FrancophonIA/ELRC3.0 huggingface dataset:
English: Glybera has minor influence on the ability to drive and use machines¸ dizziness was commonly observed after Glybera administration (see section 4.8).
Danish: Glybera påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Chiesi Pharma AB Puh/Tel: : +46 8 753 35 20
Danish: Chiesi Pharma ABPuh/ Tel: + 46 8 753 35 20
English: Glybera 3 × 1012 genome copies/ml solution for injection
Danish: Glybera, injektionsvæske, opløsning, 3 × 1012 genomkopier/ml
English: 1) Educational material for Pharmacists including the following key safety elements: • Detailed guidelines for product receipt and storage, procedure for the preparation, handling
Danish: 1) Informationsmateriale til farmaceuter, som indeholder følgende vigtige elementer: vedrørende
English: • muscle pain and joint aches, pains and stiffness
Danish: Knogler, led, muskler og bindevæv
English: Number of vials (1 mL) Number of 1ml syringes (each filled with 0.5ml)
Danish: Legemsvægt (kg) Antal hætteglas (1 ml)
English: Chiesi Farmaceutici S.p.A. Tηλ: + 39 0521 2791
Danish: Tηλ: + 39 0521 2791
English: Renal impairment or hepatic impairment
Danish: Nedsat nyrefunktion eller nedsat leverfunktion
English: Contusion
Danish: • træthed
English: Package leaflet: Information for the user Glybera 3 x 1012 genome copies /ml solution for injection
Danish: injektionsvæske, opløsning, 3 × 1012 genomkopier/ml
English: • Oral contraceptives (see section 2 ‘Do not receive Glybera')
Danish: 2 “ Du må ikke få Glybera”.
English: Individual lot number: Date of treatment:
Danish: Oversigt over indlægssedlen:
English: - If you get any side effects, talk to your doctor.
Danish: - Kontakt lægen, hvis du får bivirkninger, herunder bivirkninger som ikke er nævnt her.
English: Store and transport vial frozen -25oC to -15oC.
Danish: Hætteglasset opbevares og transporteres nedfrosset ved -25 °C til -15 °C.
English: EU/1/13/869/001 Lemtrada
Danish: EU/1/13/869/001
English: 1.2 ml (10 mg/ml) 1 vial
Danish: 1,2 ml (10 mg/ml) 1 hætteglas
English: 12 mg Concentrate for solution for infusion
Danish: 12 mg Koncentrat til infusionsvæske, opløsning
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Danish: MF (EU)-nummer
English: Official languages:
Danish: Officielle sprog:
English: Guidelines and scientific advice
Danish: Retningslinjer og videnskabelig rådgivning
English: EU Member States: 28
Danish: EU ‘s medlemsstater: 28
English: Supporting regulatory science outside the EU - the Article 58 procedure
Danish: Støtte til reguleringsmæssig videnskab uden for EU - artikel 58-proceduren
English: The European system offers different routes for such an authorisation.
Danish: Det europæiske system tilbyder forskellige veje til en sådan tilladelse.
English: Different authorisation routes: one set of common rules.
Danish: Forskellige godkendelsesprocedurer: ét sæt fælles regler.
English: The European Union - key facts
Danish: Den Europæiske Union - fakta
English: The European Economic Area (EEA) is formed of the 28 EU Member States plus:
Danish: Det Europæiske Økonomiske Samarbejdsområde (EØS) er dannet af 28 EU-medlemsstaterne plus:
English: This process allows Member States to rely on each other's scientific assessments.
Danish: Denne proces gør det muligt for medlemsstaterne at benytte hinandens videnskabelige vurderinger.
English: Pricing and reimbursement
Danish: Pris og refusion
English: National Competent Authorities
Danish: Nationale kompetente myndigheder
English: The European Commission can also take action concerning other aspects of medicine regulation:
Danish: Europa-Kommissionen kan også træffe foranstaltninger i forbindelse med andre aspekter af lægemiddelregulering:
English: The role of EMA
Danish: EMA's rolle
English: These guidelines reflect the latest thinking on developments in biomedical science.
Danish: Disse retningslinjer afspejler de nyeste tanker om udviklingen inden for biomedicin.
English: Population: >500m
Danish: Befolkning: over 500 millioner
English: • Right of initiative - it can propose new or amended legislation for the pharmaceutical sector;
Danish: • Initiativret - den kan foreslå nye eller ændrede retsakter til lægemiddelsektoren.
English: International cooperation
Danish: Internationalt samarbejde
English: The regulatory authorities of each Member State are responsible for granting licences for such activities taking place within their respective territories.
