natgillin/translations-raw huggingface dataset:
Rotarix og RotaTeq® og risiko for intussusception 
Rotarix and RotaTeq® and risk of intussusception
Der skal ikke indsendes rutinemæssige periodiske sikkerhedsopdateringer for følgende lægemidler: 
Routine periodic safety update reports are not required for the following medicinal products:
Rudolf Albert Scheller, speciallæge i intern medicin og geriatri 
Rudolf Albert Scheller, specialist in internal medicine and geriatrics
Regler om cannabis 
Rules about cannabis
European Commission - EU logo for online sale of medicines 
Rules about pharmacies' and authorised retailers' online sale of medicines
Regler om apotekers og godkendte detailforhandleres onlinesalg af medicin 
Rules about pharmacies' and authorised retailers' online sale of medicines
Regler om tilknytning for virksomheder omfattet af forsøgsordning 
Rules about relationships applicable to companies comprised by the pilot programme
Regler om tilknytning for virksomheder 
Rules about relationships to companies
Regler og vejledning 
Rules and guidelines
Regler og love 
Rules and legislation
Love og regler for Sundheds- og Ældreministeriet på retsinformation.dk 
Rules and legislation for the Danish Ministry of Health at retsinformation.dk (in Danish)
Love og regler for Sundheds- og Ældreministeriet på retsinformation.dk - november 2011 og tidligere 
Rules and legislation for the Danish Ministry of Health at retsinformation.dk - November 2011 and before (in Danish)
Regler for aktive stoffer (API) 
Rules applicable to active substances (APIs)
b) regler for ledsagende behandling/medicinering før og/eller under forsøget (inkl. "rescue medicine"), 
Rules for concomitant treatment/medication before and/or during the trial (including "rescue medicine")
Regler for produktion, import, salg, udlevering og brug af medicin til dyr 
Rules governing manufacturing, importation, distribution, dispensing and use of veterinary medicines
Regler for privates køb af medicin i udlandet 
Rules governing private individuals' purchases of medicines abroad
Forretningsorden 
Rules of procedure
Regler for tilknytning i forbindelse med deltagelse i paneldebatter 
Rules on relationships in connection with participation in panel debates
Regler for tilknytning ved deltagelse i paneldebatter 
Rules on relationships in connection with participation in panel debates
REGLER: 
RULES:
RUP (Repeat Use Procedure) For ansøgninger om markedsføringstilladelser i andre EU/EØS-lande gennem den gensidige anerkendelsesprocedure (MRP), og hvor Danmark har rollen som referenceland (RMS) er der følgende gebyrer: 
RUP (Repeat Use Procedure) Applications for marketing authorisations in other EU/EEA countries through the mutual recognition procedure (MRP) with Denmark as Reference Member State (RMS) are subject to the following fees:
RUP straks efter afsluttet DCP/MRP 
RUP immediately after completed DCP/MRP
Pose/brev: Lille pose af vævet papir eller kunststof (som tepose), indeholdende enkeltdosis lægemiddel. 
Sachet/bag: Small sachet of woven paper or synthetic material (such as a tea bag), containing a single dose of the medicine.
Vi har desværre eksempler på, at ulovlig medicin bliver lavet under uhygiejniske forhold og indeholder andet end det, der står på etiketten. 
Sadly, there are many examples of illegal medicines being manufactured under unhygienic conditions and containing anything but what is on the label.
Garantier og undtagelser i forbindelse med behandling til arkivformål i samfundets interesse, til videnskabelige eller historiske forskningsformål eller til statistiske formål 
Safeguards and derogations relating to processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes
udpege den tilsynsmyndighed, der fungerer som fælles kontaktpunkt for disse myndigheders effektive deltagelse i 
safeguards may consist of making use of binding corporate rules, standard data protection clauses adopted by the
Overvågning af sikkerheden i forbindelse med ændring fra Gardasil® til Cervarix® som HPV-vaccine i børnevaccinationsprogrammet, side 3 
Safety monitoring following switch from Gardasil® to Cervarix® as HPV vaccine in the childhood immunisation programme, page 3
Sikkerheden ved botulinumtoksin (Botox® m.fl.) og fillers til kosmetisk behandling, side 6 
Safety of products containing botulinum toxin (Botox® etc.) and fillers for cosmetic treatment, page 6
sikkerhedsprocedurer, fx komitéer. 
safety procedures, e.g. committees.
