesse eller henhørende under offentlig myndigheds­ 
of the term ‘racial origin' in this Regulation does not imply an acceptance by the Union of theories which
Af de 160 indberetninger resulterede 37 % i tilbagekaldelser af lægemidler fra det danske marked eller eksportmarkedet. 
Of the total of 160 reports, 37 % resulted in withdrawals of medicinal products from the Danish market or the export market.
Af de 196 indberetninger resulterede 28% i tilbagekaldelser af lægemidler fra det danske marked 
Of the total of 196 reports, 28% resulted in withdrawals of medicinal products from the Danish market.
Af de 202 indberetninger om produktfejl i 2007 resulterede 28 % i tilbagekaldelser af lægemidler fra det danske marked. 
Of the total of 202 reports on product defects that we received in 2007, 28% resulted in withdrawals of medicinal products from the Danish market.
Af disse er 549 (62 %) ansøgninger til 69 (23 %) forskellige patienter indsendt af den samme læge. 
Of these, 549 (62 %) applications for 69 (23 %) different patients were submitted by the same doctor.
Off label-behandling er et udbredt fænomen i Danmark og i resten af verden. 
Off-label treatment is widespread in Denmark and the rest of the world.
genstand og varighed, behandlingens karakter og formål, typen af personoplysninger og kategorierne af 
offences or related security measures; where personal aspects are evaluated, in particular analysing or predicting
tilsynsmyndigheden, i overensstemmelse med retningslinjer, der er udstukket af denne eller af andre relevante 
offences, and is unlikely to result in a risk to the rights and freedoms of natural persons, taking into account the
vedrører udbud af varer eller tjenesteydelser til sådanne registrerede, uanset om de er knyttet til en betaling. 
offering goods or services to such data subjects irrespective of whether connected to a payment.
alvorlige trusler mod sundheden. 
official authority vested in the controller.
myndighedsudøvelse, bør behandlingen have retsgrundlag i EU-retten eller medlemsstaternes nationale ret. 
official authority, the processing should have a basis in Union or Member State law.
Der indgår ofte mange andre symptomer i indberetningerne, og der foreligger ikke en egentlig diagnose i forbindelse hermed. 
Often, the ADR reports describe many other symptoms with no actual diagnosis being made.