Danish: Reguleringsmyndighederne i de enkelte medlemsstater er ansvarlige for at udstede licenser til sådanne aktiviteter, der foregår på deres respektive områder.
English: When a company wants to authorise a medicine in several Member States, it can use one of the following procedures:
Danish: Når en virksomhed ønsker at få godkendt et lægemiddel i flere medlemsstater, kan den benytte en af følgende procedurer:
English: Public hearings
Danish: Offentlige høringer
English: Authorisation and supervision of manufacturers
Danish: Godkendelse og overvågning af producenter
English: The role of the European Commission
Danish: Europa-Kommissionens rolle
English: These data are continuously monitored by EMA and the Member States in order to identify any new safety information.
Danish: Disse data overvåges løbende af EMA og medlemsstaterne for at identificere eventuelle nye sikkerhedsoplysninger.
English: • Global outreach - it ensures appropriate collaboration with relevant international partners and promotes the EU regulatory system globally.
Danish: • Globale outreach-aktiviteter - den sikrer et passende samarbejde med relevante internationale partnere og fremmer EU's reguleringssystem globalt.
English: This network is what makes the EU regulatory system unique.
Danish: Det er dette netværk, der gør EU's reguleringssystem unikt.
English: The PRAC has a broad remit covering all aspects of pharmacovigilance.
Danish: PRAC har en bred kompetence, der dækker alle aspekter af lægemiddelovervågning.
English: Clinical trials
Danish: Kliniske forsøg
English: EMA's scientific committees
Danish: EMA's videnskabelige udvalg
English: Increasingly, patients and healthcare professionals are involved in the work of the Agency including in the evaluation of medicines.
Danish: Patienter og sundhedspersonale involveres i stadig større grad i agenturets arbejde, herunder i vurderingen af lægemidler.
English: GDP: € 12.9tn
Danish: BNP: 12,9 billioner euro
English: EMA prepares scientific guidelines in cooperation with experts from its scientific committees and working groups.
Danish: EMA udarbejder videnskabelige retningslinjer i samarbejde med eksperter fra dets videnskabelige udvalg og arbejdsgrupper.
English: The European Commission plays an important role in the regulation of medicines in the EU.
Danish: Europa-Kommissionen spiller en vigtig rolle i reguleringen af lægemidler i EU.
English: Marketing authorisations
Danish: Markedsføringstilladelser
English: Medicines eligible for this procedure, which is derived from Article 58 of the regulation founding the Agency, are used to prevent or treat diseases that impact global public health.
Danish: Lægemidler, der hører ind under denne procedure, som er afledt af artikel 58 i forordningen om etableringen af agenturet, anvendes til at forebygge eller behandle sygdomme, der påvirker den globale folkesundhed.
English: Transparency about how the system works and how it reaches its decisions is an important feature of the EU regulatory system for medicines.
Danish: Gennemsigtighed i forhold til, hvordan det virker, og hvordan det træffer sine afgørelser, er et vigtigt element i EU's reguleringssystem for lægemidler.
English: By working closely together, Member States reduce duplication, share the workload and ensure the efficient and effective regulation of medicines across the EU.
Danish: Ved at arbejde tæt sammen reducerer medlemsstaterne dobbeltarbejde, deler arbejdsbyrden og sikrer en effektiv og virkningsfuld regulering af lægemidler i hele EU.
English: Experts participate in the work of EMA as members of its scientific committees, working parties, scientific advisory groups and other ad hoc advisory groups, or as members of the national assessment teams that evaluate medicines.
Danish: Eksperter deltager i arbejdet i EMA som medlemmer af dets videnskabelige udvalg, arbejdsgrupper, videnskabelige rådgivende grupper og andre ad hoc-rådgivningsgrupper eller som medlemmer af de nationale team, der vurderer lægemidler.
English: ICH is dedicated to harmonisation in safety, quality and efficacy as the main criteria for approving and authorising new medicines.
Danish: ICH fokuserer på harmonisering inden for sikkerhed, kvalitet og effektivitet som de vigtigste kriterier for at godkende og udstede tilladelse til nye lægemidler.
English: • Implementation - it can adopt implementing measures as well as oversee the correct application of EU law on pharmaceuticals;
Danish: • Gennemførelse - den kan vedtage gennemførelsesforanstaltninger samt føre tilsyn med, at EU's lægemiddellovgivning anvendes korrekt.
English: There are also a number of bilateral cooperation agreements in place that facilitate the exchange of important information on medicines between regulators inside and outside the EU.