Overvågning af godkendt klinisk forsøg 
Safety surveillance of authorised clinical trial
Sikkerhedsopdateringsrapporter 
Safety update reports
Safetyvariationer er ikke blevet indsendt indenfor acceptable tidsfrister 
Safety variations were not submitted within the acceptable deadlines
Salg af medicin uden for apotek 
Sale of medicine outside pharmacies
Forhandling af lægemidler fra 
Sale of medicines from pharmacies
Forhandling af lægemidler fra apotek 
Sale of medicines from pharmacies
Salg af medicin uden for apotek 
Sale of medicines outside pharmacies
Salg af håndkøbslægemidler via internettet 
Sale of OTC medicines online
Salg eller udlevering af medicin kræver en markedsføringstilladelse 
Sale or dispensing of medicine requires a marketing authorisation
Salg/oplagring af gasser til medicinsk brug beregnet til salg/distribution direkte til forbrugeren/patienten kræver detailtilladelse (jf. § 4 i bekendtgørelse nr. 1318 af 27. november 2007, om gasser til medicinsk brug). 
Sale/storage of medical gases intended for sale/distribution directly to the consumer/patient requires an authorisation for retail sale (cf. section 4 of executive order no. 1318 of 27 November 2007 on medical gases).
Salget sker ofte over nettet og på tværs af landegrænser. 
Sales often take place over the internet and across geographical borders.
Salgssteder i alt 
Sales outlets in total
samme materialer i kontakt med væv eller kropsvæsker 
same materials in contact with tissue or body fluids
Samme formodede risiko som for paroxetin 
Same risk as suspected for paroxetine
Sara har bred erfaring med politikudvikling, EU-regulering og implementering i dansk lovgivning samt EU- og internationalt samarbejde. 
Sara has extensive experience with policy development, EU regulation and implementation into Danish law and with EU and international collaboration.
Sara har tidligere arbejdet i bl.a. Udlændinge- og Integrationsministeriet, Undervisningsministeriet og Miljø- og Fødevareministeriet. 
Sara has previously worked in the Ministry of Immigration and Integration, the Ministry of Education and the Ministry of Environment and Food of Denmark.
Sara Westengaard Guldagger tiltrådte som enhedschef for det nye ledelsessekretariat den 1. august 2018. 
Sara Westengaard Guldagger joined as Director of Division of the new Directors’ Office on 1 August 2018.
Tilfredsstillende Ikke tilfredsstillende 
Satisfactory Unsatisfactor y
Tilfredsstillende/ Mindre tilfredsstillende 
Satisfactory/ Less satisfactory
Sativex indeholder cannabisekstrakter og er et godkendt lægemiddel i Danmark. 
Sativex contains cannabis extracts and is an authorised medicine in Denmark.
Sativex indeholder cannabisekstrakter og kan udskrives af speciallæger i neurologi til patienter med multipel sklerose. 
Sativex contains cannabis extracts and may be prescribed by neurologists to patients with multiple sclerosis.
Sativex har været igennem den officielle godkendelsesproces og er derfor blevet testet i kontrollerede laboratorieforsøg, dyreforsøg og menneskeforsøg. 
Sativex has gone through the official authorisation procedure, which means it has been tested in controlled laboratory trials, animal trials and human trials.
Sativex bliver lavet af lægemiddelvirksomheden GW Pharmaceuticals, som også forsker i andre typer lægemidler baseret på cannabis. 
Sativex is manufactured by GW Pharmaceuticals, a pharmaceutical company that carries out research with other types of cannabis-based medicines as well.
Det er en mundhulespray baseret på et ekstrakt af cannabis. 
Sativex® is an oromucosal spray based on an extract of cannabis.
Gem formularens indhold på egen harddisk 
Save the form's contents on your hard drive
Gem formularens indhold på egen harddisk 
Save the form’s contents on your hard drive
om databeskyttelse vedtaget af en tilsynsmyndighed eller kontraktbestemmelser godkendt af en tilsynsmyndighed. 
scale of special categories of personal data and data relating to criminal convictions and offences, a person with
Skan af prøvepakning (ydre og indre emballage) fra eksportlandet, påført ansøgerens navn, dato for ansøgning samt eksportland. 
Scanned images of the specimen package (inner and outer packaging) from the export country, bearing the name of the applicant, date of application and name of export country.
Bilag 1 til bekendtgørelsen om euforiserende stoffer nr. 557 af 31. maj 2011 angiver nummeret på stoffet samt stoffets navn. 
Schedule 1 to the executive order no. 557 of 31 May 2011 on euphoriant substances shows the name and number of the individual substances.
Ordning om én sagkyndig person på § 39-tilladelsen 
Scheme for one qualified person authorised and listed on the section 39 authorisation.
Ordning om flere sagkyndige personer på § 39-tilladelsen 
Scheme for several qualified persons authorised and listed on the section 39 authorisation
Ordning om flere sagkyndige personer på § 39-tilladelsen 
Scheme for several qualified persons authorised and listed on the section 39 authorisation.
Schroll Medical ApS (tilladelse sendt 12. april 2018) 
Schroll Medical ApS (authorisation sent 12 April 2018)
Scientific advice-procedurer. 
Scientific advice procedures.
Videnskabelig rådgivning skal fremme forskning og innovation 
Scientific advice to promote research and innovation
Videnskabelig vurdering af fordele og ulemper 
Scientific evaluation of the benefit-risk balance
Der er videnskabelig evidens for, at ældre p-pille-typer, som også kaldes 2. generations p-piller, giver lavere risiko for blodpropper end de nyere typer (3. og 4. generations p-piller). 
Scientific evidence shows that the older 2nd generation contraceptive pills are associated with a lower risk of blood clots compared to the newer 3rd and 4th generation contraceptive pills.
En videnskabelig betegnelse efterfulgt af et varemærke eller navnet på indehaveren af markedsføringstilladelsen 
Scientific name followed by a trademark or the name of the marketing authorisation holder
Videnskabelig betegnelse efterfulgt af et varemærke eller navnet på indehaveren af markedsføringstilladelsen 
Scientific name followed by a trademark or the name of the marketing authorisation holder
sletning eller tilintetgørelse 
scientific research purpose.
Videnskabelige selskaber og patientforeninger er orienteret. 
Scientific societies and patient organisations have been informed.
lovovertrædelser, og sandsynligvis ikke indebærer en risiko for fysiske personers rettigheder og frihedsrettigheder 
scope, context and purposes of the processing and the risk to the rights and freedoms of natural persons.
Scope, field of application, definition (formål) 
Scope, field of application, definition
Scopoderm®-depotplastre og synsforstyrrelser, side 5 
Scopoderm® transdermal patches and visual disturbances, page 5
Du kan se billeder af produkterne og pakningerne længere nede. 
Scroll down to see images of the products and packages.
Søgning - giver mulighed for at søge på lægemiddel, virksomt stof og/eller varenummer. 
Search - this part enables you to search for a medicinal product, an active substance and/or a product number.