Danish: Der findes desuden en række bilaterale samarbejdsaftaler, der gør det lettere at udveksle vigtige oplysninger om lægemidler mellem reguleringsmyndigheder i og uden for EU.
English: These activities aim to foster the timely exchange of regulatory and scientific expertise and the development of best practices in the regulatory field across the world.
Danish: Disse aktiviteter har til formål at fremme en rettidig udveksling af reguleringsmæssig og videnskabelig ekspertise og udvikle bedste praksis på reguleringsområdet i hele verden.
English: The EMA has seven scientific committees that carry out its scientific assessments:
Danish: EMA har syv videnskabelige udvalg, der foretager agenturets videnskabelige vurderinger:
English: This works because EU legislation requires that each Member State operates to the same rules and requirements regarding the authorisation and monitoring of medicines.
Danish: Dette fungerer, fordi det i EU-lovgivningen kræves, at hver enkelt medlemsstat skal benytte de samme regler og krav vedrørende godkendelse og overvågning af lægemidler.
English: This includes vaccines used in the WHO Expanded Programme on Immunization, or for protection against a public health priority disease, as well as medicines for WHO target diseases such as HIV/AIDS, malaria or tuberculosis.
Danish: Dette omfatter vacciner, der anvendes i WHO's udvidede vaccinationsprogram, eller til beskyttelse mod en prioriteret folkesygdom samt til WHO's målrettede sygdomme som HIV/AIDS, malaria eller tuberkulose.
English: The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and EMA.
Danish: er baseret på et netværk af omkring 50 regulerings myndigheder fra de 31 EØS-lande (28 EU-medlemsstater plus Island, Liechtenstein og Norge), Europa-Kommissionen og EMA.
English: Medicines regulatory authorities:
Danish: Lægemiddelregulerende myndigheder:
English: Regulatory cooperation and exchange of information with international regulators is also assured through the International Pharmaceutical Regulators' Forum (IPRF).
Danish: Reguleringsmæssigt samarbejde og udveksling af oplysninger med internationale reguleringsmyndigheder sikres ligeledes gennem forummet af internationale lægemiddelregulerende myndigheder (IPRF).
English: Accession to the EU means a commitment to apply the “acquis communautaire” (the body of EU legislation and guidance) to ensure that all EU Member States operate to the same standards.
Danish: Tiltrædelse til EU medfører en forpligtelse til at anvende ”den gældende fællesskabsret” (EU's lovgivning og vejledninger) for at sikre, at alle EU's medlemsstater følger samme standarder.
English: The regulation of medical devices does not fall within the scope of the European regulatory system for medicines.
Danish: Regulering af medicinsk udstyr hører ikke ind under anvendelsesområdet for det europæiske reguleringssystem for lægemidler.
English: The use of the centrally authorised procedure is compulsory for most innovative medicines, including medicines for rare diseases.
Danish: Det er obligatorisk at bruge en centraliseret godkendelsesprocedure for de mest innovative lægemidler, herunder lægemidler til sjældne sygdomme.
English: EMA also gives product-specific scientific advice to companies for the development of medicines.
Danish: EMA yder også produktspecifik rådgivning til virksomheder i forbindelse med udvikling af lægemidler.
English: If there is a safety issue with a medicine that is authorised in more than one Member State, the same regulatory action is taken across the EU and patients and healthcare professionals in all Member States are provided with the same guidance.
Danish: I tilfælde af et sikkerhedsspørgsmål vedrørende et lægemiddel, som er godkendt i mere end én medlemsstat, træffes de samme reguleringsforanstaltninger i hele EU, og patienter og sundhedspersonale i alle medlemsstater får samme vejledning.
English: Inspection outcomes can be accessed by all Member States and are made publicly available across the EU through EudraGMDP.
Danish: Resultatet af kontrollen kan tilgås af alle medlemsstater og offentliggøres i hele EU gennem EudraGMDP.
English: A strategic forum at the level of global agencies has recently been established - the International Coalition of Medicines Regulatory Authorities (ICMRA).
Danish: Der er for nyligt etableret et strategisk forum på samme niveau som globale agenturer - den internationale koalition af lægemiddelregulerende myndigheder (ICMRA).
English: When assessing these medicines, the CHMP applies the same rigorous standards as for medicines intended for use inside the EU.
Danish: I sin vurdering af disse lægemidler anvender CHMP samme strenge standarder som til lægemidler bestemt til anvendelse inden for EU.
English: Public hearings are intended to support the committee's decision-making by providing perspectives, knowledge and insights into the way medicines are used in clinical practice.