Søg i lister over omfattede virksomheder 
Search lists of companies involved
Søgemuligheder (filtre) 
Search options (filters)
Søgning i EudraGMDP databasen 
Search the EudraGMDP database
Søg i liste over omfattede virksomheder 
Search the list of companies involved
Søg i liste over tandlæger med tilknytning til virksomheder 
Search the list of dentists who have a relationship with a company
Søg i liste over læger med tilknytning til virksomheder 
Search the list of doctors who have a relationship with a company
Søg i liste over sygeplejersker med tilknytning til virksomheder 
Search the list of nurses who have a relationship with a company
Søg i liste over personer, der modtager økonomisk støtte 
Search the list of persons who receive financial support
Sekundær dataindsamling af bivirkninger fra non-interventionsstudier skal ikke indsendes løbende til Lægemiddelstyrelsen, men kun indgå i den endelige studierapport. 
Secondary data collection of adverse reactions from non-interventional studies should not be submitted to the Danish Medicines Agency on an ongoing basis.
Sekundær profylakse af iskæmisk hjertesygdom, TCI/iskæmisk cerebralt insult, perifer arteriel insufficiens samt til diabetespatienter (alle med total-kolesterol over 3,5 mmol/l efter livsstilsændring). 
Secondary prevention of ischaemic heart disease, TIA/ischaemic stroke, peripheral arterial insufficiency and diabetic patients (all patient categories with a total cholesterol level above 3.5 mmol/L after lifestyle changes).
For det andet kræver vurderingen af klinisk betydning mere nuancerede overvejelser og inddragelse af relevant lægelig ekspertise. 
Secondly, assessment of clinical significance requires considerations that are more varied and the involvement of relevant medical expertise.
For det andet, kan der være forhold som gør, at et cannabismellemprodukt i en periode ikke er tilgængeligt, fx hvis der opstår leveringsproblemer hos fremstilleren. 
Secondly, conditions could make a cannabis intermediate product unavailable for a period of time, for example if the manufacturer is faced with supply difficulties.
For det andet kan der selv ved 'rigtige' doser være bivirkninger, der kræver lægelig overvågning og evt. indgriben. 
Secondly, even at ‘right' doses, side effects requiring medical supervision and possibly intervention could occur.
For det andet kan der selv ved 'rigtige' doser være bivirkninger, der kræver lægelig overvågning og evt. indgriben. 
Secondly, even at ‘right’ doses, side effects requiring medical supervision and possibly intervention could occur.
For det andet er medicinmarkedet karakteriseret ved, at det er den sociale sygesikring og ikke forbrugeren, der i sidste instans afholder medicinudgifterne. 
Secondly, the medicinal market is characterised by the fact that, ultimately, the national health insurance system and not the consumer pays the medicinal costs.
Vi har samtidig rettet op på nogle mangler, som ikke tidligere har kunne lade sig gøre teknisk. 
Secondly, we have corrected some errors that we have not been able to correct previously due to technical issues.
Derefter vender vi blikket indad mod den IT-leveranceorganisation, der er nødvendig for at kunne levere. 
Secondly, we look at our internal IT delivery organisation that is required to be able to deliver.
Rådets sekretariat 
Secretariat
Farmakopénævnets sekretariat 
Secretariat of the Danish Pharmacopoeia Commission
Lægemiddelnævnets sekretariat 
Secretariat of the Medicinal Products Committee
meddelelser fra sekretariatet 
Secretariat's report
I GMP bekendtgørelsens § 23, stk. 3 er det angivet, at alle kritiske fremstillingsprocesser skal valideres regelmæssigt. 
Section 23(3) of the GMP executive order provides that all critical manufacturing processes must be validated regularly.
Afsnit 2.: Indførsel og distribution 
Section 2: Importation and distribution operations
Af §3 fremgår, at Lægemiddelstyrelsen foretager revurderingen, og at revurderingen skal ske i overenstemmelse med de kriterier, der er fastsat i bekendtgørelsen for tildeling af generelt tilskud. 
Section 3 provides that it is the Danish Medicines Agency that performs the reassessment and that the reassessment is to take place in compliance with the criteria established in the executive order on the granting of general reimbursement.
Indlægssedlen pkt. 4: 
Section 4 of the package leaflet
Pkt. 4.6 Advarsler vedrørende graviditet og amning 
Section 4.6 Warnings related to fertility, pregnancy and lactation
Lægemiddellovens § 90, stk. 5, er ændret. 
Section 90(5) of the Danish Medicines Act has been amended.
Sikker og krypteret formular 
Secure and encrypted form
Sikker mailkorrespondance med NemID medarbejdersignatur 
Secure emails with a NemID employee certificate
Nethandel med fornuft 
Secure online shopping
Sikkerhedsadministrator (SA) - kan oprette virksomhedsadministratorer med adgang til en eller flere services. 
Security Administrator (SA) - can create company administrators with access to one or more services.
Sikkerhedsadministrator (SA) – kan oprette virksomhedsadministratorer med adgang til en eller flere services. 
Security Administrator (SA) – can create company administrators with access to one or more services.
Sikkerhedsadministratorer og brugere, der arbejder for virksomheder, som ikke har et dansk CVR-nummer, skal have udstedt et LBC-certifikat af Lægemiddelstyrelsen (se blanket i boksen). 
Security Administrators and users working for companies that do not have a Danish company registration number (CVR number) must be issued a CUG certificate from the Danish Medicines Agency (please see the form in the box).
Sikkerhedsadministratorer og brugere, der arbejder for virksomheder, der ikke har et dansk CVR-nummer skal have udstedt et LBC-certifikat af Lægemiddelstyrelsen (se blanket i boksen). 
Security administrators and users working for companies that do not have a Danish company registration number must be issued a CUG certificate from the Danish Medicines Agency (please see the form in the box to the right).
Sikkerhed og drift ved overførsel af XML-fil 
Security and operation when transferring an XML file
Sikkerhed og drift ved overførsel af XML-fil: 
Security and operation when transferring an XML file:
Sager om ulovlig forhandling af lægemidler 
Security clearance of employees who handle heroine
Sikkerhedsgodkendelser af ansatte som håndterer heroin 
Security clearance of employees who handle heroine
a) et retligt bindende instrument, som kan håndhæves, mellem offentlige myndigheder eller organer 
security measures, including rules for the onward transfer of personal data to another third country or international
Se ” Retningslinjer for elektroniske ansøgninger ”. 
See "Guidelines on submission of electronic applications" .
Se ”Retningslinjer for elektroniske ansøgninger”. 
See "Guidelines on submission of electronic applications".
Se "Tekniske detaljer i forbindelse med elektroniske ansøgninger" vedr. "baseline" samt første eCTD-baserede indsendelse. 
See "Technical details for electronic applications" regarding "baseline" as well as first eCTD-based submission.
Se listen over nogle af de cannabisolier, vi har vurderet 
See a list of some of the cannabis oils we have assessed
Se liste over de stoffer, der i Danmark betragtes som doping . 
See a list of substances considered doping substances in Denmark (in Danish only).
Se liste over de stoffer, der i Danmark betragtes som doping. 
See a list of substances considered doping substances in Denmark (in Danish only).
Se også artikel 46 og 47 i forordningen om sikkerhedselementer i det øverste link. 
See also articles 46 and 47 of the regulation on safety features in the link above.
Der henvises i øvrigt til vores vejledning nr. 29 af 24. maj 2007 om reklame m.v. for lægemidler. 
See also guidelines no. 29 of 24 May 2007 from the Danish Medicines Agency on advertising etc. for medicinal products.
Se endvidere Spørgsmål og svar. 
See also Questions and answers
Se desuden § 70 og bilag 4 om udenlandske recepter i bekendtgørelse nr. 1108 af 29. september 2017 om recepter og dosisdispensering af lægemidler 
See also section 70 and appendix 4 about foreign prescriptions in executive order no. 1108 of 29 September 2017 on prescriptions and dose dispensing of medicinal products (in Danish)
Se også Lægemiddelstyrelsens Spørgsmål og svar vedr. praksis for godkendelse af flere sagkyndige personer på fremstillertilladelsen for yderligere information om ordningerne. 
See also the Danish Medicines Agency's Questions and answers about procedure for authorisation of several qualified persons on the MIA for more information on the schemes.