Danish: Formålet med offentlige høringer er at støtte udvalgets beslutningsproces ved at give perspektiver, viden og indsigt i den måde, lægemidler anvendes på i klinisk praksis.
English: The European Commission and EMA, in close cooperation with Member States, work to forge close ties with partner organisations around the world.
Danish: Europa-Kommissionen og EMA arbejder tæt sammen med medlemsstaterne om at skabe tætte bånd til part nerorganisationer rundt om i verden.
English: Manufacturers, importers and distributors of medicines in the EU must be licensed before they can carry out those activities.
Danish: Producenter, importører og distributører af lægemidler i EU skal godkendes, inden de kan gennemføre disse akti viteter.
English: The European regulatory system for medicines monitors the safety of all medicines that are available on the European market throughout their life span.
Danish: Det europæiske reguleringssystem for lægemidler over våger sikkerheden af alle lægemidler, som er tilgængeli ge på det europæiske marked i hele deres levetid.
English: The EU has developed a single market through a standardised system of laws that apply to all its Member States.
Danish: Den Europæiske Union (EU) har udviklet et indre marked gennem et standardiseret system af love, der gælder alle Unionens medlemsstater.
English: All manufacturing and importing licenses are entered into EudraGMDP, the publiclyavailable European database operated by EMA.
Danish: Alle fremstillings- og importlicenser indtastes i EudraGMDP, EMA's offentligt tilgængelige europæiske database.
English: EMA has a committee dedicated to the safety of medicines for human use - the Pharmacovigilance Risk Assessment Committee, or PRAC.
Danish: EMA har et udvalg, der tager sig af sikkerheden af lægemidler til human brug - Udvalget for Risikovurdering inden for Lægemiddelovervågning eller PRAC.
English: The experts are chosen on the basis of their scientific expertise and many of them are made available to EMA by the NCAs in Member States.
Danish: Eksperterne vælges på grundlag af deres videnskabelige ekspertise, og de fleste stilles til rådighed for EMA af de nationale kompetente myndigheder i medlemsstaterne.
English: The European Clinical Trials Database (EudraCT) tracks which clinical trials have been authorised in the EU.
Danish: Den europæiske database over kliniske forsøg (EudraCT) sporer de kliniske forsøg, som er blevet godkendt af EU.
English: EMA was established in 1995 to ensure the best use of scientific resources across Europe for the evaluation, supervision and pharmacovigilance of medicines.
Danish: EMA blev etableret i 1995 for at sikre den bedst mulige udnyttelse af videnskabelige ressourcer på tværs af Europa til vurdering af, tilsyn med og overvågning af lægemidler.
English: To protect public health and ensure the availability of high quality, safe and effective medicines for European citizens, all medicines must be authorised before they can be placed on the market in the EU.
Danish: For at beskytte folkesundheden og sikre, at europæiske borgere har adgang til sikre og effektive lægemidler af høj kvalitet, skal alle lægemidler godkendes, inden de kan markedsføres i EU.
English: EMA provides public access to reports of suspected side effects for centrally-authorised medicines in the European database of suspected drug-reaction reports.
Danish: EMA giver offentlig adgang til rapporter om mistænkte bivirkninger for centralt godkendte lægemidler i den europæiske database over rapporter om mistænkte lægemiddelreaktioner.
English: Once a marketing authorisation has been granted, decisions about price and reimbursement take place at the level of each Member State considering the potential role and use of the medicine in the context of the national health system of that country.
Danish: Når en markedsføringstilladelse er blevet udstedt, træffes afgørelser om pris og refusion i den enkelte medlemsstat på grundlag af lægemidlets potentielle rolle og anvendelse inden for rammerne af det pågældende lands nationale sundhedssystem.
English: The European Commission and EMA work with the World Health Organization (WHO) on a range of issues, including medicines intended for markets outside the EU (medicines reviewed under EMA's so-called ‘Article 58 procedure'), the quality of medicines and the development of international nonproprietary names.
Danish: Europa-Kommissionen og EMA samarbejder med Verdenssundhedsorganisationen (WHO) om en række spørgsmål, herunder lægemidler bestemt til markeder uden for EU (lægemidler gennemgået i henhold til EMA's såkaldte ”artikel 58-procedure”), kvaliteten af lægemidler og udvikling af internationale fællesnavne.
English: In addition, the EU's pharmacovigilance legislation enables the PRAC to hold public hearings during safety reviews of medicines if deemed useful.
Danish: Derudover giver EU's lovgivning om lægemiddelover vågning PRAC mulighed for at holde offentlige høringer i forbindelse med sikkerhedsgennemgange af lægemidler, hvis dette skønnes nyttigt.