Se endvidere nedenfor under compliance. 
See also the section “Compliance” below.
Se eventuelt: http://www.ema.europa.eu 
See also: http://www.ema.europa.eu
Se også forordningens artikel 13. 
See article 13 of the regulation.
Se bl.a. artikel 4. 
See Article 4.
Se i den forbindelse artikel 54a i direktivet om lægemidler til mennesker. 
See article 54a of the Directive on medicinal products for human use
Se Community register 
See Community register
Se EMA's hjemmeside 
See EMA's website
Se EMA's hjemmeside under det enkelte produkts EPAR 
See EMA's website under the EPAR of the individual product
Se EU's liste med anbefalinger i forbindelse med sikkerhedssignaler: PRAC 
See EU's list of recommendations on safety signals: PRAC recommendations on
Se EU's liste med anbefalinger i forbindelse med sikkerhedssignaler: PRAC recommendations on signals adopted 28 November-1 December 2016 samt de danske oversættelser til produktinformationen. 
See EU's list of recommendations on safety signals: PRAC recommendations on signals adopted 28 November - 1 December 2016 as well as the Danish translations of the product information.
Se EU's liste med anbefalinger i forbindelse med sikkerhedssignaler: PRAC recommendations on signals adopted 3-6 April 2017 samt de danske oversættelser til produktinformationen. 
See EU's list of recommendations on safety signals: PRAC recommendations on signals adopted 3-6 April 2017 as well as the Danish translations of the product information.
Se EU's liste med anbefalinger i forbindelse med sikkerhedssignaler: PRAC recommendations on signals adopted 6-9 February 2017 samt de danske oversættelser til produktinformationen 
See EU's list of recommendations on safety signals: PRAC recommendations on signals adopted 6-9 February 2017 as well as the Danish translations of the product information
Se EU's liste med anbefalinger i forbindelse med sikkerhedssignaler: PRAC recommendations on signals adopted 6-9 March 2017 samt de danske oversættelser til produktinformationen. 
See EU's list of recommendations on safety signals: PRAC recommendations on signals adopted 6-9 March 2017 as well as the Danish translations of the product information.
Se EU's liste med anbefalinger i forbindelse med sikkerhedssignaler: PRAC recommendations on signals June 2016 og PRAC recommendations on signals July 2016 samt de danske oversættelser til produktinformationen fra Juni og danske oversættelser til produktinformationen fra juli. 
See EU's list of recommendations on safety signals: PRAC recommendations on signals June 2016 and PRAC recommendations on signals July 2016 as well as the Danish translations of the product information from June and Danish translations of the product information from July.
Se EU's liste med anbefalinger i forbindelse med sikkerhedssignaler: PRAC recommendations on signals March 2016 samt de danske oversættelser til produktinformationen. 
See EU's list of recommendations on safety signals: PRAC recommendations on signals March 2016 as well as the Danish translations of the product information.
Se EU's liste med anbefalinger i forbindelse med sikkerhedssignaler: PRAC recommendations on signals May 2016 samt de danske oversættelser til produktinformationen. 
See EU's list of recommendations on safety signals: PRAC recommendations on signals May 2016 as well as the Danish translations of the product information.
Se EU's liste med anbefalinger i forbindelse med sikkerhedssignaler: PRAC recommendations on signals September samt de danske oversættelser til produktinformationen. 
See EU's list of recommendations on safety signals: PRAC recommendations on signals, September as well as the Danish translations for the product information.
Se også bekendtgørelse nr. 1491 af 14. december 2006 om tilskud til ernæringspræparater. 
See executive order no. 1491 of 14 December 2006 on reimbursement for nutritional products (in Danish)
Se Vejledning til virksomhed og regnskab med euforiserende stoffer 
See Guidelines for activities with and accounts on euphoriant substances (in Danish)
Se Hvordan reklamerer du for dit produkt? 
See How to advertise your product
Se infografik. 
See infographics.