English: This website allows users to view all suspected side effect reports submitted to EudraVigilance
Danish: Dette websted giver brugerne mulighed for at se alle rapporter om mistænkte bivirkninger, som er indgivet til EudraVigilance.
English: This booklet explains how the European regulatory system for medicines operates.
Danish: I dette hæfte forklares det, hvordan det europæiske reguleringssystem for lægemidler fungerer.
English: The national competent authorities (NCAs), responsible for the regulation of human and veterinary medicines in the EU, coordinate their work in a forum called Heads of Medicines Agencies (HMA).
Danish: De nationale kompetente myndigheder, som er ansvarlige for regulering af humane og veterinære lægemidler i EU, koordinerer deres arbejde i et forum kaldet lederne af lægemiddelstyrelserne.
English: All suspected side effects that are reported by patients and healthcare professionals must be entered into EudraVigilance, the EU web-based information system operated by EMA that collects, manages and analyses reports of suspected side effects of medicines.
Danish: Alle mistænkte bivirkninger, som indberettes af patienter og sundhedspersonale, skal indtastes i EudraVigilance, EU's internetbaserede informationssystem, som styres af EMA, og som anvendes til indsamling, styring og analyse af rapporter om mistænkte bivirkninger ved lægemidler.
English: In addition to its role in risk assessment, the committee provides advice and recommendations to the European medicines regulatory network on risk management planning and benefit-risk assessment for medicines after marketing.
Danish: Ud over sin rolle i forbindelse med risikovurdering yder udvalget rådgivning og kommer med anbefalinger til det europæiske reguleringsnetværk for lægemidler om planlægning af risikostyring og vurderinger af fordele og risici ved lægemidler efter markedsføringen.
English: EMA and the Member States cooperate and share expertise in the assessment of new medicines and of new safety information.
Danish: EMA og medlemsstaterne samarbejder og deler erfaringer med vurdering af nye lægemidler og nye sikkerhedsoplysninger.
English: On the basis of scientific assessments carried out by EMA, it grants or refuses, changes or suspends marketing authorisations for medicines that have been submitted via the centralised procedure.
Danish: På grundlag af en videnskabelig vurdering foretaget af EMA udsteder eller afviser den at udstede, ændrer eller suspenderer den markedsføringstilladelser til lægemidler, som er blevet indgivet via den centraliserede procedure.
English: This is an important tool to help develop and make available high-quality, effective and safe medicines, for the benefit of patients.
Danish: Dette er et vigtigt værktøj til at lette udviklingen af og adgangen til effektive og sikre lægemidler af høj kvalitet til fordel for patienterne.
English: Pharmaceutical companies submit a single authorisation application to EMA.
Danish: Medicinalvirksomheder indsender en enkelt ansøgning om markedsføringstilladelse til EMA.
English: If the product is manufactured outside the EU and has been imported, it needs to undergo full analytical testing in the EU, unless a mutual recognition agreement (MRA) is in place between the EU and the exporting country.
Danish: Hvis produktet er fremstillet uden for EU og er blevet importeret, skal det gennemgå en fuld analytisk test i EU, medmindre der foreligger en aftale om gensidig anerkendelse mellem EU og det eksporterende land.
English: The CHMP can carry out scientific assessments and give opinions, in cooperation with WHO, on medicines for use exclusively outside the EU.
Danish: CHMP kan foretage videnskabelige vurderinger og afgive udtalelser i samarbejde med WHO om lægemidler bestemt til anvendelse udelukkende uden for EU.
English: Rules and requirements applicable to pharmaceuticals in the EU are the same, irrespective of the authorisation route for a medicine.
Danish: Regler for og krav til lægemidler i EU er de samme, uanset godkendelsesproceduren for et lægemiddel.
English: The centralised procedure allows the marketing of a medicine on the basis of a single EU-wide assessment and marketing authorisation which is valid throughout the EU.
Danish: Den centraliserede procedure giver mulighed for at markedsføre et lægemiddel på grundlag af en enkelt EU-dækkende vurdering og markedsføringstilladelse, som er gyldig i hele EU.
English: A waiver applies for some countries which have applied to have their regulatory systems for the supervision of manufacturers of active pharmaceutical ingredients assessed by the EU and have been found to be equivalent to the EU.
Danish: Der gives dispensation for visse lande, som har ansøgt om at få deres reguleringssystemer til overvågning af producenter af aktive lægemiddelingredienser vurderet af EU, og som er blevet vurderet at svare til EU.